Recruiting

Counseling & ExerciseLatinas Integrating Fitness and Therapy

Sponsor:

Colorado State University

Code:

NCT07223346

Conditions

Stepped Care Cognitive Behavioral Therapy

Exercise

Physical Activity

Anxiety Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stepped Care Mental Health Counseling

Exercise Program

Study Details

Brief summary:

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.

Conditions

Stepped Care Cognitive Behavioral Therapy

Exercise

Physical Activity

Anxiety Depression

Study ID

NCT07223346

Start date

Oct 1, 2025

Status verified date

Oct, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria: 1) currently undergoing or within 6-months of completing primary cancer(s) (2) self-identify as Latina and female, (3) over the age of 18 years, (4) reside in Colorado, (4) have access to internet, and be (5) English or Spanish speaking.

Exclusion Criteria: (1) metastatic disease, (2) known contraindications for exercise (e.g. existing CVD or metabolic disease, use of an assistive-walking device, severe ataxia, etc.), (3) part of a vulnerable population (pregnant, homeless, in prison, have auditory impairment), and (4) currently participating in mental health counseling with a licensed professional and/or a structured exercise program.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Combining exercise program and stepped-care counseling

Investigators 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.

Interventions

Stepped Care Mental Health Counseling

Counseling 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

The 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.

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 and Locations

Central contacts

Jessica Gonzalez-Voller, Ph.D

970-491-6289 JESSICA.GONZALEZ2@COLOSTATE.EDU

Heather Leach, Ph.D

970-491-8951 Heather.Leach@colostate.edu

Locations

Colorado State Univerisity

Recruiting

Fort Collins, Colorado, United States, 80538

Contacts

Jessica Gonzalez-Voller, PhD

(970)-491-6289 JESSICA.GONZALEZ2@COLOSTATE.EDU

More Information

Sponsor

Colorado State University

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

Latina cancer survivors
Mental health counseling
Stepped-care
Exercise
Physical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2025-10-31.