NCT07415564 Symptom Management and Survivorship Plus Coaching for Advanced Cancer Survivors and Their Caregivers
| NCT ID | NCT07415564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arizona |
| Condition | Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-05-06 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Terry A Badger, RN, PhD
PRINCIPAL INVESTIGATOR
University of Arizona College of Nursing
Frequently Asked Questions
Who can join the NCT07415564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07415564 currently recruiting?
Yes, NCT07415564 is actively recruiting participants. Contact the research team at mcbarry@arizona.edu for enrollment information.
Where is the NCT07415564 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT07415564 clinical trial?
NCT07415564 is sponsored by University of Arizona. The principal investigator is Terry A Badger, RN, PhD at University of Arizona College of Nursing. The trial plans to enroll 200 participants.
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