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Handbook and Phone Coaching for Symptoms in Advanced Cancer Survivors and Caregivers

Tests a symptom handbook with phone coaching in advanced cancer survivors and caregivers.

Key facts

Who runs it
University of Arizona
Where
Tucson, United StatesSee the site
Trial code
Registry title
Symptom Management and Survivorship Plus Coaching for Advanced Cancer Survivors and Their Caregivers
Status
Recruiting
People taking part
200 people, planned
Started
6 May 2026
Expected to end
Sept 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Symptom Management and Survivorship Handbook + Coaching
  • Symptom Management and Survivorship Handbook
Record updated
20 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with metastatic or stage IV breast, gut (GI) or melanoma cancer, together with a caregiver. Both receive a symptom handbook, and some also get phone coaching.

Age
Survivors and caregivers: 18 years or older.
Sex
All sexes can join.
Disease stage
Survivors: metastatic or stage IV breast, gastrointestinal (GI) or melanoma cancer.
Earlier treatment
Survivors and caregivers must not be currently receiving a symptom management intervention. Caregivers must not be currently treated for cancer.

Main reasons for not taking part

  • Nursing home resident
  • Bedridden
  • Hospice care
  • Currently receiving a symptom management intervention
  • Caregiver currently treated for cancer

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Currently receiving a symptom management intervention
  • Nursing home resident
  • Bedridden
  • Hospice care

Where in United States

  • University of Arizona Cancer CenterTucson, United StatesContact: Michele Chu-Pilli, MSTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Symptom Management and Survivorship Handbook (SMSH)Existing treatment, for comparison

    Survivors and caregivers are mailed a printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help survivors and caregivers manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Survivors and caregivers are called by an interventionist via telephone once a week for 10 weeks to assess symptoms and make referrals to chapters in the handbook based on their reports.

    Treatment: Symptom Management and Survivorship Handbook

  • Symptom Management and Survivorship Handbook + CoachingTreatment being tested

    Survivors and caregivers are mailed the printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help them manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Trained health coaches will call the survivor and caregiver separately each week for 10 weeks to assess symptoms, make referrals to SMSH, and use behavioral theory techniques to facilitate goal setting and symptom self-management.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Handbook and Phone Coaching for Symptoms in Advanced Cancer Survivors and CaregiversGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 July 2026