A Sequential Multiple Assignment Randomized Trial of Symptom Management After Chemotherapy

Abstract

Context: Many cancer survivors experience a lingering symptom burden after chemotherapy.

Objectives: In this sequential multiple assignment randomized trial, we tested optimal sequencing of two evidence-based interventions for symptom management.

Methods: Survivors of solid tumors (N = 451) were interviewed at baseline and stratified as high or low need for symptom management based on comorbidity and depressive symptoms. High need survivors were randomized initially to the 12-week Symptom Management and Survivorship Handbook (SMSH, N = 282) or 12-week SMSH with eight weeks of Telephone Interpersonal Counseling (TIPC, N = 93) added during weeks one to eight. After four weeks of the SMSH alone, non-responders on depression were re-randomized to continue with SMSH alone (N = 30) or add TIPC (N = 31). Severity of depression and summed severity index of 17 other symptoms over weeks one to13 were compared between randomized groups and among three dynamic treatment regimes (DTRs): 1) SMSH for 12 weeks; 2) SMSH for 12 weeks with eight weeks of TIPC from week one; 3) SMSH for four weeks followed by SMSH+TIPC for eight weeks if no response to the SMSH alone on depression at week four.

Results: There were no main effects for randomized arms or DTRs, but there was a significant interaction of trial arm with baseline depression favoring SMSH alone during weeks one to four in the first randomization and SMSH+TIPC in the second randomization.

Conclusion: The SMSH may represent a simple effective option for symptom management, adding TIPC only when there is no response to SMSH alone for people with elevated depression and multiple co-morbidities.

Keywords: Chemotherapy; depression; interpersonal counseling; sequential multiple assignment randomized trial; symptom management.