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Stepped Care Cognitive Behavioral TherapyLIFTNCT07223346

Latinas Integrating Fitness and Therapy

A study testing Stepped Care Mental Health Counseling and Exercise Program in people with Stepped Care Cognitive Behavioral Therapy and Exercise, run by Colorado State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Stepped Care Mental Health Counseling and Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Oct 2025to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Gonzalez-Voller, Ph.D contact

970-491-6289

JESSICA.GONZALEZ2@COLOSTATE.EDU

Heather Leach, Ph.D contact

970-491-8951

Heather.Leach@colostate.edu

United States1 site, 1 recruiting

  • Colorado State Univerisity

    Fort Collins, Colorado, 80538

    Jessica Gonzalez-Voller, PhD, (970)-491-6289, JESSICA.GONZALEZ2@COLOSTATE.EDU

    Recruiting

Other trials in United States

About this study

Official title: Latinas Integrating Fitness and Therapy (LIFT)

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.

Read the 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.

Being tested
Stepped Care Mental Health Counseling, Exercise Program
Keywords
Latina cancer survivors, Mental health counseling, Stepped-care, Exercise, Physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stepped Care Mental Health CounselingBehavioural

    Also called AYUDA

    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 ProgramBehavioural

    Also called FitCancer

    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.

Study groups in NCT07223346
Study groupRoleWhat they receive
Combining exercise program and stepped-care counselingExperimentalInvestigators 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.
Receives: Behavioral: Stepped Care Mental Health Counseling; Behavioral: Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and acceptability of LIFT intervention components

    Feasibility will include the rate of recruitment, participant retention, and completeness of data. Acceptability, among participants (i.e., cancer survivors) will be assessed via survey and focus groups.

    Measured: At the completion of the study of the individual's exercise and counseling program.

Secondary outcomes (4)

  1. Patient-Reported Outcomes Measurement Information System (PROMIS)

    The PROMIS short forms for depression and anxiety are used to measure how often a person has felt symptoms such as sadness, worry, or nervousness during the past 7 days. Each form includes 8 questions with answers ranging from 1 ("Never") to 5 ("Always"). Scores can range from 8 to 40, with higher scores meaning more depression or anxiety symptoms.

    Measured: Administered at baseline, week 2, 6, and 10.

  2. Functional Assessment of Cancer Therapy -General (FACT-G)

    The FACT-G is a 27-item questionnaire used to assess health-related quality of life in people with cancer. It includes four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). Scores for each subscale are calculated by adding the responses, with adjustments made for any missing items. These subscale scores are then combined to produce a total FACT-G score. The total score ranges from 0 to 108, with PWB, SWB, and FWB each ranging from 0-28, and EWB ranging from 0-24. Higher scores indicate a better quality of life.

    Measured: Administered at baseline and week 10.

  3. Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Description: The GLTEQ is a self-reported questionnaire used to assess the frequency and duration of aerobic and strength-based physical activity during leisure time over the past month. Participants report how many days per week and how many minutes per session they engage in light, moderate, and vigorous aerobic exercise, as well as strength or resistance training. Only sessions lasting 10 minutes or more and performed during free time are included. The questionnaire also asks about the average time spent sitting on weekdays. Moderate-to-vigorous physical activity (MVPA) and moderate-to-vigorous physical activity including resistance and aerobic activities (MVPA R+A) are calculated by combining the frequency and duration of moderate and vigorous sessions. Higher values indicate greater physical activity.

    Measured: Administered at baseline and week 10.

  4. International Physical Activity Questionnaire (IPAQ)

    The IPAQ Short Form is a self-reported questionnaire that assesses physical activity levels over the previous 7 days. It asks about the frequency and duration of vigorous activity, moderate activity, walking, and sedentary behavior. Participants report the number of days they engaged in each activity for at least 10 minutes at a time, along with the hours and minutes spent on those days. These responses can be combined into a total number of minutes per week to represent overall physical activity (for example, 3 hours equal to 180 minutes) or reported as hours and minutes (for example, 2 hours and 20 minutes). Sedentary behavior is measured separately by asking about total sitting or lying down time on a typical weekday, also recorded in hours and minutes. Scores range from 0 minutes per week with no maximum limit, and higher scores indicate greater physical activity.

    Measured: Administered at baseline and week 10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2025
  2. Study start1 Oct 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223346
Sponsor's protocol ID
6710
Other IDs
Pilot Grant
Acronym
LIFT
Status last verified
Oct 2025
First submitted
25 Jul 2025
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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

Questions about this trial

What is this clinical trial studying?

A study testing Stepped Care Mental Health Counseling and Exercise Program in people with Stepped Care Cognitive Behavioral Therapy and Exercise, run by Colorado State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Gonzalez-Voller, Ph.D (970-491-6289, JESSICA.GONZALEZ2@COLOSTATE.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07223346, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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