Recruiting

SMSH & Health Coaching

Sponsor:

University of Arizona

Code:

NCT07415564

Conditions

Cancer Metastatic

Symptoms and Signs

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Symptom Management and Survivorship Handbook + Coaching

Symptom Management and Survivorship Handbook

Study Details

Brief summary:

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.

Conditions

Cancer Metastatic

Symptoms and Signs

Quality of Life

Study ID

NCT07415564

Start date

May 6, 2026

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Symptom Management and Survivorship Handbook (SMSH)

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.

experimental: Symptom Management and Survivorship Handbook + Coaching

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.

Interventions

Symptom Management and Survivorship Handbook + Coaching

Coaches call survivors and caregivers separately each week. In week one, they introduce themselves and the intervention, explain the 10-call structure, and help participants prioritize symptoms and set management goals. Coaches review SMSH recommendations, coach on symptom management strategies, and use techniques such as motivational interviewing and self-monitoring. Coaches remind participants that some strategies help multiple symptoms, and recommend talking to a provider if any symptom scores above 3. In sessions 2-10, coaches check in, administer a symptom questionnaire, review prior goals, and document progress, barriers, and new goals. Each session covers discovery, desired outcome, pathways, context, and design.

Symptom Management and Survivorship Handbook

Survivors and caregivers receive a printed Symptom Management and Survivorship Handbook (SMSH), proven to help manage symptoms. The SMSH covers 24 common cancer symptoms (like fatigue, depression, sleep issues, pain), plus lifestyle, behavior, and survivorship guidelines. For 10 weeks, an interventionist calls weekly to assess symptoms and refer to relevant handbook chapters.

Primary outcome measure

  • Symptom severity [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Molly Hadeed, MPA, MSPH

520-626-0583mcbarry@arizona.edu

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Michele Chu-Pilli, MS

520-626-1183chum@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • cancer
  • Metastatic cancer
  • Symptom management
  • Cancer survivorship
  • Cancer caregivers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-07-20.