Remote physical activity program for cancer survivors with and without diabetes
Cerebrovascular, Cognitive, Pro-Inflammatory, and Cardiometabolic Outcomes in Cancer Survivors With and Without Type II Diabetes Reporting Chemo-Brain: Baseline Differences and Impact of Activity
This study is trying out a remote exercise program for cancer survivors, with and without diabetes, to see if it can help improve their quality of life and cognitive skills after chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT06725953 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the quality of life for cancer survivors, particularly those experiencing cognitive difficulties after chemotherapy, by implementing a remote physical activity program. The program is based on Social Cognitive Theory and utilizes technology, such as wearable devices and smartphone applications, to encourage aerobic and resistance training. Participants will engage in a 12-week program designed to address the cognitive impairments associated with chemotherapy and the comorbidities of type 2 diabetes. The study will assess the effectiveness of this intervention in enhancing physical activity levels and overall health outcomes for cancer survivors.
Who should consider this trial
Good fit: Ideal candidates include cancer survivors aged 18 and older who have experienced cognitive difficulties following chemotherapy and may or may not have a diagnosis of type 2 diabetes.
Not a fit: Patients who have not undergone chemotherapy or do not experience cognitive difficulties post-treatment may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life and cognitive function for cancer survivors, particularly those with type 2 diabetes.
How similar studies have performed: While there is ongoing research in this area, this specific approach combining remote physical activity programming with a focus on cognitive impairment in cancer survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Zachary C Pope, PhD — University of Oklahoma Health Sciences
- Study coordinator: Zachary C Pope, PhD
- Email: zachary-pope@ouhsc.edu
- Phone: 405-271-8001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.