Randomized clinical trial to evaluate a cancer pain self-management intervention for outpatients

OBJECTIVE: Unrelieved pain is common in patients with advanced cancer. Although psychoeducational interventions were found to decrease pain, effects were moderate. The purpose of this study was to evaluate the efficacy of a pain self-management intervention compared with usual care and to explore participants’ experiences with pain management and study participation. METHODS: A multicenter randomized controlled trial design with post-trial interviews was used. Outpatients with cancer pain and their family caregivers were recruited from three Swiss university hospitals. The intervention group (IG) received the six-week intervention consisting of education, skills building, and nurse coaching. The control group (CG) received usual care. Outcome variables were analyzed using multilevel models. Interpretive description guided the qualitative study part. RESULTS: Twenty-one patients with advanced cancer and seven family caregivers completed the study. The group x time effect showed a statistically significant decrease in average pain (P ​= ​0.04), but no significant group x time effect for worst pain (P ​= ​0.06). Pain scores, pain-related knowledge, Pain Management Index, self-efficacy, and performance status improved in the IG (P ​< ​0.05). Almost all of the interviewed participants perceived the pain management diary, tailored intervention sessions, and weekly support as useful. None experienced study participation as burdensome. CONCLUSIONS: This study was the first to test the efficacy of a psychoeducational cancer pain self-management intervention in a German-speaking context, with most patients receiving palliative care. Clinicians can recommend the use of pain management diaries. Tailoring interventions to an individual's situation and dynamic pain trajectory may improve patients' pain self-management. REGISTRATION NUMBER: This study has been registered via ClinicalTrials.gov: NCT02713919.https://clinicaltrials.gov/ct2/show/NCT02713919?term=NCT02713919&amp;draw=2&amp;rank=1.