Örebro Studies in Care Sciences 49
E
MMAO
HLSSON-N
EVOColorectal cancer
Patients’ and next-of-kin’s experiences
and the effects of a psycho-educational program
EMMAOHLSSON-NEVO Colorectalcancer I 61
Table 4b. SF-36 summary scores (PCS, MCS)a of patients in the intervention (PEP) and control groups
PCS MCS
PEP CON pb ESc PEP CON p ES
Change 0-1 month 3.9 (8.18) 2.2 (10.1) 0.74 0.18 3.3 (12.7) -0.46 (10.0) 0.08 0.25 p-valued <0.01 0.16 0.03 0.87 SRMe 0.48 0.21 0.26 0.05 0-6 months 7.0 (9.36) 3.4 (11.6) 0.32 0.34 3.7 (8.9) 4.5 (10.5) 0.87 0.08 p-value <0.01 0.13 0.01 0.05 SRM 0.74 0.30 0.41 0.43 0-12 months 5.2 (10.7) 3.6 (12.2) 0.98 0.14 3.0 (9.9) 3.6 (12.8) 0.93 0.05 p-value <0.01 0.08 0.05 0.02 SRM 0.49 0.30 0.30 0.28
Values (except p-values, ES and SRM) represent the mean (SD) score. PCS=Physical Component Score, MCS= Mental component Score
aThe mean summary score for the general Swedish population was 50; lower scores indicate worse physical or mental health compared to the general population b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect)d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test), e SRM= Standardized Response Mean, e SRM= Standardized Response Mean
59 60 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er
RES
U
LT
TABL
ES
Ta bl e 4 a. S F-36 s um m ar y sc or es ( PC S, M C S) a of pa ti ent s in t he int er ve nt io n ( PE P) a nd c ont rol g roup s PCS M CS PEP CO N p b ES c PEP CO N p ES B as elin e 39. 1 ( 10. 3) 38. 5 ( 10. 9) 0. 91 0. 05 45. 7 ( 10. 8) 43. 8 ( 12. 3) 0. 75 0. 16 1 m ont h 42. 9 ( 12. 7) 44. 6 ( 11. 7) 0. 56 0. 07 49. 3 ( 12. 9) 43. 0 ( 11. 6) 0. 01 0. 51 6 m ont hs 46. 2 ( 11. 6) 42. 5 ( 10. 8) 0. 15 0. 33 49. 7 ( 11. 4) 47. 7 ( 10. 8) 0. 32 0. 18 12 m ont hs 44. 8 ( 11. 6) 41. 3 ( 13. 0) 0. 22 0. 28 48. 0 ( 12. 3) 46. 1 ( 12. 1) 0. 39 0. 16 V al ues ( ex cep t p -v al ue s an d ES ) r ep re se nt th e m ea n (S D ) sc ore . PC S=Phy si ca l C om pone nt S cor e, M C S= M ent al c om pone nt S cor e a T he m ea n s um m ar y s cor e f or t he g ene ra l S w ed is h popul at ion w as 50 ; l ow er s cor es ind ic at e w or se ph ys ic al or m ent al he al th com pa re d t o t he g ene ra l popul at ion b Tes t o f b et w een -g roup di ffe re nc es (M an n-W hi tne y U -te st) c E S= e ff ec t s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = la rg e ef fe ct ).60 I EMMAOHLSSON-NEVO Colorectalcancer
RESULT TABLES
Table 4a. SF-36 summary scores (PCS, MCS)a of patients in the intervention (PEP) and control groups
PCS MCS
PEP CON pb ESc PEP CON p ES
Baseline 39.1 (10.3) 38.5 (10.9) 0.91 0.05 45.7 (10.8) 43.8 (12.3) 0.75 0.16
1 month 42.9 (12.7) 44.6 (11.7) 0.56 0.07 49.3 (12.9) 43.0 (11.6) 0.01 0.51
6 months 46.2 (11.6) 42.5 (10.8) 0.15 0.33 49.7 (11.4) 47.7 (10.8) 0.32 0.18
12 months 44.8 (11.6) 41.3 (13.0) 0.22 0.28 48.0 (12.3) 46.1 (12.1) 0.39 0.16
Values (except p-values and ES) represent the mean (SD) score. PCS=Physical Component Score, MCS= Mental component Score
a The mean summary score for the general Swedish population was 50; lower scores indicate worse physical or mental health compared to the general population b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect).
E MM A O HL SS O N -N E VO C ol or ec ta lc anc er I 61 Ta bl e 4 b. S F-36 su m m ary sc ore s ( PC S, M C S) a of pa ti ent s i n t he int er ve nt io n ( PE P) a nd c ont rol g roup s PCS M CS PEP CO N p b ES c PEP CO N p ES C ha ng e 0-1 m ont h 3. 9 ( 8. 18) 2. 2 ( 10. 1) 0. 74 0. 18 3. 3 ( 12. 7) -0. 46 ( 10. 0) 0. 08 0. 25 p-val ue d <0. 01 0. 16 0. 03 0. 87 SRM e 0. 48 0. 21 0. 26 0. 05 0-6 m ont hs 7. 0 ( 9. 36) 3. 4 ( 11. 6) 0. 32 0. 34 3. 7 ( 8. 9) 4.5 ( 10. 5) 0. 87 0. 08 p-val ue <0. 01 0. 13 0. 01 0. 05 SRM 0. 74 0. 30 0. 41 0. 43 0-12 m ont hs 5. 2 ( 10. 7) 3. 6 ( 12. 2) 0. 98 0. 14 3. 0 ( 9. 9) 3. 6 ( 12. 8) 0. 93 0. 05 p-val ue <0. 01 0. 08 0. 05 0. 02 SRM 0. 49 0. 30 0. 30 0. 28 V al ues ( ex cep t p -v al ue s, E S and SR M ) r epr es ent t he m ea n (S D ) s cor e. PC S=Phy si ca l C om pone nt S cor e, M C S= M ent al c om pone nt S cor e aT he m ea n s um m ar y sc or e f or t he g ene ra l S w edi sh popu la ti on w as 50 ; l ow er s cor es ind ic at e w or se ph ys ic al or m ent al he al th com pa re d t o t he g ene ra l popul at ion b Tes t o f b et w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= e ff ec t s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = la rg e ef fe ct ) d Te st of w ith in -g roup c ha ng e f rom ba se line t o fol low -up ( W ilc oxon S ig ne d-ra nk te st) d Te st o f w ith in -g roup c ha ng e f ro m ba se line t o fol low -up ( W ilc oxon S ig ne d-ra nk te st), e SR M = S ta nda rd iz ed R es pons e M ea n, e SR M = S ta nda rd iz ed R es pons e M ea n
EMMAOHLSSON-NEVO Colorectalcancer I 61
Table 4b. SF-36 summary scores (PCS, MCS)a of patients in the intervention (PEP) and control groups
PCS MCS
PEP CON pb ESc PEP CON p ES
Change 0-1 month 3.9 (8.18) 2.2 (10.1) 0.74 0.18 3.3 (12.7) -0.46 (10.0) 0.08 0.25 p-valued <0.01 0.16 0.03 0.87 SRMe 0.48 0.21 0.26 0.05 0-6 months 7.0 (9.36) 3.4 (11.6) 0.32 0.34 3.7 (8.9) 4.5 (10.5) 0.87 0.08 p-value <0.01 0.13 0.01 0.05 SRM 0.74 0.30 0.41 0.43 0-12 months 5.2 (10.7) 3.6 (12.2) 0.98 0.14 3.0 (9.9) 3.6 (12.8) 0.93 0.05 p-value <0.01 0.08 0.05 0.02 SRM 0.49 0.30 0.30 0.28
