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

N/ANot Yet RecruitingNCT07415564

University of Arizona200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

Symptom Management and Survivorship Handbook + CoachingBEHAVIORAL

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 HandbookBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 10 weeks

Secondary Outcomes

Health Related Quality of Life (HRQoL)

Determine whether SMSH combined with health coaching improves HRQoL (social, physical, psychological) at week 11 compared to SMSH alone. HRQoL will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Profile-43, which is suitable for both survivors and caregivers and is available in English and Spanish. PROMIS domains include depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with participation in social roles. Each item uses a 5-point Likert scale (1-5) plus a single pain intensity rating (0-10 for direct pain assessment). The scores for each domain are not summed into a single score and are meant to be used together to reflect HRQoL domains. A T-score of 50 represents the U.S. general population average, with a standard deviation of 10. Higher scores indicate worse outcomes for symptoms/interference, but better outcomes for physical function.

Time frame: 11 weeks