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

This study is looking at ways to help people with advanced cancer (metastatic or stage IV breast, gastrointestinal, or melanoma cancer) and their caregivers manage symptoms and improve their quality of life. You would receive a "Symptom Management and Survivorship Handbook" (SMSH) which has information on managing 24 common cancer symptoms like fatigue, depression, and pain. Some participants will also receive weekly phone calls from a coach to help them set goals and manage their symptoms. The study aims to see how much these interventions can reduce the severity of your symptoms over 10 weeks. They plan to enroll 200 participants. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 200 participants. It compares receiving a handbook alone versus receiving the handbook plus coaching.
What's involved
You would participate in a 10-week program. If in the coaching group, you and your caregiver would receive separate weekly phone calls from a coach.
Compensation
Not stated in the trial record.
Follow-up
Symptom severity will be measured at 10 weeks.

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NCT07415564

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

Recruiting
NAAges 18+InterventionalSupportive care
University of Arizona
~200 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Symptom Management and Survivorship Handbook + CoachingSymptom Management and Survivorship Handbook

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Symptom severity
Measured over 10 weeks
Cancer Metastatic
Symptoms and Signs
Quality of Life
1 sites across 1 states
Arizona1
  • Terry A Badger, RN, PhD · PRINCIPAL_INVESTIGATOR · University of Arizona College of Nursing

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Nursing home resident
Bedridden
Hospice care
Currently receiving a symptom management intervention
  • Symptom severity10 weeks

    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.