Symptom Management and Survivorship Plus Coaching for Advanced Cancer Survivors and Their Caregivers
Recruiting · NCT07415564 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Arizona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina/o, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues. The specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads): Aim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11. Aim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone. Aim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone. The proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.
Who can take part
Inclusion criteria
- for cancer survivors:
- Age 18 or older
- Diagnosed with metastatic or stage IV breast, gastrointestinal (GI), and melanoma cancer
- Able to perform basic activities of daily living
- Cognitively oriented to time, place, and person (recruiter determined)
- Able to speak and understand English or Spanish
- Access to a telephone
- Has a caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can.
- Inclusion criteria for the caregivers:
- Age 18 or older
- Able to speak and understand English or Spanish
- Telephone access
- Not currently treated for cancer
Exclusion criteria
- Nursing home resident
- Bedridden
- Hospice care
- Currently receiving a symptom management intervention
Where it is running
1 location listed across 1 US state.
- University of Arizona Cancer Center - Tucson, Arizona, United States