The following is a summary of “A Sequential Multiple Assignment Randomized Trial of Symptom Management After Chemotherapy,” published in the JUNE 2023 issue of Pain Management by Sikorskii, et al.
For a sequential multiple-assignment randomized trial, researchers aimed to determine the optimal sequencing of two evidence-based interventions for symptom management in cancer survivors who experience a lingering symptom burden after chemotherapy.
A total of 451 survivors of solid tumors were included in the study. Baseline interviews were conducted, and participants were stratified into high or low need for symptom management based on comorbidity and depressive symptoms. High-need survivors were initially randomized into two groups: one receiving the 12-week Symptom Management and Survivorship Handbook (SMSH) alone (N = 282) and the other receiving the SMSH with eight weeks of Telephone Interpersonal Counseling (TIPC) added during weeks one to eight (N = 93). Non-responders on depression after four weeks of the SMSH alone were re-randomized into two groups: one continuing with the SMSH alone (N = 30) and the other adding TIPC (N = 31). The severity of depression and the summed severity index of 17 other symptoms over a period of 13 weeks were compared among the randomized groups and three dynamic treatment regimes (DTRs): 1) SMSH for 12 weeks, 2) SMSH for 12 weeks with TIPC from week one, and 3) SMSH for four weeks followed by SMSH+TIPC for eight weeks if no response to SMSH alone on depression at week four.
There were no significant main effects for the randomized arms or DTRs. However, there was a significant interaction between the trial arm and baseline depression, favoring the SMSH alone during weeks one to four in the first randomization period and SMSH+TIPC in the second randomization period.
The findings suggested that the SMSH may serve as a simple and effective option for symptom management in cancer survivors with a lingering symptom burden. The addition of TIPC should be considered only when there is no response to the SMSH alone, particularly for individuals with elevated depression and multiple comorbidities.