Distress after a psychosocial cancer rehabilitation course. Main effects and effect modification in a randomised trial at 12 months of follow-up

Figures & data

Figure 1. Randomisation and follow-up of cancer patients participating in the study of cancer rehabilitation in Denmark, 2004–2008.

Table I. Baseline characteristics of patients with breast, prostate or colorectal cancer (n = 507) in a randomised controlled trial of a cancer rehabilitation intervention, by receivers and non-receivers of the intervention although allocated, and receivers of the allocated control condition.

	Intervention arm n = 259		Control arm n = 248^1
	Received allocated intervention n = 208	Did not receive allocated intervention n = 51	Received allocated control condition n = 244
Diagnosis
Breast cancer	122 (59%)	20 (39%)	116 (48%)
Prostate cancer	32 (15%)	9 (18%)	58 (24%)
Colorectal cancer	54 (26%)	22 (43%)	70 (29%)
Gender
Male	62 (30%)	17 (33%)	100 (41%)
Female	146 (70%)	34 (67%)	144 (59%)
Mean age (years) (5–95%)	60 (41–75)	61 (39–82)	62 (41–78)
Education
Basic	18 (9%)	8 (16%)	27(11%)
Youth	82 (39%)	17 (33%)	91 (37%)
Higher	99 (48%)	24 (47%)	118 (48%)
Unknown	9 (4%)	2 (4%)	8 (3%)
Employment status
Working	97 (47%)	25 (49%)	115 (47%)
Pensioner/other	92 (44%)	22 (43%)	111 (45%)
Sick leave/unemployed	9 (4%)	1 (2%)	7 (3%)
Unknown	10 (5%)	3 (6%)	11 (5%)
Marital status
Married or cohabiting	147 (71%)	36 (71%)	179 (73%)
Living alone	61 (29%)	15 (29%)	65 (27%)
Time since diagnosis (months) (5–95%)	13.8 (2.5–26.2)	16.1 (4.0–28.1)	14.7 (3.4–26.6)
Cancer stage
Low risk	64 (31%)	19 (37%)	91 (37%)
High risk	134 (64%)	23 (45%)	147 (60%)
Unknown	10 (5%)	9 (18%)	6 (2%)
Surgery
Yes	179 (86%)	36 (71%)	196 (80%)
No	11 (5%)	5 (10%)	21 (9%)
Unknown	18 (9%)	10 (20%)	27 (11%)
Chemotherapy
Yes	46 (22%)	8 (35%)	61 (25%)
No	99 (48%)	18 (35%)	104 (43%)
Unknown	63 (30%)	25 (49%)	79 (32%)
Radiotherapy
Yes	48 (23%)	6 (12%)	38 (16%)
No	127 (61%)	28 (55%)	169 (69%)
Unknown	33 (16%)	17 (33%)	37 (15%)
Hormone treatment^1
Yes	61 (40%)	7 (24%)	61 (34%)
No	30 (19%)	9 (31%)	50 (28%)
Unknown	63 (41%)	13 (45%)	63 (36%)
Mean total mood disturbance score (POMS-Sf) (SD)	9.3 (22.9)	5.3 (19.0)	6.3 (18.0)

¹Numbers receiving hormone treatment are only patients with breast or prostate cancer, as colorectal cancer patients do not receive hormone treatment.

Table II. Adjusted analysis of changes between baseline and 12 months of follow-up. Included as predictors are: intervention, distress score at baseline, gender, time since diagnosis, age at baseline, cancer diagnosis and education as well as all interactions with intervention status (i.e. intervention or control group). The estimate is reported as point changes in POMS TMD.

	Estimate	95% CI	p-Value
Direct effect
Intervention (vs. control)	−16.53	−58.18–25.12	0.44
Baseline distress (points on TMD)	0.50	0.34–0.66	0.00
Gender (women vs. men)	−4.31	−15.09–6.47	0.43
Time since diagnosis (days)	−0.00	−0.02–0.02	0.59
Age at baseline (years)	0.08	−0.21–0.37	0.58
Prostate cancer (vs. breast cancer)	−6.06	−19.05–6.93	0.36
Colorectal cancer (vs. breast cancer)	−5.32	−15.36–4.72	0.30
Education (per increasing levela)	−2.28	−6.49–1.93	0.29
Interactions
Intervention*baseline distress	0.09	−0.11–0.29	0.41
Intervention*gender	2.35	7.63–17.30	0.76
Intervention*time since diagnosis	0.00	−0.02–0.02	0.69
Intervention*age at baseline	0.21	−0.24–0.66	0.36
Intervention*prostate cancer diagnosis	−3.55	−21.95–14.85	0.71
Intervention*colorectal cancer diagnosis	−3.49	−16.82–9.84	0.61
Intervention*education	1.16	−3.92–6.24	0.65

^aLevels of education: Basic education, youth education, higher education.

Table III. Adjusted analysis of changes between baseline and 12 months of follow-up, where measurements at 1- and 6-months follow-up are included. Included as predictors are: intervention, distress score at baseline, gender, time since diagnosis, age at baseline, cancer diagnosis and education as well as all interactions with intervention status (i.e. intervention or control group).

	p-Value
Direct effect
Intervention	0.82
6-months follow-up	0.28
12-months follow-up	0.35
Baseline distress	0.00
Gender	0.80
Time since diagnosis	0.58
Age at baseline	0.82
Diagnostic group^a	0.73
Education^b	0.26
Interactions
Intervention*baseline distress	0.20
Intervention*gender	0.78
Intervention*time since diagnosis	0.73
Intervention*age at baseline	0.33
Intervention*diagnostic group	0.10
Intervention*education	0.38

^aDiagnostic group: Breast cancer, Prostate cancer, Colorectal cancer; ^bLevels of education: Basic education, youth education, higher education.

Table IV. Adjusted analysis of changes between baseline and 12 months of follow-up including indicators of few psychosocial resources as possible effect modificators. As measurements at 1- and 6-months follow-up are included, the correlation between repeated observations (within patient) is accounted for. Included as predictors are: intervention, follow-up time, gender, time since diagnosis, age at baseline, cancer diagnosis and education as well as all interactions with intervention status (i.e. intervention or control group).

	p-Value
Direct effect
Intervention	0.00
Time	0.07
Gender	0.04
Time since diagnosis	0.11
Age at baseline	0.44
Diagnostic group^a	0.05
Education^b	0.16
Low vs. high baseline distress^c	0.00
General self-efficacy at baseline	0.00
Emotional support from the partner	0.00
Interactions
Intervention*gender	0.92
Intervention*time since diagnosis	0.75
Intervention*age at baseline	0.12
Intervention*diagnostic group	0.10
Intervention*education	0.40
Intervention*baseline distress (low vs. high)	0.01
Intervention*general self-efficacy	0.87
Intervention*Emotional support from the partner	0.68

^aDiagnostic group: Breast cancer, Prostate cancer, Colorectal cancer; ^bLevels of education: Basic education, youth education, higher education; ^cLow baseline distress defined as baseline total mood disturbance (TMD) ≤ 2, which was the median value.