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

Conditions

• Cancer Metastatic
• Quality of Life
• Symptoms and Signs

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Symptom Management and Survivorship Handbook + Coaching — BEHAVIORAL
  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 — BEHAVIORAL
  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.

Study Details

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.

Key Dates

First listed

Feb 17, 2026

Start date

May 6, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

Symptom severity [ Time Frame: 10 weeks ]

Central Contacts

• Molly Hadeed, MPA, MSPH
  520-626-0583
  [email protected]

Locations (1)

Find similar trials in Tucson, AZ

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