Latinas Integrating Fitness and Therapy

Official title

Latinas Integrating Fitness and Therapy (LIFT)

Overview

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.

Detailed description

This study will be 10 weeks and offered online via Zoom. Participants can choose for their exercise and counseling sessions and materials to be in English or Spanish. If participants join they will: (1) Complete surveys at the beginning, 2 weeks, 6 weeks, and 10 weeks. These may consist of questions asking about levels of anxiety and depression, physical activity, and quality of life. (2) At week 1 and week 10, be asked to complete assessments of physical ability, which include muscular endurance and balance. (3) Participate in an 8-week evidence-based exercise program, which includes: one-hour exercise session 1 time per week and three, 30-minute discussion sessions to help them stay active after the study ends. (4) Receive one orientation meeting the counselor and up to seven one-hour individual counseling sessions with a counselor who will be supervised by a licensed therapist. The number of counseling sessions received will depend on their feelings or symptoms of anxiety or depression. If these symptoms are mild, they will receive fewer sessions. Counseling session will last approximately 1-hour and be online. (5) Counseling, exercise, and discussion sessions will be recorded for training purposes, but will keep identities private. (6) The total time commitment will be between 1-3 hours per week, for 8-weeks.

Interventions

• Behavioral 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. Th
• Behavioral 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 sess

Primary outcome measures

• Feasibility and acceptability of LIFT intervention components [Time frame: At the completion of the study of the individual's exercise and counseling program.]

Secondary outcome measures (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS) [Time frame: Administered at baseline, week 2, 6, and 10.]
• Functional Assessment of Cancer Therapy -General (FACT-G) [Time frame: Administered at baseline and week 10.]
• Godin Leisure-Time Exercise Questionnaire (GLTEQ) [Time frame: Administered at baseline and week 10.]
• International Physical Activity Questionnaire (IPAQ) [Time frame: Administered at baseline and week 10.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Colorado State Univerisity — Fort Collins

Publications

• Leach HJ, Mama SK, Harden SM. Group-based exercise interventions for increasing physical activity in cancer survivors: a systematic review of face-to-face randomized and non-randomized trials. Support Care Cancer. 2019 May;27(5):1601-1612. doi: 10.1007/s00520-019-04670-y. Epub 2019 Feb 9. PMID 30739169
• Leach HJ, Crisafio ME, Howell MJ, Nicklawsky A, Marker RJ. A Group-Based, Videoconference-Delivered Physical Activity Program for Cancer Survivors. Transl J Am Coll Sports Med. 2023 Spring;8(2):e000221. doi: 10.1249/tjx.0000000000000221. Epub 2023 Feb 10. PMID 37974897
• Gonzalez-Voller, J., Schumacher, A. R., Nguyen, J., Kilbourn, K., Okuyama, S., Fullwood, C. R., & Borrayo, E. A. (2025). The AYUDA Pilot-Study Intervention: Psychosocial Support for Underserved Spanish-Speaking Latinas Undergoing Breast Cancer Treatment. Hispanic Journal of Behavioral Sciences, 0(0). https://doi.org/10.1177/07399863251357733

Identifiers

NCT: NCT07223346 · 6710 · Pilot Grant

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