Values (except p-values, ES and SRM) represent the mean (SD) score. PCS=Physical Component Score, MCS= Mental component Score
aThe mean summary score for the general Swedish population was 50; lower scores indicate worse physical or mental health compared to the general population b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect)d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test), e SRM= Standardized Response Mean, e SRM= Standardized Response Mean
62 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er T abl e 5. S F-36 phy si ca l s ub sc al e sco res a of pa ti ent s i n t he int er ve nt io n ( PE P n=4 7) a nd c ont rol ( C O N n =39) g roups Phy si ca l Func ti on Ro le -Phy si ca l B odi ly Pa in G en er al H ea lt h PEP C ON p b ES c PEP C ON p ES PEP C ON p ES PEP C ON p ES B as elin e 67. 0 (24. 2) 66. 5 (2. 9) 0. 85 0. 04 28. 7 (36. 5) 25. 8 (38. 8) 0. 62 0. 07 65. 2 (27. 0) 61. 0 (30. 5) 0. 51 0. 15 67. 1 (18. 5) 59. 1 (18. 4) 0. 05 0. 43 1 m ont h 72. 2 (25. 7) 73. 7 (24. 8) 0. 90 0. 06 54. 5 (44. 2) 47. 3 (44. 1) 0. 60 0. 16 75. 6 (29. 9) 64. 2 (20. 1) 0. 07 0. 38 64. 8 (19. 4) 54. 8 (18. 9) 0. 02 0. 52 6 m ont hs 75. 7 (24. 9) 74. 8 (23. 3) 0. 57 0. 04 62. 8 (41. 3) 61. 0 (40. 8) 0. 93 0. 04 81. 1 (24. 7) 65. 6 (27. 6) 0. 01 0. 60 68. 6 (18. 0) 59. 8 (22. 0) 0. 08 0. 44 12 m ont hs 77. 1 (25. 5) 72. 6 (25. 9) 0. 53 0. 17 63. 2 (37. 6) 60. 0 (44. 3) 0. 97 0. 08 75. 5 (24. 8) 63. 9 (30. 3) 0. 13 0. 42 62. 9 (22. 7) 55. 6 (23. 6) 0. 15 0. 32 V al ues ( ex cep t p -v al ue s and E S) r ep res en t t he m ea n (S D ) s co re . aSF -36 s ubs ca le s h ad a r an ge of 0 -1 00. H ig he r sc or es indi ca te d be tt er he al th -r el ate d q ua lity o f l ife ( H R Q L ). b Tes t o f bet w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= e ff ec t s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = la rg e ef fe ct )
62 I EMMAOHLSSON-NEVO Colorectalcancer
Table 5. SF-36 physical subscale scoresa of patients in the intervention (PEP n=47) and control (CON n=39) groups
Physical Function Role-Physical Bodily Pain General Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
Baseline 67.0 (24.2) (2.9) 66.5 0.85 0.04 (36.5) 28.7 (38.8) 25.8 0.62 0.07 (27.0) 65.2 (30.5) 61.0 0.51 0.15 (18.5) 67.1 (18.4) 59.1 0.05 0.43 1 month 72.2 (25.7) (24.8) 73.7 0.90 0.06 (44.2) 54.5 (44.1) 47.3 0.60 0.16 (29.9) 75.6 (20.1) 64.2 0.07 0.38 (19.4) 64.8 (18.9) 54.8 0.02 0.52 6 months 75.7 (24.9) (23.3) 74.8 0.57 0.04 (41.3) 62.8 (40.8) 61.0 0.93 0.04 (24.7) 81.1 (27.6) 65.6 0.01 0.60 (18.0) 68.6 (22.0) 59.8 0.08 0.44 12 months 77.1 (25.5) (25.9) 72.6 0.53 0.17 (37.6) 63.2 (44.3) 60.0 0.97 0.08 (24.8) 75.5 (30.3) 63.9 0.13 0.42 (22.7) 62.9 (23.6) 55.6 0.15 0.32
Values (except p-values and ES) represent the mean (SD) score.
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life (HRQL). b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect)
E MM A O HL SS O N -N E VO C ol or ec ta lc anc er I 63 Ta bl e 6 a. SF -3 6 su m m ary sc ore s ( PC S, M C S) a ne xt -of -ki n i n t he int er ve nt io n ( PE P) a nd C ont rol g rou ps PCS M CS PEP CO N p b ES c PEP CO N p ES B as elin e 47. 9 ( 11. 6) 49. 9 ( 11. 5) 0. 37 0. 17 46. 0 ( 13. 22) 41. 9 ( 15. 7) 0. 30 0. 28 1 m ont h 46. 8 ( 11. 7) 48. 5 ( 10. 5) 0. 80 0. 15 46. 4 ( 12. 8) 47. 9 ( 13. 6) 0. 37 0. 11 6 m ont hs 45. 7 ( 11. 2) 48. 4 ( 9. 9) 0. 44 0. 22 47. 5 ( 13. 9) 49. 8 ( 12. 8) 0. 51 0. 17 12 m ont hs 48. 4 ( 9. 1) 47. 3 ( 11. 9) 0. 97 0. 10 49. 2 ( 12. 5. ) 49. 3 ( 14. 31) 0. 52 0. 00 V al ues ( ex cep t p -v al ue s an d ES ) r ep res en t t he m ea n (S D ) s co re . PC S=Phy si ca l C om pone nt S cor e, M C S= M ent al c om pone nt S cor e aT he m ea n sum m ar y s cor e for t he g ene ra l S w edi sh popu la ti on w as 50 ; l ow er s cor es ind ic at e w or se ph ys ic al or m ent al he al th c om pa re d to the g ene ra l popul at ion b Tes t o f b et w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= ef fect s iz e (C oh en ’s ef fe ct s ize inde x ( 0. 2 t o <0 . 5 = s m al l, 0 .5 t o <0. 8 = m ode ra te , a nd >0 .8 = la rg e ef fe ct ) d Te st o f w ith in -g roup c ha ng e f ro m ba se line t o fol low -up ( W ilc oxon S ig ne d-ra nk te st)
EMMAOHLSSON-NEVO Colorectalcancer I 63
Table 6a. SF-36 summary scores (PCS, MCS)a next-of-kin in the intervention (PEP) and Control groups
PCS MCS
PEP CON pb ESc PEP CON p ES
Baseline 47.9 (11.6) 49.9 (11.5) 0.37 0.17 46.0 (13.22) 41.9 (15.7) 0.30 0.28
1 month 46.8 (11.7) 48.5 (10.5) 0.80 0.15 46.4 (12.8) 47.9 (13.6) 0.37 0.11
6 months 45.7 (11.2) 48.4 (9.9) 0.44 0.22 47.5 (13.9) 49.8 (12.8) 0.51 0.17
12 months 48.4 (9.1) 47.3 (11.9) 0.97 0.10 49.2 (12.5.) 49.3 (14.31) 0.52 0.00
Values (except p-values and ES) represent the mean (SD) score. PCS=Physical Component Score, MCS= Mental component Score
aThe mean summary score for the general Swedish population was 50; lower scores indicate worse physical or mental health compared to the general population
b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
