Latinas Integrating Fitness and Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColorado State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Combining exercise program and stepped-care counselingExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
At the completion of the study of the individual's exercise and counseling program.Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Administered at baseline and week 10.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Colorado State University
Lead sponsor
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov