Latinas Integrating Fitness and Therapy
Part of paid clinical trials in Fort Collins, Colorado.
- Sponsor
- Colorado State University
- Study ID
- NCT07223346
- Status
- Recruiting
Conditions
- Anxiety Depression
- Exercise
- Physical Activity
- Stepped Care Cognitive Behavioral Therapy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Stepped Care Mental Health Counseling — BEHAVIORALCounseling Sessions: Everyone will have one orientation session with a counselor to learn about the study. After that, based on their levels of anxiety and depression, they may get between 1 and 7 counseling sessions. Milder levels of depression and anxiety will receive fewer sessions. The counseling sessions can include a self-help guide, coping strategies, self-help tips, and a type of therapy called cognitive behavioral therapy (CBT), which is specially adapted for Latina cancer survivors. The counseling sessions will take place online via zoom.
- Exercise Program — BEHAVIORALThe exercise program consists of easy to moderate aerobic and resistance training and discussions about staying active. These sessions will take place in your home, on zoom, led by a qualified exercise professional, and may be held in a group with other Latina cancer survivors. They will receive exercise equipment to use during the study and keep after the study ends. Exercise sessions are once per week for about an hour, and the discussion sessions take place before or after three of these sessions, and last about 30-45 minutes. If they miss a session or want to review, they will have access to recorded videos.
Study Details
Investigators are studying how combining a stepped-care mental health counseling program with an evidence-based exercise program can help Latina cancer survivors feel better mentally and physically. The goal is to improve stress, emotions, and physical activity during and after cancer treatment. In addition, investigators will examine the feasibility and acceptability of the intervention among Latina cancer survivors.
Key Dates
- Start date
- Oct 1, 2025
- Status verified
- Oct 2025
- Primary completion
- Dec 31, 2026
- Completion
- May 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Combining exercise program and stepped-care counselingInvestigators are offering Latinas who have cancer a combination of an exercise program and mental health that will take place online. All participants will receive an 8 week evidence-based exercise program. In addition, Latinas with cancer will take a survey on depression and anxiety to determine which level of mental counseling they will receive. They will take surveys at 2 weeks, 6 weeks, and 10 weeks to see if their levels of depression and anxiety have changed. If their symptoms increase they will receive more counseling sessions.
Primary Outcome Measure
Feasibility and acceptability of LIFT intervention components [ Time Frame: At the completion of the study of the individual's exercise and counseling program. ]
Central Contacts
- Jessica Gonzalez-Voller, Ph.D970-491-6289
- Heather Leach, Ph.D970-491-8951
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Colorado State Univerisity | Fort Collins | Colorado | 80538 |
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