64 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er Ta bl e 6b . SF -3 6 su m m ary sc ore s ( PC S, M C S) a ne xt -of -ki n i n t he int er ve nt io n ( PE P) a nd C ont rol g rou ps PCS M CS PEP CO N p b ES c PEP CO N p ES C ha ng e 0-1 m ont h -0. 16 ( 7. 5) -0. 42 ( 5. 1) 0. 89 0. 04 0. 91 ( 9. 1) 5. 39 ( 11. 2) 0. 12 0. 43 p-val ue d 0. 80 0. 79 0. 31 0. 05 SRM e 0. 02 0. 08 0.1 0. 48 0-6 m ont hs -2. 13 ( 9. 0) -1. 6 ( 6. 52) 0. 83 0. 07 2. 13 ( 10. 3) 5. 88 ( 13. 5) 0. 29 0. 31 p-val ue 0. 09 0. 62 0. 12 0. 11 SRM 0. 24 0. 25 0. 21 0. 44 0-12 m ont hs -0. 8 ( 10. 7) -2. 76 ( 7. 7) 0. 50 0. 10 2. 98 ( 10. 9) 6. 78 ( 11. 4) 0. 27 0. 34 p-val ue 0. 60 0. 03 0. 12 <0. 01 SRM 0. 07 0. 10 0. 27 0. 59 V al ues ( ex cep t p -v al ue s, E S and S R M ) re pre se nt t he m ea n ( SD ) sc ore . PC S=Phy si ca l C om pone nt S cor e, M C S= M ent al c om pone nt S cor e aT he m ea n sum m ar y s cor e for t he g ene ra l S w edi sh popu la ti on w as 50 ; l ow er s cor es ind ic at e w or se ph ys ic al or m ent al he al th c om pa re d to t he g ene ra l popul at ion b Tes t o f b et w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= ef fect s ize ( C oh en ’s ef fect s iz e i nd ex ( 0. 2 t o <0 . 5 = s m al l, 0. 5 to <0. 8 = m ode ra te , a nd >0 .8 = la rg e ef fe ct ) d Te st o f w ith in -g roup c ha ng e f ro m ba se line t o fol low -up ( W ilc oxon S ig ne d-ra nk te st) e SR M = St and ar di ze d R es pons e M ea n
64 I EMMAOHLSSON-NEVO Colorectalcancer
Table 6b. SF-36 summary scores (PCS, MCS)a next-of-kin in the intervention (PEP) and Control groups
PCS MCS
PEP CON pb ESc PEP CON p ES
Change 0-1 month -0.16 (7.5) -0.42 (5.1) 0.89 0.04 0.91 (9.1) 5.39 (11.2) 0.12 0.43 p-valued 0.80 0.79 0.31 0.05 SRMe 0.02 0.08 0.1 0.48 0-6 months -2.13 (9.0) -1.6 (6.52) 0.83 0.07 2.13 (10.3) 5.88 (13.5) 0.29 0.31 p-value 0.09 0.62 0.12 0.11 SRM 0.24 0.25 0.21 0.44 0-12 months -0.8 (10.7) -2.76 (7.7) 0.50 0.10 2.98 (10.9) 6.78 (11.4) 0.27 0.34 p-value 0.60 0.03 0.12 <0.01 SRM 0.07 0.10 0.27 0.59
Values (except p-values, ES and SRM) represent the mean (SD) score. PCS=Physical Component Score, MCS= Mental component Score aThe mean summary score for the general Swedish population was 50; lower scores indicate worse physical or mental health compared to the general population
b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
e SRM= Standardized Response Mean
E MM A O HL SS O N -N E VO C ol or ec ta lc anc er I 65 Ta bl e 7. M en ta l w ellb ein g pa ti ent s, ne xt -of -ki n a nd gen er al S w ed ish nor m G en er al S w ed is h nor m Pa ti ent Ne xt -of -ki n Pat vs . ne xt -of -ki n Pat vs . Sw edi sh nor m Ne xt -of -ki n vs. S w ed ish nor m n M ea n ( sd) n M ea n ( sd) n M ea n ( sd) p-val ue p-val ue p-val ue M ACL 502 3. 17 ( 0. 40) 86 2. 99 ( 0. 54) 64 3. 04 ( 0. 59) 0. 59 <0. 00 1 0. 021 A ct iv it y 502 3. 21 ( 0. 48) 86 2. 89 ( 0. 56) 64 3. 10 ( 0. 59) 0. 006 <0. 00 1 0. 090 C al mne ss 502 3. 05 ( 0. 61) 86 3. 07 ( 0. 62) 64 2. 90 ( 0. 69) 0. 11 0. 779 0. 068 Pl ea sa nt ne ss 502 3. 25 ( 0. 53) 86 3. 09 ( 0. 60) 64 3. 06 ( 0. 65) 0. 80 0. 011 <0. 00 1 HA D -A 624 4. 51 (3. 73) 85 4. 52 ( 3. 8) 63 6. 35 ( 4. 65) 0. 018 0. 982 <0. 00 1 HA D -D 624 3. 98 ( 3. 46) 85 4. 18 ( 3. 01 63 3. 99 ( 3. 79) 0. 75 0. 612 0. 983 M AC L (M oo d ad je ct iv e ch eck lis t) = O ve ra ll M ood , O ve ra ll M ood, A ct iv at io n, C al m ne ss , P le as an tn es s: Sc al e r an ge 1 -4; h ig h s cor e r epr es ent be tt er m ood . H AD = H os pi ta l a nxi et y a nd de pr es si on s ca le , A= an xie ty , D =de pr es si on ; Sc al e r an ge 0 -21 (h ig h sco re r ep res en t sy mp to ms )
EMMAOHLSSON-NEVO Colorectalcancer I 65 Table 7. Mental wellbeing patients, next-of-kin and general Swedish norm
General Swedish
norm Patient Next-of-kin next-of-kin Pat vs. Swedish Pat vs.
norm
Next-of-kin vs. Swedish
norm
n Mean (sd) n Mean (sd) n Mean (sd) p-value p-value p-value
MACL 502 3.17 (0.40) 86 2.99 (0.54) 64 3.04 (0.59) 0.59 <0.001 0.021 Activity 502 3.21 (0.48) 86 2.89 (0.56) 64 3.10 (0.59) 0.006 <0.001 0.090 Calmness 502 3.05 (0.61) 86 3.07 (0.62) 64 2.90 (0.69) 0.11 0.779 0.068 Pleasantness 502 3.25 (0.53) 86 3.09 (0.60) 64 3.06 (0.65) 0.80 0.011 <0.001 HAD-A 624 4.51 (3.73) 85 4.52 (3.8) 63 6.35 (4.65) 0.018 0.982 <0.001 HAD-D 624 3.98 (3.46) 85 4.18 (3.01 63 3.99 (3.79) 0.75 0.612 0.983
MACL (Mood adjective checklist) =Overall Mood,
Overall Mood, Activation, Calmness, Pleasantness: Scale range 1-4; high score represent better mood.
EMMAOHLSSON-NEVO Colorectalcancer I 65 Table 7. Mental wellbeing patients, next-of-kin and general Swedish norm
General Swedish
norm Patient Next-of-kin next-of-kin Pat vs. Swedish Pat vs.
norm
Next-of-kin vs. Swedish
norm
n Mean (sd) n Mean (sd) n Mean (sd) p-value p-value p-value
MACL 502 3.17 (0.40) 86 2.99 (0.54) 64 3.04 (0.59) 0.59 <0.001 0.021 Activity 502 3.21 (0.48) 86 2.89 (0.56) 64 3.10 (0.59) 0.006 <0.001 0.090 Calmness 502 3.05 (0.61) 86 3.07 (0.62) 64 2.90 (0.69) 0.11 0.779 0.068 Pleasantness 502 3.25 (0.53) 86 3.09 (0.60) 64 3.06 (0.65) 0.80 0.011 <0.001 HAD-A 624 4.51 (3.73) 85 4.52 (3.8) 63 6.35 (4.65) 0.018 0.982 <0.001 HAD-D 624 3.98 (3.46) 85 4.18 (3.01 63 3.99 (3.79) 0.75 0.612 0.983
MACL (Mood adjective checklist) =Overall Mood,
Overall Mood, Activation, Calmness, Pleasantness: Scale range 1-4; high score represent better mood.
HAD= Hospital anxiety and depression scale, A=anxiety, D=depression; Scale range 0-21(high score represent symptoms)
66 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er T abl e 8. M A C L s co re s, m en ta l w ellb ein g of pa ti ent s in int er ve nt ion s (PE P) a nd c ont rol g roup s ( cont rol ) B ase lin e 1 m ont h 6 m ont h 12 m ont h P EP n=47 C on tr ol n=39 p P EP n=44 C on tr ol n=36 p P EP n=43 C on tr ol n=28 p P EP n=38 C on tr ol n=28 p O VE R AL L M OOD B M m ( SD ) 2. 99 ( 0. 54) Me an (S D ) 3. 04( 0. 56) 2. 94( 0. 51) 0. 40 3, 14( 0. 53) 2. 97( 0. 50) 0. 14 3, 11 (0. 35) 3. 02( 0. 59) 0. 51 3. 04( 0. 70) 2. 95( 0. 65) 0. 62 > B Mm [% ] 8/ 47[ 60] 19/ 39[ 49] 0. 39+ 32/ 44[ 73] 17/ 36[ 47] 0. 02+ 29/ 43[ 67] 16/ 28[ 57] 0. 45+ 23/ 38[ 60] 15/ 28[ 54] 0. 62+ A cti va ti on B M a ( SD ) 2, 86 ( 0. 56) M ean ( SD ) 2. 89( 0. 60) 2. 83( 0. 52) 0. 65 2. 98( 0. 59) 2. 88( 0. 56) 0. 40 2. 98( 0. 59) 2. 87( 0. 62) 0. 45 2. 93( 0. 74) 2. 84( 0. 72) 0. 65 >t ha n B Ma [ % ] 28/ 47[ 59] 20/ 39[ 51] 0. 51+ 31/ 44[ 70] 20/ 36[ 56] 0. 24+ 30/ 43[ 70] 17/ 28[ 61] 0. 45+ 25/ 38[ 66] 17/ 28[ 43] 0. 80+ C al m ne ss M ea n B M c 3. 08 Me an (S D ) 3, 13( 0. 63) 3, 02( 0. 63) 0. 42£ 3, 30( 0. 58 3, 11( 0. 60) 0. 11£ 3, 18( 0. 56) 3, 17( 0. 63) 0. 95£ 3, 14( 0. 68) 3, 04( 0. 63) 0. 44£ >t ha n B M c [% ] 29/ 47[ 62] 19/ 39[ 49] 0. 28+ 35/ 44[ 80] 20/ 36[ 56] 0. 03+ 28/ 43[ 65] 17/ 28[ 61] 0. 80+ 23/ 38[ 60] 15/ 28[ 54] 0. 62+ Pl ea sa nt ne ss M ea n B M -p (S D ) 3. 09( 0. 60) M ean ( SD ) 3. 16( 0. 63) 3. 02( 0. 53) 0. 26 3. 24( 0. 57) 2. 99( 0. 56) 0. 04£ 3. 22( 0. 55) 3. 11( 0. 65) 0. 41 3. 1( 0. 74) 3. 03( 0. 67) 0. 65 >B M p 3. 09[ % ] 30/ 47[ 64] 20/ 39[ 51] 0. 28+ 31/ 44[ 70] 14/ 36[ 39] 0. 007+ 26/ 43[ 60] 16/ 28[ 57] 0. 81+ 21/ 38[ 55] 13/ 28[ 46] 0. 62+ O ve ra ll M ood ( A ct iv at ion , C al m ne ss , Pl ea sa nt ne ss ): S ca le r an ge 1 -4 ; h ig h s co re r ep res en t b et ter mo od . B M = B as el in e m ea n ( bot h i nt er ve nt ion g roup a nd c ont rol g roup) m = ov er al l m ood, a = ac ti va ti on , c = c al m ne ss p= pl ea sa nt ne ss [% ] = p er cen ta ge w it hi n t he int er ve nt ion g roup r es p. c ont rol g roup £= M ann -W hi tn ey te st += fi sh er ’s e xa ct te st
66 I EMMAOHLSSON-NEVO Colorectalcancer
Table 8. MACL scores, mental wellbeing of patients in interventions (PEP) and control groups (control)
Baseline 1 month 6 month 12 month
PEP
n=47 Control n=39 p PEP n=44 Control n=36 p n=43 PEP Control n=28 p n=38 PEP Control n=28 p
OVER ALL MOOD BMm (SD) 2.99 (0.54) Mean (SD) 3.04(0.56) 2.94(0.51) 0.40 3,14(0.53) 2.97(0.50) 0.14 3,11 (0.35) 3.02(0.59) 0.51 3.04(0.70) 2.95(0.65) 0.62 >BMm [%] 8/47[60] 19/39[49] 0.39+ 32/44[73] 17/36[47] 0.02+ 29/43[67] 16/28[57] 0.45+ 23/38[60] 15/28[54] 0.62+ Activation BMa (SD) 2,86 (0.56) Mean (SD) 2.89(0.60) 2.83(0.52) 0.65 2.98(0.59) 2.88(0.56) 0.40 2.98(0.59) 2.87(0.62) 0.45 2.93(0.74) 2.84(0.72) 0.65 >than BMa [%] 28/47[59] 20/39[51] 0.51+ 31/44[70] 20/36[56] 0.24+ 30/43[70] 17/28[61] 0.45+ 25/38[66] 17/28[43] 0.80+ Calmness Mean BMc 3.08 Mean (SD) 3,13(0.63) 3,02(0.63) 0.42£ 3,30(0.58 3,11(0.60) 0.11£ 3,18(0.56) 3,17(0.63) 0.95£ 3,14(0.68) 3,04(0.63) 0.44£ >than BMc [%] 29/47[62] 19/39[49] 0.28+ 35/44[80] 20/36[56] 0.03+ 28/43[65] 17/28[61] 0.80+ 23/38[60] 15/28[54] 0.62+ Pleasantness Mean BM-p (SD) 3.09(0.60) Mean (SD) 3.16(0.63) 3.02(0.53) 0.26 3.24(0.57) 2.99(0.56) 0.04£ 3.22(0.55) 3.11(0.65) 0.41 3.1(0.74) 3.03(0.67) 0.65 >BMp 3.09[%] 30/47[64] 20/39[51] 0.28+ 31/44[70] 14/36[39] 0.007+ 26/43[60] 16/28[57] 0.81+ 21/38[55] 13/28[46] 0.62+
Overall Mood (Activation, Calmness, Pleasantness): Scale range 1-4; high score represent better mood. BM= Baseline mean (both intervention group and control group)
m= overall mood, a= activation, c= calmness p= pleasantness [%] = percentage within the intervention group resp. control group £= Mann-Whitney test
+=fisher’s exact test
EMMAOHLSSON-NEVO Colorectalcancer I 67
Table 9. SF-36 mental subscale scoresa of patients in the intervention (PEP, n=47) and control (CON n=39)
Vitality Social Functioning Role-Emotional Mental Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
Baseline 52.9 (22.3) (22.3) 52.1 0.88 0.04 (21.2) 74.7 (24.1) 61.2 <0.01 0.60 (41.3) 55.3 (45.0) 56.7 0.81 0.03 (19.2) 76.4 (19.9) 72.2 0.32 0.21 1 m 60.6 (26.1) (22.7) 54.0 0.24 0.27 (27.3) 80.1 (24.4) 66.1 <0.00 0.54 (40.8) 73.6 (43.8) 60.8 0.11 0.15 (18.0) 80.7 (18.6) 71.5 0.03 0.50 6 m 69.5 (22.2) (25.4) 63.4 0.29 0.26 (20.1) 85.2 (22.1) 73.7 0.02 0.55 (37.7) 70.6 (38.2) 72.8 0.84 0.06 (19.8) 81.5 (19.2) 78.1 0.48 0.17 12 m 62.5 (26.8) (27.7) 55.3 0.28 0.26 (21.5) 83.6 (26.3) 72.5 0.06 0.46 (40.6) 69.3 (40.7) 74.4 0.55 0.13 (21.8) 78.5 (20.8) 74.9 0.50 0.17
Values (except p-values and ES) represent the mean (SD) score.
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life (HRQL) b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
m= month(s) E MM A O HL SS O N -N E VO C ol or ec ta lc anc er I 67 Ta bl e 9. S F-36 m ent al s ubs ca le s cor es a of pa ti ent s i n t he int er ve nt ion ( PE P, n =47) a nd c ont rol ( C O N n =39) V it alit y Soc ia l Func ti oni ng Ro le -E m ot iona l Me nta l H ea lth PEP C ON p b ES c PEP C ON p ES PEP C ON p ES PEP C ON p ES B as elin e 52. 9 (22. 3) 52. 1 (22. 3) 0. 88 0. 04 74. 7 (21. 2) 61. 2 (24. 1) <0. 01 0. 60 55. 3 (41. 3) 56. 7 (45. 0) 0. 81 0. 03 76. 4 (19. 2) 72. 2 (19. 9) 0. 32 0. 21 1 m 60. 6 (26. 1) 54. 0 (22. 7) 0. 24 0. 27 80. 1 (27. 3) 66. 1 (24. 4) <0. 00 0. 54 73. 6 (40. 8) 60. 8 (43. 8) 0. 11 0. 15 80. 7 (18. 0) 71. 5 (18. 6) 0. 03 0. 50 6 m 69. 5 (22. 2) 63. 4 (25. 4) 0. 29 0. 26 85. 2 (20. 1) 73. 7 (22. 1) 0. 02 0. 55 70. 6 (37. 7) 72. 8 (38. 2) 0. 84 0. 06 81. 5 (19. 8) 78. 1 (19. 2) 0. 48 0. 17 12 m 62. 5 (26. 8) 55. 3 (27. 7) 0. 28 0. 26 83. 6 (21. 5) 72. 5 (26. 3) 0. 06 0. 46 69. 3 (40. 6) 74. 4 (40. 7) 0. 55 0. 13 78. 5 (21. 8) 74. 9 (20. 8) 0. 50 0. 17 V al ues ( ex cep t p -v al ue s a nd E S) r ep res en t t he m ea n ( SD ) s co re . aSF -36 s ubs ca le s h ad a r an ge of 0 -1 00. H ig he r sc or es indi ca te d be tt er he al th -r el ate d q ua lity o f l ife ( H R Q L ) b Tes t o f bet w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= ef fect s ize ( C oh en ’s e ff ec t s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = la rg e ef fe ct ) d Te st o f w ith in -g roup cha ng e f rom ba se lin e to f ol low -up (W ilc oxon S ig ne d-ra nk te st) m = m ont h( s)
EMMAOHLSSON-NEVO Colorectalcancer I 67
Table 9. SF-36 mental subscale scoresa of patients in the intervention (PEP, n=47) and control (CON n=39)
Vitality Social Functioning Role-Emotional Mental Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
Baseline 52.9 (22.3) (22.3) 52.1 0.88 0.04 (21.2) 74.7 (24.1) 61.2 <0.01 0.60 (41.3) 55.3 (45.0) 56.7 0.81 0.03 (19.2) 76.4 (19.9) 72.2 0.32 0.21 1 m 60.6 (26.1) (22.7) 54.0 0.24 0.27 (27.3) 80.1 (24.4) 66.1 <0.00 0.54 (40.8) 73.6 (43.8) 60.8 0.11 0.15 (18.0) 80.7 (18.6) 71.5 0.03 0.50 6 m 69.5 (22.2) (25.4) 63.4 0.29 0.26 (20.1) 85.2 (22.1) 73.7 0.02 0.55 (37.7) 70.6 (38.2) 72.8 0.84 0.06 (19.8) 81.5 (19.2) 78.1 0.48 0.17 12 m 62.5 (26.8) (27.7) 55.3 0.28 0.26 (21.5) 83.6 (26.3) 72.5 0.06 0.46 (40.6) 69.3 (40.7) 74.4 0.55 0.13 (21.8) 78.5 (20.8) 74.9 0.50 0.17
Values (except p-values and ES) represent the mean (SD) score.
