NCT07223346

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2025May 2027

First Submitted

Initial submission to the registry

July 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

July 25, 2025

Last Update Submit

October 29, 2025

Conditions

Keywords

Latina cancer survivorsMental health counselingStepped-careExercisePhysical activity

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Patient-Reported Outcomes Measurement Information System (PROMIS)

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

  • Functional Assessment of Cancer Therapy -General (FACT-G)

    Administered at baseline and week 10.

  • Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Administered at baseline and week 10.

  • International Physical Activity Questionnaire (IPAQ)

    Administered at baseline and week 10.

Study Arms (1)

Combining exercise program and stepped-care counseling

EXPERIMENTAL

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.

Behavioral: Stepped Care Mental Health CounselingBehavioral: Exercise Program

Interventions

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.

Also known as: AYUDA
Combining exercise program and stepped-care counseling

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.

Also known as: FitCancer
Combining exercise program and stepped-care counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State Univerisity

Fort Collins, Colorado, 80538, United States

RECRUITING

Related Publications (3)

  • 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: 30739169BACKGROUND
  • 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: 37974897BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jessica Gonzalez-Voller, Ph.D

    Colorado State University

    PRINCIPAL INVESTIGATOR
  • Heather Leach, Ph.D

    Colorado State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Gonzalez-Voller, Ph.D

CONTACT

Heather Leach, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 25, 2025

First Posted

October 31, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

October 31, 2025

Record last verified: 2025-10

Locations