No effect on survival of home psychosocial intervention in a randomized study of Danish colorectal cancer patients.

OBJECTIVE: We investigated whether regular home visits to persons with newly diagnosed colorectal cancer influenced their overall survival and selected immune parameters. METHODS: A total of 249 Danish colorectal cancer patients undergoing abdominal surgery were randomly assigned to a control or an intervention group. The intervention group received 10 home visits from a project nurse or a medical doctor during the first 2 years after discharge. The home visits aimed at providing emotional support and information. A subgroup of 55 patients provided blood samples 3, 12 and 24 months after discharge for measurement of immune parameters. Survival was assessed 6.5-9.5 years after the first operation. RESULTS: A total of 148 patients died during follow-up. The intervention was not significantly associated with survival (p=0.68) after adjustment for Dukes' stage, radicality of the operation, age, sex, family social class and marital status. Likewise, no significant interactions were found between group and these covariates (all p > or = 0.08). In the substudy of the possible effect of the intervention on immune parameters, there were no differences between the two groups with respect to lymphocyte proliferation (all p > or = 0.078) or natural killer cell activity (all p > or = 0.33) and no consistent effect on the number of specific subsets of cells (phenotypes) during follow-up. CONCLUSION: The study failed to provide evidence that the psychosocial intervention provided as home visits significantly affected the prognosis or selected immune parameters of patients who had undergone surgery for colorectal cancer.

Survival after a psychoeducational intervention for patients with cutaneous malignant melanoma: a replication study.

PURPOSE: The results of a randomized, intervention study done in 1993 of psychoeducation for patients with early-stage malignant melanoma showed a beneficial effect on recurrence and survival 6 years after the intervention. In the present study, we replicated the study with 258 Danish patients with malignant melanoma. We also compared recurrence and survival among the participants in the randomized study with 137 patients who refused to participate. PATIENTS AND METHODS: We randomly assigned 262 patients with primary malignant melanoma to a control or an intervention group. Patients in the intervention group were offered six weekly 2-hour sessions of psychoeducation. Participants and nonparticipants were followed up for vital status and recurrence 4 to 6 years after surgical treatment. Prognostic factors (thickness of the tumor and lymph node status), sex, and age were adjusted for in a Cox regression model (proportional hazards regression) to derive an adjusted survival rate ratio and an adjusted relapse-free survival rate ratio, with 95% CIs. RESULTS: The hazard ratio was 1.30 (95% CI, 0.5 to 3.5) for survival and 0.73 (95% CI, 0.3 to 1.9) for recurrence. Being a nonparticipant increased the risk for death by more than two-fold (hazard ratio, 2.26; 95% CI, 1.0 to 5.2) over that of participants. CONCLUSION: Psychoeducation did not increase survival or the recurrence-free interval among patients with malignant melanoma; however, nonparticipants had a statistically significantly greater risk for death than participants.