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life (HRQL) b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
m= month(s) 68 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er T abl e 1 0. C ha ng es in SF -3 6 phy si ca l s ubs ca le s co re s a of pa ti ent s i n t he int er ve nt io n ( PE P n= 47) a nd c ont rol ( C O N n= 39) Phy si ca l Func ti on Ro le -Phy si ca l B odi ly Pa in G en er al H ea lt h PEP C ON p b ES c PEP C ON p ES PEP C ON p ES PEP C ON p ES 0-1 m 5. 2 (16. 5) 4. 4 (26. 7) 0. 67 0. 04 26. 8 (44. 5) 22. 0 (48. 0) 0. 75 0. 10 11. 8 (29. 3) 2. 68 (28. 0) 0. 13 0. 32 -1. 4 (17. 2) -6. 0 (18. 9) 0. 22 0. 25 p d 0. 04 0. 17 <0. 00 0. 02 0. 02 0. 57 0. 78 0. 15 SRM e 0. 31 0. 16 0. 60 0. 46 0. 40 0. 61 0. 08 0. 32 0-6 m 7. 5 (13. 7) 6. 6 (24. 2) 0. 54 0. 04 34. 8 (50. 9) 34. 8 (50. 8) 0. 99 0. 00 16. 7 (30. 5) 4. 3 (35. 2) 0. 12 0. 37 2. 7 (13. 9) 0. 1 (18. 03) 0. 38 0. 11 p <0. 00 0. 16 <0. 00 <0. 00 <0. 00 0. 72 0. 16 0. 97 SRM 0. 55 0. 27 0. 68 0. 69 0. 54 0. 12 0. 19 0.0 0-12 m 6. 0 (19. 8) 4. 9 (28. 3) 0. 38 0. 05 34. 7 (49. 0) 33. 9 (50. 0) 0. 69 0. 16 10. 5 (32. 4) 2. 6 (30. 3) 0. 26 0. 13 -3. 1 (21. 3) -4. 2 (17. 1) 0. 46 0. 06 p 0. 02 0. 40 <0. 00 <0. 00 0. 06 0. 66 0. 72 0. 18 SRM 0. 30 0. 17 0. 71 0. 67 0. 32 0. 09 0. 15 0. 22 V al ues ( ex cep t p -v al ue s, E S and SR M ) r epr es ent t he m ea n (S D ) s cor e. aSF -36 s ub sc al es h ad a r an ge o f 0 -1 00. H ig he r sc or es indi ca te d be tt er he al th -r el ate d q ua lity o f l ife ( H R Q L ) b Tes t o f bet w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= e ff ec t s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = l ar ge e ff ec t) d Te st o f w ith in -g roup cha ng e f rom ba se lin e to f ol low -up (W ilc oxon S ig ne d-ra nk te st) e SR M = S ta nda rd iz ed R es pons e M ea n m = m ont h( s)
68 I EMMAOHLSSON-NEVO Colorectalcancer
Table 10. Changes in SF-36 physical subscale scoresa of patients in the intervention (PEP n=47) and control (CON n=39)
Physical Function Role-Physical Bodily Pain General Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
0-1 m 5.2 (16.5) (26.7) 4.4 0.67 0.04 (44.5) 26.8 (48.0) 22.0 0.75 0.10 (29.3) 11.8 (28.0) 2.68 0.13 0.32 (17.2) -1.4 (18.9) -6.0 0.22 0.25 pd 0.04 0.17 <0.00 0.02 0.02 0.57 0.78 0.15 SRMe 0.31 0.16 0.60 0.46 0.40 0.61 0.08 0.32 0-6 m 7.5 (13.7) (24.2) 6.6 0.54 0.04 (50.9) 34.8 (50.8) 34.8 0.99 0.00 (30.5) 16.7 (35.2) 4.3 0.12 0.37 (13.9) 2.7 (18.03) 0.1 0.38 0.11 p <0.00 0.16 <0.00 <0.00 <0.00 0.72 0.16 0.97 SRM 0.55 0.27 0.68 0.69 0.54 0.12 0.19 0.0 0-12 m 6.0 (19.8) (28.3) 4.9 0.38 0.05 (49.0) 34.7 (50.0) 33.9 0.69 0.16 (32.4) 10.5 (30.3) 2.6 0.26 0.13 (21.3) -3.1 (17.1) -4.2 0.46 0.06 p 0.02 0.40 <0.00 <0.00 0.06 0.66 0.72 0.18 SRM 0.30 0.17 0.71 0.67 0.32 0.09 0.15 0.22
Values (except p-values, ES and SRM) represent the mean (SD) score.
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life (HRQL) b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
e SRM= Standardized Response Mean m= month(s)
EMMAOHLSSON-NEVO Colorectalcancer I 69
Table 11. Changes in SF-36 mental subscale scoresa of patients in the intervention (PEP, n=47) and control (CON n=39) group
Vitality Social Functioning Role-Emotional Mental Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
0-1 m 9.0 (22.0) (20.3) -0.5 0.07 0.40 (32.3) 5.6 (24.1) 5.4 0.79 0.01 (55.7) 16.7 (49.4) 5.05 0.14 0.22 (20.1) 4.7 (16.3) -1.1 0.21 0.19 p-valued 0.02 0.90 0.19 0.22 0.09 0.53 0.12 0.98 SRMe 0.41 0.02 0.17 0.22 0.30 0.10 0.23 0.07 0-6 m 17.0 (25.4) (19.2) 12.7 0.48 0.19 (25.5) 10.7 (26.1) 12.5 0.72 0.07 (43.6) 10.8 (54.1) 19.8 0.43 0.18 (17.5) 6.2 (14.2) 5.5 0.92 0.04 p-value 0.00 0.00 0.02 0.02 0.09 0.11 0.02 0.04 SRM 0.67 0.66 0.42 0.48 0.25 0.37 0.35 0.39 0-12m 9.0 (25.1) (23.1) 6.1 0.57 0.12 (22.0) 9.1 (25.0) 11.7 0.86 0.11 (50.1) 15.7 (53.5) 23.0 0.60 0.34 (13.3) 3.1 (13.8) 3.9 0.95 0.05 p-value 0.04 0.25 0.00 0.02 0.002 0.06 0.13 0.13 SRM 0.36 0.26 0.42 0.47 0.35 0.43 0.23 0.28
Values (except p-values, ES and SRM) represent the mean (SD) score.
