A sequential multiple assignment randomized trial of symptom management for cancer survivors during treatment and their informal caregivers.

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.

A Sequential Multiple Assignment Randomized Trial of Symptom Management After Chemotherapy.

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.

Social Determinants of Health and Symptom Burden During Cancer Treatment.

BACKGROUND: Cancer survivors (defined as individuals from diagnosis to the end of life) in treatment experience multiple physical and psychological symptoms (e.g., fatigue, pain, depression, anxiety, disturbed sleep) that influence their well-being and treatment outcomes. Underrepresented cancer survivors may disproportionately experience greater symptom burden (number of symptoms, symptom severity, depression, anxiety). OBJECTIVES: The aim of this study was to examine the relationships of social determinants of health, including age, ethnicity, education, income and whether income meets the survivor's needs, neighborhood (rural vs. urban), access to healthcare (e.g., insurance), and social isolation, with symptom burden in cancer survivors. METHODS: This secondary analysis included baseline data from 400 cancer survivors of solid tumor cancers undergoing chemotherapy or targeted therapy who participated in a larger randomized trial of symptom management interventions. Symptom burden was measured by the Center for Epidemiological Studies-Depression scale for depression and Patient-Reported Outcomes Measurement Information System scores for anxiety and social isolation, summed severity index of 16 symptoms from the General Symptom Distress Scale, and the total number of symptoms. Self-reported comorbid conditions were measured using the Bayliss tool. General linear models were used to relate symptom measures (one at a time) to age, number of comorbid conditions, level of education, marital status, income meeting needs, and size of metropolitan neighborhood. Additional covariates included site of cancer, its treatment, and whether the cancer was metastatic. RESULTS: Non-Hispanic White survivors ( n = 191) were older and had more comorbid conditions, a higher proportion of metastatic cancers, and higher levels of education and income compared with Hispanic survivors ( n = 168) and non-Hispanic survivors of other races ( n = 41). Compared with the other two groups, Hispanic survivors had the lowest rate of health insurance availability, and non-Hispanic survivors of other races had the lowest social isolation. Age, number of comorbid conditions, and social isolation were significantly associated with number of symptoms, symptom severity, and depression. Age and social isolation were associated with anxiety. In addition, the symptom severity of non-Hispanic White survivors was lower than that of Hispanic survivors and non-Hispanic survivors of other races. DISCUSSION: These findings highlight the health disparities in symptom burden experienced among cancer survivors when considering their social determinants of health. Assessing these may help clinicians address health disparities in cancer care.

Use of scheduled and unscheduled health services by cancer survivors and their caregivers.

PURPOSE: The purpose was to determine predictors of scheduled and unscheduled health services use by cancer survivors undergoing treatment and their informal caregivers. METHODS: English- or Spanish-speaking adult cancer survivors undergoing chemotherapy or targeted therapy for a solid tumor cancer identified a caregiver (N = 380 dyads). Health services use over 2 months was self-reported by survivors and caregivers. Logistic regression models were used to relate the likelihood of service use (hospitalizations, emergency department [ED] or urgent care visits, primary care, specialty care) to social determinants of health (age, sex, ethnicity, level of education, availability of health insurance), and number of comorbid conditions. Co-habitation with the other member of the dyad and other member's health services use were considered as additional explanatory variables. RESULTS: Number of comorbid conditions was predictive of the likelihood of scheduled health services use, both primary care and specialty care among caregivers, and primary care among survivors. Greater probability of specialty care use was associated with a higher level of education among survivors. Younger age and availability of health insurance were associated with greater unscheduled health services use (hospitalizations among survivors and urgent care or ED visits among caregivers). Unscheduled health services use of one member of the dyad was predictive of use by the other. CONCLUSIONS: These findings inform efforts to optimize health care use by encouraging greater use of scheduled and less use of unscheduled health services. These educational efforts need to be directed especially at younger survivors and caregivers.