Physical Activity Program for Cancer Survivors

(CICI-PA Trial)

Overseen By Mikhail Kellawan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must be taking: Metformin

Disqualifiers: High PA, Pregnancy, Prisoner, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

38 Participants Needed

Trial Summary

What is the purpose of this trial?

The growing U.S. cancer survivor population is projected to hit 26M by 2040. Chemotherapy represents an effective cancer treatment but can diminish cancer survivors' quality of life-particularly cognitive function-through select pathophysiological processes. Research on chemotherapy-induced cognitive impairment (hereafter, 'chemo-brain') is therefore critical. Chemotherapy disrupts immune system function and antioxidant regulation, causing inflammatory molecule release and damaging the brain's blood vessels. The brain's vascular function and, possibly, its neurons, are subsequently impaired-likely contributing to chemo-brain. Type 2 diabetes (T2D), a common cancer survivor comorbidity, shares underlying pathophysiology with chemo-brain. T2D-related insulin resistance can precipitate repeated high blood sugar episodes which increase inflammatory molecule release. In individuals with T2D without cancer, negative relationships are observed between inflammatory molecule concentrations and the brain's vascular and/or cognitive function. Cancer survivors with T2D might thus have higher chemo-brain risk than those without T2D. Yet, more research must compare how the brain's vascular function, as well as cognitive, inflammatory, and cardiometabolic indices, differ between these groups. Physical activity (PA) counteracts chemo-brain's and T2D's pathophysiology, with higher PA/fitness resulting in better vascular function of the brain, lower inflammatory molecule concentrations, and improved insulin sensitivity. We are therefore conducting a 30-participant quasi-experimental pilot study in cancer survivors with (cases) and without (controls) T2D. We will first investigate between-group differences in the brain's vascular function as well as cognitive, inflammatory, cardiometabolic, and epigenetic outcomes. We will then examine between-group changes in these outcomes and select psychosocial metrics during a 12-week technology-based PA program-potentially further elucidating involved mechanisms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have Type 2 diabetes, you may continue using medications to treat hyperglycemia (high blood sugar).

What data supports the effectiveness of the treatment Social Cognitive Theory-based, Technology-delivered Physical Activity Program for cancer survivors?

Research shows that programs based on social cognitive theory (SCT) can help increase physical activity in cancer survivors. For example, the ENRICH trial found that an SCT-based intervention led to more steps taken by participants, and another study showed that reducing barriers to exercise helped maintain physical activity in breast cancer survivors. ^{1 2 3 4 5}

Is the Social Cognitive Theory-based, Technology-delivered Physical Activity Program safe for cancer survivors?

The studies suggest that physical activity programs based on social cognitive theory are generally safe for breast cancer survivors, with benefits like reduced fatigue and improved quality of life, and no significant safety concerns reported. ^{1 3 4 5 6}

How is the Social Cognitive Theory-based, Technology-delivered Physical Activity Program unique for cancer survivors?

This treatment is unique because it uses social cognitive theory (a framework for understanding behavior change) to motivate cancer survivors to increase their physical activity through a technology-delivered program. Unlike traditional treatments, it focuses on reducing barriers to exercise and enhancing enjoyment, which helps maintain long-term physical activity. ^{1 2 4 5 6}

Research Team

Andriy Yabluchanskiy, MD, PhD

Principal Investigator

University of Oklahoma Health Sciences

Mikhail Kellawan, PhD

Principal Investigator

University of Oklahoma, Department of Health and Exercise Science

Zachary C Pope, PhD

Principal Investigator

University of Oklahoma Health Sciences

Eligibility Criteria

This trial is for adults over 18 who've had non-CNS cancer treatment with chemotherapy in the last three years and are experiencing 'chemo-brain'. It includes those with Type 2 Diabetes (T2D) and without. Participants must speak/read English, give informed consent, own a smartphone/computer with internet, and be willing to join a 12-week remote physical activity program.

Inclusion Criteria

Ability to speak/read English

Ability to provide informed consent

Own smartphone and/or computer with internet access

Exclusion Criteria

Reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note

Engaging in ≥75 min/week of vigorous-intensity PA, ≥150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months

Currently a prisoner, pregnant, or planning to become pregnant during study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments of cerebrovascular, cognitive, pro-inflammatory, and cardiometabolic outcomes

1 week

1 visit (in-person)

Treatment

Participants engage in a 12-week technology-delivered physical activity program

12 weeks

Remote monitoring with periodic virtual check-ins

Follow-up

Participants are monitored for changes in health outcomes post-treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Social Cognitive Theory-based, Technology-delivered Physical Activity Program

Trial Overview The study tests a technology-delivered physical activity program based on Social Cognitive Theory to see if it improves brain vascular function, cognitive abilities, inflammation levels, cardiometabolic health, and psychosocial metrics in cancer survivors with or without T2D.

Participant Groups

Group I: Social Cognitive Theory-based, Technology-delivered Physical Activity Program Experimental Treatment 1 Intervention

Participants will engage in a 12-week program of aerobic and muscle-strengthening physical activity. This program will be delivered remotely via two smartphone applications--one for providing health education, goal setting, and journaling features and the other for delivery of the physical activity program in a highly-personalized and HIPAA-compliant manner. Participants will receive a Fitbit to track their activity and resistance bands to use during their resistance training physical activity. All program components will be based in the Social Cognitive Theory and will target improving participants' physiological and psychological health outcomes.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

A pilot study showed that a physical activity behavior change intervention significantly improved physical activity levels and health outcomes among breast cancer survivors, indicating its potential effectiveness.

The upcoming two-site randomized controlled trial aims to recruit 256 breast cancer survivors to further assess the intervention's long-term effects and explore the mechanisms behind behavior change, with outcomes measured at multiple time points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. Rogers, LQ., McAuley, E., Anton, PM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Social cognitive theory and physical activity during breast cancer treatment. [2005]

2. England pubmed.ncbi.nlm.nih.gov

Predictors of exercise frequency in breast cancer survivors in Taiwan. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Exploring social cognitive theory constructs for promoting exercise among breast cancer patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Reduced barriers mediated physical activity maintenance among breast cancer survivors. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Social cognitive theory mediators of physical activity in a lifestyle program for cancer survivors and carers: findings from the ENRICH randomized controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. [2022]