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NCT07415564Recruiting

Symptom Management and Survivorship Plus Coaching for Advanced Cancer Survivors and Their Caregivers

Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers

Source: ClinicalTrials.gov · Last updated 20 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
29 Jan 2026
Start date
May 2026
Primary completion date
Sept 2027
Lead sponsor
University of Arizona
Diseases
Melanoma
NCT number
NCT07415564

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From May 2026 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently receiving a symptom management intervention

Other

  • Nursing home resident
  • Bedridden
  • Hospice care

Who the study is looking for

  • 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.
  • Age 18 or older
  • Able to speak and understand English or Spanish
  • Telephone access
  • Not currently treated for cancer

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Arizona Cancer Center
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.