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life (HRQL) b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
e SRM= Standardized Response Mean
E MM A O HL SS O N -N E VO C ol or ec ta lc anc er I 69 Ta bl e 11 . C ha ng es in S F-36 m ent al s ubs ca le s cor es a of p at ie nt s i n t he int er ve nt ion ( PE P, n= 47) a nd c ont rol ( C O N n= 39) g ro up V it alit y Soc ia l Func ti oni ng Ro le -E m ot iona l Me nta l H ea lth PEP C ON p b ES c PEP C ON p ES PEP C ON p ES PEP C ON p ES 0-1 m 9. 0 (22. 0) -0. 5 (20. 3) 0. 07 0. 40 5. 6 (32. 3) 5. 4 (24. 1) 0. 79 0. 01 16. 7 (55. 7) 5. 05 (49. 4) 0. 14 0. 22 4. 7 (20. 1) -1. 1 (16. 3) 0. 21 0. 19 p-val ue d 0. 02 0. 90 0. 19 0. 22 0. 09 0. 53 0. 12 0. 98 SRM e 0. 41 0. 02 0. 17 0. 22 0. 30 0. 10 0. 23 0. 07 0-6 m 17. 0 (25. 4) 12. 7 (19. 2) 0. 48 0. 19 10. 7 (25. 5) 12. 5 (26. 1) 0. 72 0. 07 10. 8 (43. 6) 19. 8 (54. 1) 0. 43 0. 18 6. 2 (17. 5) 5. 5 (14. 2) 0. 92 0. 04 p-val ue 0. 00 0. 00 0. 02 0. 02 0. 09 0. 11 0. 02 0. 04 SRM 0. 67 0. 66 0. 42 0. 48 0. 25 0. 37 0. 35 0. 39 0-12m 9. 0 (25. 1) 6. 1 (23. 1) 0. 57 0. 12 9. 1 (22. 0) 11. 7 (25. 0) 0. 86 0. 11 15. 7 (50. 1) 23. 0 (53. 5) 0. 60 0. 34 3. 1 (13. 3) 3. 9 (13. 8) 0. 95 0. 05 p-val ue 0. 04 0. 25 0. 00 0. 02 0. 002 0. 06 0. 13 0. 13 SRM 0. 36 0. 26 0. 42 0. 47 0. 35 0. 43 0. 23 0. 28 V al ues ( ex cep t p -v al ue s, E S and SR M ) r epr es ent t he m ea n (S D ) s cor e. aSF -36 s ub sc al es h ad a r an ge o f 0 -1 00. H ig he r sc or es indi ca te d be tt er he al th -r el ate d q ua lity o f l ife ( H R Q L ) b Tes t o f bet w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= e ff ec t s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = l ar ge e ff ec t) d Te st o f w ith in -g roup cha ng e f rom ba se lin e to f ol low -up ( W ilc ox on S ig ne d-ra nk te st) e SR M = S ta nd ar di ze d R es pons e M ea n
EMMAOHLSSON-NEVO Colorectalcancer I 69
Table 11. Changes in SF-36 mental subscale scoresa of patients in the intervention (PEP, n=47) and control (CON n=39) group
Vitality Social Functioning Role-Emotional Mental Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
0-1 m 9.0 (22.0) (20.3) -0.5 0.07 0.40 (32.3) 5.6 (24.1) 5.4 0.79 0.01 (55.7) 16.7 (49.4) 5.05 0.14 0.22 (20.1) 4.7 (16.3) -1.1 0.21 0.19 p-valued 0.02 0.90 0.19 0.22 0.09 0.53 0.12 0.98 SRMe 0.41 0.02 0.17 0.22 0.30 0.10 0.23 0.07 0-6 m 17.0 (25.4) (19.2) 12.7 0.48 0.19 (25.5) 10.7 (26.1) 12.5 0.72 0.07 (43.6) 10.8 (54.1) 19.8 0.43 0.18 (17.5) 6.2 (14.2) 5.5 0.92 0.04 p-value 0.00 0.00 0.02 0.02 0.09 0.11 0.02 0.04 SRM 0.67 0.66 0.42 0.48 0.25 0.37 0.35 0.39 0-12m 9.0 (25.1) (23.1) 6.1 0.57 0.12 (22.0) 9.1 (25.0) 11.7 0.86 0.11 (50.1) 15.7 (53.5) 23.0 0.60 0.34 (13.3) 3.1 (13.8) 3.9 0.95 0.05 p-value 0.04 0.25 0.00 0.02 0.002 0.06 0.13 0.13 SRM 0.36 0.26 0.42 0.47 0.35 0.43 0.23 0.28
Values (except p-values, ES and SRM) represent the mean (SD) score.
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life (HRQL) b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
e SRM= Standardized Response Mean
70 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er T abl e 1 2. M en ta l w ellb ein g (MA C L )i n ne xt -of -ki n B ase lin e 1 m ont h 6 m ont h 12 m ont h P EP n=39 C on tr ol n=25 p P EP n=37 C on tr ol n=23 p P EP n=36 C on tr ol n=18 p P EP n=33 C on tr ol n=22 p O VE RAL L M OO D B M m ( SD ) 3. 04( 0. 60) Me an (S D ) 3. 07( 0. 65 3. 00( 0. 50) 0. 66 2. 95( 0. 71) 3. 03( 0. 49) 0. 64 2. 92( 0. 71) 3. 13( 0. 48) 0. 28 3. 08( 0. 63) 3. 11( 0. 53) 0. 83 >B M -m [% ] 25/ 39[ 64] 17/ 25[ 68] 0. 79+ 21/ 37[ 57] 15/ 22[ 68] 0. 42+ 19/ 35[ 54] 13/ 18[ 72] 0. 25+ 23/ 33[ 70] 14/ 22[ 64] 0. 77+ A cti va ti on BM -a ( SD ) 3. 10( 0. 59) m ea n ( SD ) 3. 12( 0. 67 3. 09( 0. 45) 0. 90 2. 97( 0. 69) 3. 11( 0. 51) 0. 58 2. 95( 0. 72) 3. 17( 0. 43) 0. 22 3. 12( 0. 58) 3. 13( 0. 52) 0. 95 > t ha n B M -a [% ] 24/ 39[ 61] 15/ 25[ 60] 0. 90+ 22/ 37[ 60] 15/ 22[ 68] 0. 60+ 22/ 36[ 61] 13718[ 72] 0. 42+ 20/ 33[ 61] 14/ 22[ 62] 0. 81+ C al m ne ss M ea n B M -c 2. 90( 0. 69 Me an (S D ) 2. 95( 0. 75) 2. 82( 0. 59) 0. 45 2. 87( 0. 86) 2. 91( 0. 58) 0. 81 2. 83( 0. 81) 3. 04( 0. 81) 0. 33 2. 95( 0. 73) 3. 01( 0. 67) 0. 77 > t ha n B M -c [% ] 25/ 40[ 62] 13/ 25[ 52] 0. 40+ 21/ 37[ 57] 11/ 23[ 48] 0. 78+ 22/ 38[ 58] 12/ 18[ 67] 0. 53+ 21/ 33[ 64] 14/ 22[ 63] 1. 0+ Pl ea sa nt ne ss M ea n B M -p (S D ) 3. 06( 0. 66) M ean ( SD ) 3. 09( 0. 69) 3. 02( 0. 58) 0. 64 3. 0( 0. 73) 3. 01( 0. 52) 0. 93 2. 95( 0. 72) 3. 15( 0. 53) 0. 36 3. 12( 0. 70) 3. 17( 0. 56) 0. 77 > t ha n B M -p [% ] 23/ 39[ 59] 15/ 25[ 60] 1. 0+ 23/ 37[ 62] 13/ 22[ 56] 0. 59+ 20/ 36[ 55] 13/ 18[ 72] 0. 37+ 22/ 33[ 67] 15/ 22[ 68] 1. 0+ O ve ra ll M ood (A ct iv at io n, C al m ne ss, P le asa nt ne ss) : ra ng e 1 -4; h ig h sc or e r epr es ent be tt er m ood, B M = B as el in e m ea n ( bot h PE P. g ro up and c ont rol g roup) m = ov er al l m ood, a = a ct iv at ion , c = ca lm ne ss p = pl ea sa nt ne ss [% ] = pe rc ent ag e w it hi n the int er ve nt ion g roup r es p. c on tr ol g roup £= M ann -W hi tn ey te st += fi sh er ’s e xa ct te st
70 I EMMAOHLSSON-NEVO Colorectalcancer Table 12. Mental wellbeing (MACL)in next-of-kin
Baseline 1 month 6 month 12 month
PEP
n=39 Control n=25 p PEP n=37 Control n=23 p n=36PEP Control n=18 p n=33PEP Control n=22 p
