Remote Physical Activity Programming to Improve Outcomes in Cancer Survivors With and Without Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Social Cognitive Theory-based, Technology-delivered Physical Activity Program
BehavioralParticipants 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.
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: Social Cognitive Theory-based, Technology-delivered Physical Activity ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Middle Cerebral Artery Velocity
We will complete transcranial doppler assessments to measure middle cerebral artery velocity at rest and during exercise.
Time frame
Baseline and After Study Week 122
Cerebrovascular Resistance
We will complete transcranial doppler assessments to measure cerebrovascular resistance at rest and during exercise.
Time frame
Baseline and After Study Week 123
Cerebrovascular Conductance
We will complete transcranial doppler assessments to measure cerebrovascular conductance at rest and during exercise.
Time frame
Baseline and After Study Week 124
Cerebrovascular Pulsatility
We will complete transcranial doppler assessments to measure cerebrovascular pulsatility at rest and during exercise.
Time frame
Baseline and After Study Week 12Secondary outcomes
1
Blood Pressure
After five minutes of quiet seated rest, we will take blood pressure measurements in triplicate using an blood pressure cuff around the left arm, with readings separated by 30-second breaks and the lowest two blood pressure readings averaged.
Time frame
Baseline and After Study Week 122
Body Mass Index
Body weight and height will be measured using a digital weight scale and stadiometer, respectively, while participants wear disposable hospital gowns. These measurements will be used to calculate body mass index.
Time frame
Baseline and After Study Week 123
Waist-to-Hip Ratio
Waist and hip circumference will be assessed per established standards. These measurements will be used to calculate waist-to-hip ratio.
Time frame
Baseline and After Study Week 124
Cholesterol Levels
We will complete blood draws to discern cholesterol levels, including high- and low-density lipoprotein and total cholesterol. Reporting these cholesterols simultaneously is commonplace.
Time frame
Baseline and After Study Week 12Other outcomes
1
Self-Efficacy for Physical Activity
Self-efficacy will be assessed using a 9-item measure from Rodgers et al. Participants will note their confidence during different physical activity-related situations ('0%: Not confident at all' to '100%: Extremely confident'; 10% increments).
Time frame
Baseline, After Study Week 6, and After Study Week 122
Social Support for Physical Activity
Social support will be evaluated using the Social Support and Exercise Survey, with participants reporting frequency of physical activity support over the last three months from family and, separately, friends ('1: None' to '5: Very often').
Time frame
Baseline, After Study Week 6, and After Study Week 123
Enjoyment of Physical Activity
Physical activity-related enjoyment will be measured via the 18-item Physical Activity Enjoyment Scale, with feelings related to physical activity-related statements/situations reported on a 7-point scale (varied response options).
Time frame
Baseline, After Study Week 6, and After Study Week 124
Barriers to Physical Activity
We will use a 14-item scale to assess agreement between hypothetical physical activity barriers and participants' perceived barriers ('1: Strongly disagree' to '4: Strongly agree').
Time frame
Baseline, After Study Week 6, and After Study Week 12Sponsors and contacts
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Source ClinicalTrials.gov