Mental Health Counseling + Exercise for Cancer Survivors

(LIFT Trial)

Overseen By Heather Leach, Ph.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Colorado State University

Disqualifiers: Metastatic disease, CVD, metabolic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining a mental health counseling program with an exercise routine can improve the mental and physical well-being of Latina cancer survivors. The goal is to reduce stress and enhance emotions and activity levels during and after cancer treatment. Participants will join an online program and complete surveys to track changes in their mental health over time. If depression or anxiety symptoms increase, additional counseling will be provided. The trial seeks Latina women in Colorado who are currently undergoing cancer treatment or have completed it within the last six months.

As an unphased trial, it offers a unique opportunity to contribute to research that could enhance support for Latina cancer survivors.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on mental health counseling and exercise, so it's best to discuss your medications with the trial team.

What prior data suggests that this exercise program and mental health counseling are safe for Latina cancer survivors?

Research has shown that exercise programs and stepped-care mental health counseling are generally safe for everyone, including cancer survivors. Exercise programs can improve overall health, reduce body pain, and decrease fatigue without major safety concerns. One study found that exercise even increased survival rates for cancer patients.

Stepped-care counseling helps with depression and coping skills. It is particularly effective in managing symptoms like depression and fatigue in cancer patients. Previous studies have demonstrated that this type of mental health support can improve feelings of distress and quality of life.

Overall, both treatments are well-tolerated and have a history of safety for people dealing with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining exercise programs with stepped-care mental health counseling for cancer survivors because it offers a personalized and holistic approach to recovery. Unlike standard treatments that may focus solely on medical intervention, this approach integrates physical activity with mental health support, addressing both body and mind. The use of online platforms makes it accessible, especially for underserved populations like Latinas with cancer. By tailoring mental health interventions based on individual needs and monitoring progress through regular surveys, this method could significantly enhance the quality of life and emotional well-being for cancer survivors.

What evidence suggests that combining exercise and mental health counseling is effective for cancer survivors?

Research has shown that exercise programs can greatly benefit cancer survivors. One study found that participants in a structured exercise program had an 80% chance of remaining disease-free, compared to 74% for those who only received educational materials. Exercise also improved quality of life, reduced body pain, and lowered fatigue.

For mental health support, research suggests that stepped-care models, which adjust the level of care based on individual needs, can enhance mental health in cancer survivors. A review of 22 studies showed that these models effectively improved issues like depression and anxiety. Another study found that stepped-care approaches were more effective than standard care in improving mental health.

This trial will provide participants with a combination of an exercise program and stepped-care mental health counseling. Combining these two treatments could enhance both mental and physical well-being for Latina cancer survivors. ^{1 3 6 7 8}

Who Is on the Research Team?

Jessica Gonzalez-Voller, Ph.D

Principal Investigator

Colorado State University

Heather Leach, Ph.D

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

This trial is for Latina cancer survivors looking to improve their mental and physical well-being. Participants should be interested in a program that combines mental health counseling with an exercise regimen designed to help with stress, emotions, and physical activity during and after cancer treatment.

Inclusion Criteria

I speak English or Spanish.

Reside in Colorado

Have access to internet

Exclusion Criteria

My cancer has spread to other parts of my body.

Known contraindications for exercise (e.g. existing CVD or metabolic disease, use of an assistive-walking device, severe ataxia, etc.)

Part of a vulnerable population (pregnant, homeless, in prison, have auditory impairment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Treatment

Participants engage in an 8-week evidence-based exercise program and receive up to seven one-hour individual counseling sessions based on their symptoms of anxiety or depression.

8 weeks

1 visit per week (virtual)

Follow-up

Participants are monitored for changes in depression, anxiety, and physical activity levels through surveys and assessments.

2 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Program
• Stepped Care Mental Health Counseling

Trial Overview The study is testing the combination of stepped-care mental health counseling with an evidence-based exercise program. The aim is to see if this dual approach can enhance the emotional and physical state of Latina cancer survivors, while also assessing how practical and acceptable it is for them.

How Is the Trial Designed?

Group I: Combining exercise program and stepped-care counseling Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4821160/

Community-based exercise program effectiveness and ... Participants reported improvements in overall health-related quality of life (P< 0.001), social support (P=0.019), body pain (P=0.016), fatigue (P<0.001), ...

2. asco.org asco.org/about-asco/press-center/news-releases/movement-medicine-structured-exercise-program-challenge

Structured Exercise Program May Lower Risk of Cancer ... At five years, the disease-free survival rate was 80% in the structured exercise program and 74% in the health education materials group.

3. accc-cancer.org accc-cancer.org/docs/documents/oncology-issues/articles/2024/v39-n5/how-one-community-exercise-program-for-people-living-with-cancer-impacted-health-care-utilization.pdf

how-one-community-exercise-program-for-people-living- ... Exercise is known to help with short-term outcomes, but less is known about long-term outcomes. This retrospective study based on administrative data included a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772696724000036

Interim results and program satisfaction of the EXCEL study Self-efficacy for continuing to exercise after EXCEL was moderate to high, as participants reported on average that they were 'somewhat' to 'quite a bit ...

5. frontiersin.org frontiersin.org/journals/cancer-control-and-society/articles/10.3389/fcacs.2024.1389084/full

Activating cancer communities through an exercise ... Average attendance to the program was 22.8 sessions (95%). 3.4 Outcomes to support implementation at the individual level. 3.4.1 Costs for participants.

6. ysph.yale.edu ysph.yale.edu/news-article/how-exercise-increases-cancer-survival/

How Exercise Increases Cancer Survival The overall survival was 90.3% in the exercise group versus 83.2% in the group that received educational materials alone. Dr. Melinda Irwin, PhD ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1040842824003457

Grading the evidence for physical activity and any outcome ... Strong, highly suggestive and suggestive evidence support the benefits of physical activity in many tumor types and outcomes.

8. bjsm.bmj.com bjsm.bmj.com/content/59/14/1010

Impact of exercise on health outcomes in people with cancer Conclusion Exercise reduces adverse events and enhances well-being through a range of health outcomes in people with cancer. Meta-analysis; Exercise; Randomised ...