Lifestyle intervention for Hispanic cancer survivors and their caregivers
Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers
This study is testing a 12-week program to help Hispanic cancer survivors and their caregivers eat healthier and be more active to see if it improves their health and well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 217 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT05364372 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate a 12-week lifestyle intervention designed to improve the health of Hispanic cancer survivors and their caregivers. The intervention focuses on increasing fruit and vegetable intake and physical activity while reducing symptom severity among participants. The study will involve 107 dyads of Hispanic cancer survivors who have completed treatment within the past two years and their informal caregivers, with outcomes measured at baseline, 13 weeks, and 25 weeks. The trial also seeks to understand the role of social support and self-efficacy in mediating these health improvements.
Who should consider this trial
Good fit: Ideal candidates include female Hispanic cancer survivors aged 18 or older who have completed curative treatment within the last two years and experience significant cancer-related symptoms.
Not a fit: Patients currently undergoing cancer treatment or those without a willing caregiver may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and health outcomes for Hispanic cancer survivors and their caregivers.
How similar studies have performed: Previous studies have shown promising results with lifestyle interventions targeting cancer survivors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for female Hispanic cancer survivors: 1. 18 years of age or older; 2. have access to a telephone, 3. speak and understand English or Spanish; 4. have finished curative intent treatment for cancer within the previous 10 years and do not have any subsequent cancer treatments planned, except for non-curative intent maintenance therapy, such as hormonal therapy; 5. must have at least 1 of the 5 most common cancer-related symptoms (pain, sleep disturbance, anxiety, depression and/or fatigue) with a severity score of 4 or higher on a 0-10 rating scale (based on NCCN guidelines for symptom monitoring and management used successfully in past work); and 6. has a caregiver willing to participate in the study with them. Inclusion criteria for the caregivers (nominated by the survivor) are: 1. age 18 or older; 2. able to speak and understand English or Spanish; 3. access to a telephone; and 4. not currently treated for cancer preserving the distinction between survivor and caregiver. The caregiver can be of any race or ethnicity and any gender. Exclusion criteria for survivors: 1. Under the age of 18 years 2. Does not have access to a telephone 3. Completed treatment for cancer more than 1 year ago 4. Currently receiving counseling or treatment for special diet or weight loss 5. Does not have a caregiver willing to participate with them Exclusion criteria for caregivers: 1. Under the age of 18 years 2. Does not have access to a telephone 3. Currently receiving counseling or treatment for special diet or weight loss 4. Currently being treated for cancer
Where this trial is running
Tucson, Arizona
- University of Arizona — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Bea, PhD — University of Arizona
- Study coordinator: Samantha Werts, MPH
- Email: swerts@arizona.edu
- Phone: 520-626-8712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.