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

NCT07415564 | Not Yet Recruiting

• 1 other identifier: STUDY00007379
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

cancer; Metastatic cancer; Symptom management; Cancer survivorship; Cancer caregivers

Outcome Measures

Primary Outcomes (1)

• Symptom severity

  Assess whether SMSH combined with health coaching reduces the burden of 24 symptoms over 10 weeks compared to SMSH alone. Symptom burden will be measured using summary severity and interference scores from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE). Severity is rated on a scale of 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Interference is rated on a scale of 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. Frequency is rated as 0=never, 1=rarely, 2=occasionally, 3=frequently, 4=almost constantly. As outlined in the PRO-CTCAE, frequency, severity, and interference questions will be asked for each item available. If frequency is "never," severity and interference will not be asked. Summary scores for severity and interference will be derived from the toxicity index (TI) developed by Rogatko et al. for CTCAE grades and applied to the PRO-CTCAE scores over weeks 1-8. Higher scores indicate worse outcomes.

  10 weeks

Secondary Outcomes (1)

• Health Related Quality of Life (HRQoL)

  11 weeks

Study Arms (2)

Symptom Management and Survivorship Handbook (SMSH)

ACTIVE COMPARATOR

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.

Behavioral: Symptom Management and Survivorship Handbook

Symptom Management and Survivorship Handbook + Coaching

EXPERIMENTAL

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.

Behavioral: Symptom Management and Survivorship Handbook + Coaching

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.

Also known as: SMSH+

Symptom Management and Survivorship Handbook + Coaching

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.

Also known as: SMSH alone

Symptom Management and Survivorship Handbook (SMSH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Neoplasm Metastasis; Signs and Symptoms; Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Terry A Badger, RN, PhD

  University of Arizona College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Hadeed, MPA, MSPH

CONTACT

520-626-0583; mcbarry@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share