Remote Physical Activity Programming to Improve Outcomes in Cancer Survivors With and Without Type 2 Diabetes

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06725953
Status
Recruiting
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Conditions

  • Cancer Survivorship
  • Chemotherapy Side Effects

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome Measure

Middle Cerebral Artery Velocity [ Time Frame: Baseline and After Study Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health SciencesOklahoma CityOklahoma73104
Zachary C Pope, PhD
[email protected]
208-891-9421
Mikhail Kellawan, PhD
[email protected]
Zachary C Pope, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Oklahoma Health Sciences· Oklahoma City, OK

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