OVERALL MOOD BMm (SD) 3.04(0.60) Mean (SD) 3.07(0.65 3.00(0.50) 0.66 2.95(0.71) 3.03(0.49) 0.64 2.92(0.71) 3.13(0.48) 0.28 3.08(0.63) 3.11(0.53) 0.83 >BM-m [%] 25/39[64] 17/25[68] 0.79+ 21/37[57] 15/22[68] 0.42+ 19/35[54] 13/18[72] 0.25+ 23/33[70] 14/22[64] 0.77+ Activation BM-a (SD) 3.10(0.59) mean (SD) 3.12(0.67 3.09(0.45) 0.90 2.97(0.69) 3.11(0.51) 0.58 2.95(0.72) 3.17(0.43) 0.22 3.12(0.58) 3.13(0.52) 0.95 > than BM-a [%] 24/39[61] 15/25[60] 0.90+ 22/37[60] 15/22[68] 0.60+ 22/36[61] 13718[72] 0.42+ 20/33[61] 14/22[62] 0.81+ Calmness Mean BM-c 2.90(0.69 Mean (SD) 2.95(0.75) 2.82(0.59) 0.45 2.87(0.86) 2.91(0.58) 0.81 2.83(0.81) 3.04(0.81) 0.33 2.95(0.73) 3.01(0.67) 0.77 > than BM-c [%] 25/40[62] 13/25[52] 0.40+ 21/37[57] 11/23[48] 0.78+ 22/38[58] 12/18[67] 0.53+ 21/33[64] 14/22[63] 1.0+ Pleasantness Mean BM-p (SD) 3.06(0.66) Mean (SD) 3.09(0.69) 3.02(0.58) 0.64 3.0(0.73) 3.01(0.52) 0.93 2.95(0.72) 3.15(0.53) 0.36 3.12(0.70) 3.17(0.56) 0.77 > than BM-p [%] 23/39[59] 15/25[60] 1.0+ 23/37[62] 13/22[56] 0.59+ 20/36[55] 13/18[72] 0.37+ 22/33[67] 15/22[68] 1.0+ Overall Mood (Activation, Calmness, Pleasantness): range 1-4; high score represent better mood,
BM= Baseline mean (both PEP. group and control group) m= overall mood, a= activation, c= calmness p= pleasantness [%] = percentage within the intervention group resp. control group
£= Mann-Whitney test +=fisher’s exact test
E MM A O HL SS O N -N E VO C ol or ec ta lc anc er I 71 T abl e 1 3. A nxi at y a nd de pr es si on in ne xt -of -ki n B ase lin e 1 m ont h 6 m ont h 12 m ont h P EP n=39 C on tr ol n=25 p P EP n=37 C on tr ol n=23 p P EP n=36 C on tr ol n=18 p P EP n=33 C on tr ol n=22 p AN X IATY BM -a (S D ) 6. 35( 4. 65) Me an (S D ) 5. 75( 4. 81) 7. 28( 4. 32) 0. 20 6. 10( 5. 66) 6. 42( 3. 97) 0. 81 6. 14( 4. 8) 5. 00( 5. 0) 0. 45 5. 51( 4. 62) 5. 45( 4. 96) 0. 96) >B M -a [% ] 15/ 37[ 40] 12/ 25[ 48] 0. 60+ 13/ 37[ 35] 9/ 21[ 43] 0. 79+ 14/ 37[ 38] 6/ 19[ 32] 0. 77+ 12/ 33[ 36] 7/ 22 0. 78+ D EP R ES SI O N BM -d (S D ) 3. 99( 3. 79) m ea n (S D )£ 4. 05( 4. 17) 3. 92( 3. 22) 0. 60 4. 20( 4. 23) 3. 13( 3. 43) 0. 56 4. 08( 4. 64) 2. 66( 3. 51) 0. 25 3. 51( 3. 65) 3. 22( 3. 91) 0. 44 > t ha n B M -d [% ] 13/ 38[ 34] 9/ 25[ 36] 1. 0+ 16/ 37[ 43] 6/ 23[ 26] 0. 27 11/ 36[ 30] 4/ 19[ 21] 0. 54 11/ 33[ 33] 7/ 22[ 32] 1. 00 A nxi et y a nd de pr es si on; S ca le r an ge 0 -2 1; h ig h s co re r ep res en t sy mp to ms . B M = B as el in e m ea n ( bot h int er ve nt ion g roup a nd c ont rol g roup) a=a nx ie ty d=de pr es si on . [ % ] = p er cen tag e w it hi n the int er ve nt ion g roup re sp . c ont rol g roup £= M ann -W hi tn ey te st += fi sh er ’s e xa ct te st
EMMAOHLSSON-NEVO Colorectalcancer I 71 Table 13. Anxiaty and depression in next-of-kin
Baseline 1 month 6 month 12 month
PEP n=39 Control n=25 p PEP n=37 Control n=23 p PEP n=36 Control n=18 p PEP n=33 Control n=22 p ANXIATY BM-a (SD) 6.35(4.65) Mean (SD) 5.75(4.81) 7.28(4.32) 0.20 6.10(5.66) 6.42(3.97) 0.81 6.14(4.8) 5.00(5.0) 0.45 5.51(4.62) 5.45(4.96) 0.96) >BM-a [%] 15/37[40] 12/25[48] 0.60+ 13/37[35] 9/21[43] 0.79+ 14/37[38] 6/19[32] 0.77+ 12/33[36] 7/22 0.78+ DEPRESSION BM-d (SD) 3.99(3.79) mean (SD)£ 4.05(4.17) 3.92(3.22) 0.60 4.20(4.23) 3.13(3.43) 0.56 4.08(4.64) 2.66(3.51) 0.25 3.51(3.65) 3.22(3.91) 0.44 > than BM-d [%] 13/38[34] 9/25[36] 1.0+ 16/37[43] 6/23[26] 0.27 11/36[30] 4/19[21] 0.54 11/33[33] 7/22[32] 1.00 Anxiety and depression; Scale range 0-21; high score represent symptoms.
BM= Baseline mean (both intervention group and control group) a=anxiety
d=depression.
[ %] = percentage within the intervention group resp. control group £= Mann-Whitney test
+=fisher’s exact test
72 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er Ta bl e 14. S F-36 m en tal su bs cal e s co res a o f ne xt -of -k in in t he int er ve nt io n ( PE P; n= 38) a nd c ont ro l ( C O N ; n= 24 ) gr oup s V ita lit y So cia l Fu nc tio ni ng R ol e-E m ot ion al M en tal H eal th PEP C ON p b ES c PEP C ON p ES PEP C ON p ES PEP C ON p ES B as elin e 62. 9 (25. 0) 56. 8 (20. 4) 0. 31 0. 27 79. 2 (24. 5) 79. 7 (27. 8) 0. 68 0. 02 74. 8 (38. 9) 72. 2 (41. 3) 0. 86 0. 06 74. 0 (21. 0) 68. 3 (22. 3) 0. 30 0. 26 1 m 58. 1 (25. 1) 66. 5 (17. 1) 0. 16 0. 40 81. 9 (20. 5) 88. 1 (17. 8) 0. 26 0. 32 76. 1 (39. 7) 80. 9 (34. 3) 0. 74 0. 13 74. 9 (23. 3) 75. 8 (18. 8) 0. 93 0. 04 6 m 61. 6 (27. 2) 69. 2 (18. 8) 0. 28 0. 34 79. 6 (25. 4) 89. 7 (24. 7) 0. 04 0. 55 80. 7 (35. 2) 84. 3 (31. 4) 0. 77 0. 11 74. 9 (23. 7) 78. 6 (19. 8) 0. 80 0. 17 12 m 66. 4 (23. 1) 66. 8 (20. 1) 0. 98 0. 02 83. 2 (20. 1) 86. 9 (21. 5) 0. 50 0. 18 87. 3 (30. 1) 84. 1 (32. 7) 0. 60 0. 10 78. 9 ( 19 .1) 77. 3 (23. 9) 0. 90 0. 07 V al ue s ( exc ept p -v al ue s and ES ) re pre se nt t he m ea n ( SD ) sc ore . aSF -36 s ub sc al es h ad a r an ge o f 0 -1 00. H ig he r sc or es indi ca te d be tt er he al th -r el ate d q ua lity o f l ife ( H R Q L ) b Tes t o f bet w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= e ff ec t s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = l ar ge e ff ec t) m = m ont h( s)
72 I EMMAOHLSSON-NEVO Colorectalcancer
Table 14. SF-36 mental subscale scoresa of next-of-kin in the intervention (PEP; n=38) and control (CON; n=24) groups
Vitality Social Functioning Role-Emotional Mental Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
Baseline 62.9 (25.0) (20.4) 56.8 0.31 0.27 (24.5) 79.2 (27.8) 79.7 0.68 0.02 (38.9) 74.8 (41.3) 72.2 0.86 0.06 (21.0) 74.0 (22.3) 68.3 0.30 0.26 1 m 58.1 (25.1) (17.1) 66.5 0.16 0.40 (20.5) 81.9 (17.8) 88.1 0.26 0.32 (39.7) 76.1 (34.3) 80.9 0.74 0.13 (23.3) 74.9 (18.8) 75.8 0.93 0.04 6 m 61.6 (27.2) (18.8) 69.2 0.28 0.34 (25.4) 79.6 (24.7) 89.7 0.04 0.55 (35.2) 80.7 (31.4) 84.3 0.77 0.11 (23.7) 74.9 (19.8) 78.6 0.80 0.17 12 m 66.4 (23.1) (20.1) 66.8 0.98 0.02 (20.1) 83.2 (21.5) 86.9 0.50 0.18 (30.1) 87.3 (32.7) 84.1 0.60 0.10 ( 19.1) 78.9 (23.9) 77.3 0.90 0.07
Values (except p-values and ES) represent the mean (SD) score.
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life (HRQL) b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) m= month(s) E MM A O HL SS O N -N E VO C ol or ec ta lc anc er I 73 Ta bl e 15. S F-36 m en tal su bs cal e s co res a o f ne xt -of -k in in t he int er ve nt io n ( PE P; n= 38) a nd c ont ro l ( C O N ; n= 24 ) gr oup s V ita lit y So cia l Fu nc tio ni ng R ol e-E m ot ion al M en tal H eal th PEP C ON p b ES c PEP C ON p ES PEP C ON p ES PEP C ON p ES C ha ng e 0-1 m -3. 18 (17. 5) 12. 6 (18. 4) 0. 00 0. 53 4. 17 (17. 3) 7. 14 (22. 9) 0. 59 0. 14 2. 29 (16. 9) 8. 0 (17. 6) 0. 23 0. 33 2. 29 (16. 9) 8. 0 (17. 6) 0. 23 0. 33 p d 0. 48 <0. 00 0. 25 0. 15 0. 38 0. 29 0. 07 0. 01 SRM e 0. 18 0. 68 0. 24 0. 31 0. 14 0. 45 0. 14 0. 45 0-6 m 0. 81 (21. 8) 10. 0 (11. 5) 0. 11 0. 55 -1. 13 (20. 8) 6. 6 (25. 0) 0. 25 0. 24 7. 58 (38. 4) 5. 88 (47. ) 0. 89 0. 04 0. 36 (16. 5) 10. 8 (18. 8) 0. 04 0. 59 p 0. 69 <0. 00 0. 79 0. 39 0. 21 0. 48 0. 31 0. 01 SRM 0. 04 0. 87 0. 05 0. 26 0. 20 0. 02 0. 02 0. 57 0-12 m 4. 37 (17. 4) 8. 73 (11. 1) 0. 33 0. 30 0. 0 (19. 5) 5. 9 (21. 1) 0. 33 0. 29 13. 2 (37. 1) 11. 1 (34. ) 0. 85 0. 06 2. 67 (19. 0) 9. 9 (21. 3) 0. 23 0. 36 p 0. 20 <0. 01 0. 91 0. 20 0. 08 0. 14 0. 46 0. 02 SRM 0. 25 0. 79 0.0 0. 27 0. 36 0. 33 0. 02 0. 42 V al ue s ( exc ept p -v al ue s, ES a nd SR M ) r epr es ent t he m ea n ( SD ) s cor e aSF -36 s ubs ca le s ha d a r ang e of 0 -100. H ig he r s cor es ind ic at ed b et te r he al th -r el at ed q ua lit y o f lif e b Tes t o f bet w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= ef fe ct s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m od er at e, a nd >0 .8 = l ar ge e ff ec t) d Te st o f w ith in -g roup cha ng e f rom ba se lin e to f ol low -up (W ilc oxon S ig ne d-ra nk te st) e SR M = S ta nda rd iz ed R es pons e M ea n m= m ont h( s)
EMMAOHLSSON-NEVO Colorectalcancer I 73
Table 15. SF-36 mental subscale scoresa of next-of-kin in the intervention (PEP; n=38) and control (CON; n=24) groups
Vitality Social Functioning Role-Emotional Mental Health
PEP CON pb ESc PEP CON p ES PEP CON p ES PEP CON p ES
Change 0-1 m -3.18 (17.5) (18.4) 12.6 0.00 0.53 (17.3) 4.17 (22.9) 7.14 0.59 0.14 (16.9) 2.29 (17.6) 8.0 0.23 0.33 (16.9) 2.29 (17.6) 8.0 0.23 0.33 pd 0.48 <0.00 0.25 0.15 0.38 0.29 0.07 0.01 SRMe 0.18 0.68 0.24 0.31 0.14 0.45 0.14 0.45 0-6 m 0.81 (21.8) (11.5) 10.0 0.11 0.55 (20.8) -1.13 (25.0) 6.6 0.25 0.24 (38.4) 7.58 (47.) 5.88 0.89 0.04 (16.5) 0.36 (18.8) 10.8 0.04 0.59 p 0.69 <0.00 0.79 0.39 0.21 0.48 0.31 0.01 SRM 0.04 0.87 0.05 0.26 0.20 0.02 0.02 0.57 0-12 m 4.37 (17.4) (11.1) 8.73 0.33 0.30 (19.5) 0.0 (21.1) 5.9 0.33 0.29 (37.1) 13.2 (34.) 11.1 0.85 0.06 (19.0) 2.67 (21.3) 9.9 0.23 0.36 p 0.20 <0.01 0.91 0.20 0.08 0.14 0.46 0.02 SRM 0.25 0.79 0.0 0.27 0.36 0.33 0.02 0.42
Values (except p-values, ES and SRM) represent the mean (SD) score
aSF-36 subscales had a range of 0-100. Higher scores indicated better health-related quality of life b Test of between-group differences (Mann-Whitney U-test)
c ES= effect size (Cohen’s effect size index (0. 2 to <0. 5 = small, 0.5 to <0.8 = moderate, and >0.8 = large effect) d Test of within-group change from baseline to follow-up (Wilcoxon Signed-rank test)
e SRM= Standardized Response Mean m=month(s) 74 I E MMA O H LS SO N -NE V O C ol or ec ta lc anc er T abl e 1 6. SF -36 phy si ca l s ubs ca le s cor es a of ne xt -of -ki n i n t he int er ve nt ion ( PE P; n= 38) a nd c ont rol ( C ON ; n= 24) Phy si ca l Func ti on Ro le -Phy si ca l B odi ly Pa in G en er al H ea lt h PEP CO N p b ES c PEP CO N p ES PEP CO N p ES PEP CO N p ES B as elin e 81. 2 (20. 3) 86. 2 (15. 6) 0.4 7 0.2 8 71. 2 (41. 7) 83. 3 (32. 7) 0.2 8 0.3 2 73. 1 (26. 7) 67. 1 (25. 5) 0.2 8 0.2 3 70. 4 (21. 7) 69. 3 (23. 1) 0.9 4 0.0 5 1 m ont h 82. 2 (22. 6) 85. 9 (15. 8) 0.9 1 0.1 7 71. 8 (41. 0) 79. 7 (29. 1) 0.8 7 0.2 3 66. 2 (27. 8) 73. 4 (27. 3) 0.3 6 0.2 6 69. 1 (21. 4) 66. 8 (20. 4) 0.6 8 0.1 1 6 m ont hs 78. 7 (23. 6) 82. 6 (15. 2) 0.9 4 0.2 0 69. 3 (40. 6) 83. 8 (34. 1) 0.2 3 0.3 9 72. 2 (26. 6) 73. 9 (21. 1) 1.0 0.0 7 66. 6 (22. 5) 73. 6 (20. 3) 0.2 9 0.3 3 12 m ont hs 83. 3 (17. 6) 81. 7 (21. 1) 1.0 0.0 8 83. 6 (35. 5) 76. 2 (39. 1) 0.3 8 0.2 0 77. 4 (20. 6) 73. 5 (21. 1. ) 0.4 8 0.0 5 68. 7 (15. 4) 72. 4 (20. 1) 0.4 6 0.2 1 V al ues ( ex cep t p-va lue s and SR M ) r ep res en t th e me an ( SD ) sco re. aSF -36 s ubs ca le s h ad a r an ge of 0 -1 00. H ig he r sc or es indi ca te d be tt er he al th -r el ate d q ua lity o f l ife b Tes t o f bet w een -g roup di ff er enc es ( M ann -W hi tne y U -te st) c E S= e ff ec t s iz e ( C ohe n’ s ef fe ct s iz e i nde x ( 0. 2 t o <0 . 5 = s m al l, 0. 5 t o <0. 8 = m ode ra te , a nd >0 .8 = la rg e ef fe ct )