Recruiting

Physical Activity

Sponsor:

University of Oklahoma

Code:

NCT06725953

Conditions

Cancer Survivorship

Chemotherapy Side Effects

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Cancer Survivorship

Chemotherapy Side Effects

Study ID

NCT06725953

Start date

Mar 10, 2025

Status verified date

Apr, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥18 years old
2. ability to speak/read English
3. ability to provide informed consent
4. underwent treatment within the last three years for a non-central nervous system-related cancer with said treatment having included chemotherapy
5. self-reported cognitive difficulties following cancer treatment
6. For CS+T2D: current T2D diagnosis as classified by a fasted blood glucose of ≥126 mg/dL, 2-hour oral glucose tolerance test of ≥200 mg/dL, HbA1c level of ≥6.5%, or use of medications to treat hyperglycemia (e.g., Metformin) or For CS: no current T2D diagnosis as classified by a fasted blood glucose <100 mg/dL, 2-hour oral glucose tolerance test <140 mg/dL, or HbA1c level of <5.7%. Presence/absence of T2D to be confirmed preferentially via physician's documentation
7. own smartphone and/or computer with internet access
8. willing to participate in the 12-week remotely-delivered PA program

Exclusion Criteria:

1. 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. We will define 2017 PAR-Q+ scores as indicating that PA may potentially be unsafe as responding "Yes" to any of the follow-up questions except \[1\] if the individual indicates that they have high blood pressure but subsequent responses indicate that they do not have problems keeping it under control and that their resting blood pressure is less than 160/90 mmHg, and \[2\] if the individual indicates that they have a metabolic condition but subsequent responses indicate that they do not have problems controlling their blood sugar levels, do not any experience signs or symptoms of hypoglycemia, and do not have any signs of symptoms of listed diabetes complications)
2. 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
3. currently a prisoner, pregnant, or planning to become pregnant during study.

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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 ]
  • Cerebrovascular Resistance [ Time Frame: Baseline and After Study Week 12 ]
  • Cerebrovascular Conductance [ Time Frame: Baseline and After Study Week 12 ]
  • Cerebrovascular Pulsatility [ Time Frame: Baseline and After Study Week 12 ]
  • Dynamic Cerebral Autoregulation [ Time Frame: Baseline and After Study Week 12 ]
  • Cognitive Function [ Time Frame: Baseline and After Study Week 12 ]

Central Contacts and Locations

Central contacts

Zachary C Pope, PhD

405-271-8001zachary-pope@ouhsc.edu

Mikhail Kellawan, PhD

405-325-5211kellawan@ou.edu

Locations

University of Oklahoma Health Sciences

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Zachary C Pope, PhD

208-891-9421zachary-pope@ouhsc.edu

Mikhail Kellawan, PhD

kellawan@ou.edu

Principal Investigator:

Zachary C Pope, PhD

More Information

Sponsor

University of Oklahoma

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Aerobic Physical Activity
  • Resistance Training
  • Wearable Devices
  • Smartphone Applications
  • Cancer Survivors
  • Chemo-Brain
  • Health Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-05-01.