Physical Activity Program for Cancer Survivors
(CICI-PA Trial)
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.12345
Is the Social Cognitive Theory-based, Technology-delivered Physical Activity Program safe for cancer survivors?
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.12456
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessments of cerebrovascular, cognitive, pro-inflammatory, and cardiometabolic outcomes
Treatment
Participants engage in a 12-week technology-delivered physical activity program
Follow-up
Participants are monitored for changes in health outcomes post-treatment
Treatment Details
Interventions
- Social Cognitive Theory-based, Technology-delivered Physical Activity Program
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor