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

NCT06725953 | Recruiting

• 2 other identifiers: 17332PHR23-061-2
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Middle Cerebral Artery Velocity

  We will complete transcranial doppler assessments to measure middle cerebral artery velocity at rest and during exercise.

  Baseline and After Study Week 12

• Cerebrovascular Resistance

  We will complete transcranial doppler assessments to measure cerebrovascular resistance at rest and during exercise.

  Baseline and After Study Week 12

• Cerebrovascular Conductance

  We will complete transcranial doppler assessments to measure cerebrovascular conductance at rest and during exercise.

  Baseline and After Study Week 12

• Cerebrovascular Pulsatility

  We will complete transcranial doppler assessments to measure cerebrovascular pulsatility at rest and during exercise.

  Baseline and After Study Week 12

• Dynamic Cerebral Autoregulation

  We will assess dynamic cerebral autoregulation using the Thigh Cuff Release Challenge technique. Large bilateral blood pressure thigh cuffs are rapidly inflated (rapid cuff inflation/deflation system) to occlude the lower limbs. Blood flow will be monitored in the dorsalis pedis artery, and the initial thigh cuff pressure will start at 20 mmHg above systolic blood pressure. If blood flow is still detected, thigh cuff pressure will increase gradually until occlusion is confirmed. The occlusion will be held for 2 min. After 2 min of occlusion, the cuff pressure is rapidly deflated.

  Baseline and After Study Week 12

• Cognitive Function

  We will assess cognitive function using the NIH Toolbox-a platform for low-burden, standardized delivery of cognitive function testing. We will employ the NIH Toolbox Cognitive Battery to obtain a Fluid Composite score from all or some of the following five tests: 1) Dimensional Change Card Sort \[executive function\]; 2) Pattern Comparison Processing Speed; 3) List Sorting Working Memory; 4) Flanker Inhibitory Control and Attention; and/or 5) Picture Sequencing Memory. We will score tests per established standards used in other studies employing NIH Toolbox.

  Baseline and After Study Week 12

Secondary Outcomes (7)

• Blood Pressure

  Baseline and After Study Week 12

• Body Mass Index

  Baseline and After Study Week 12

• Waist-to-Hip Ratio

  Baseline and After Study Week 12

• Cholesterol Levels

  Baseline and After Study Week 12

• Fasting Blood Glucose

  Baseline and After Study Week 12

Other Outcomes (12)

• Self-Efficacy for Physical Activity

  Baseline, After Study Week 6, and After Study Week 12

• Social Support for Physical Activity

  Baseline, After Study Week 6, and After Study Week 12

• Enjoyment of Physical Activity

  Baseline, After Study Week 6, and After Study Week 12

Study Arms (1)

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

EXPERIMENTAL

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• ability to speak/read English
• ability to provide informed consent
• underwent treatment within the last three years for a non-central nervous system-related cancer with said treatment having included chemotherapy
• self-reported cognitive difficulties following cancer treatment
• 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
• own smartphone and/or computer with internet access
• willing to participate in the 12-week remotely-delivered PA program

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (1)

• Pope ZC, Yabluchanskiy A, Mukli P, Robertson MC, Oliver JA, Borengasser SJ, Ratke MM, Matney JE, Mixon C, Henson C, Kellawan JM. Smartphone-Based Physical Activity Program to Reduce "Chemo-Brain" Symptoms and Improve Health in Cancer Survivors With and Without Type 2 Diabetes: Protocol for a Single-Arm Pre-Post Pilot Trial. JMIR Res Protoc. 2025 Dec 10;14:e79739. doi: 10.2196/79739.

  PMID: 41370824 DERIVED

Study Officials

• Zachary C Pope, PhD

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

• Mikhail Kellawan, PhD

  University of Oklahoma, Department of Health and Exercise Science

  PRINCIPAL INVESTIGATOR

• Andriy Yabluchanskiy, MD, PhD

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary C Pope, PhD

CONTACT

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

Mikhail Kellawan, PhD

CONTACT

405-325-5211; kellawan@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Social Cognitive Theory-based, Technology-delivered Physical Activity Program

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: March 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)