Abstract
Context
Many cancer survivors and their informal caregivers experience multiple symptoms during the survivor’s treatment.
Objective
Test relative effectiveness and optimal sequencing of two evidence-based interventions for symptom management.
Methods
In this sequential multiple assignment randomized trial (SMART), survivors of solid tumors with elevated depression or anxiety and their caregivers as dyads were initially randomized after baseline assessment in a 3:1 ratio to the
Symptom Management and Survivorship Handbook
(SMSH,
N
= 277 dyads) intervention or SMSH plus 8 weeks of telephone interpersonal counseling (TIPC,
N
= 97 dyads). After 4 weeks, survivors who were not responding (no improvement or worsening score on depression and/or anxiety item) to SMSH only and their caregivers were re-randomized to continue with SMSH alone (
N
= 44 dyads) to give it more time or to SMSH + TIPC (
N
= 44 dyads). Mixed effects and generalized linear models compared severity of depression, anxiety, and a summed index of 16 other symptoms over weeks 1–13 and week 17 between randomized groups and among three dynamic treatment regimes (DTRs). Dyads received SMSH only for 12 weeks (DTR1); SMSH for 12 weeks with 8 weeks of TIPC added from week 1 (DTR2); and SMSH for 4 weeks followed by the combined SMSH + TIPC for 8 weeks if no response at 4 weeks (DTR3).
Results
Survivors randomized initially to SMSH alone had significantly lower anxiety over weeks 1–13 compared to those randomized to the combined SMSH + TIPC. In comparing DTRs, survivor’s anxiety was significantly lower at week 13 for DTR1 compared to DTR2 with no other main effects for survivors or caregivers. Exploratory moderation analyses indicated a potential benefit of adding TIPC for caregivers of non-responders with elevated baseline symptoms.
Conclusion
SMSH + TIPC did not result in better symptom outcomes at week 17 than SMSH alone. Lower intensity SMSH may improve depression and anxiety symptoms for most survivors and their caregivers.
Trial registration
Clinicaltrails.gov ID number, NCT03743415; approved and posted on 11/16/2018.