Nutrition & Exercise Prehabilitation for Cancer Patients
This study is looking at a 3-week program for American Indian cancer patients before they start their main cancer treatment. The program involves eating 60 grams of walnuts daily and doing two 60-minute supervised exercise sessions each week. Researchers want to see if this program is practical and acceptable to patients, and if it can change certain inflammatory markers (signs of inflammation in the body) in their blood and tissue. You can join if you are 18-80 years old, have any type of cancer, are scheduled for treatment at least 3 weeks away, receive care at San Carlos Apache Healthcare Corporation (SCAHC), can eat walnuts, and can do moderate exercise. The study is currently recruiting about 30 participants.
- Study design
- This is a single-arm study, meaning everyone receives the same intervention, and plans to enroll 30 participants.
- What's involved
- You would participate in a 3-week program involving daily walnut consumption and two weekly supervised exercise sessions, along with baseline and post-intervention measurements including blood samples.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements are taken at baseline and post-intervention (an average of 5 weeks), with adherence to the protocol measured for 3 weeks.
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A Nutrition & Exercise Prehabilitation Intervention on Inflammatory Biomarkers in AI Cancer Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jennifer Erdrich, MD · PRINCIPAL_INVESTIGATOR · University of Arizona
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Patient enrollment and retention: proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurementsBaseline and post-intervention (an average of 5 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via patient enrollment and retention. Patient retention will be estimated as the proportion of patients who initiate the intervention, provide pre-intervention measurements and return for post-intervention measurements, with an exact 95% binomial confidence interval.
- Adherence to study protocol: compliance with intervention foods (walnuts)3 weeks during participant's preoperative window
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with intervention foods (walnuts). Compliance with intervention foods (walnuts) will be estimated as the number of daily packets eaten/number distributed, with an exact 95% binomial confidence interval.
- Adherence to study protocol: compliance with exercise recommendations3 weeks during participant's preoperative window
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via compliance with exercise recommendations. Compliance with exercise recommendations will be estimated as the increase in daily steps (as measured by pedometers) post- versus pre-intervention using a 95% confidence interval.
- Assessing patient acceptability via exit interviews to solicit patient experience and feedback3 weeks during participant's post-intervention assessment
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring patient reported acceptability via exit interviews. The exit interviews will provide qualitative data for assessment. The interview transcriptions will be coded and themed. Themes will be vetted with SCAHC staff to ensure shared understanding of concepts and accurate representation of community perspective.
- Comparison of pre/post-intervention 6 Minute Walk Test Scores to assess lifestyle behavioral changeBaseline and post-intervention assessment (an average of 3 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the 6 Minute Walk Test scores. The score of the 6MWT is the distance a patient walks in 6 minutes. Pre/post intervention performance changes on the 6MWT will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
- Comparison of pre/post-intervention sit-to-stand test scores to assess lifestyle behavioral changeBaseline and post-intervention assessment (an average of 3 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via the sit-to-stand test scores. The sit-to-stand test score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Pre/post intervention performance changes on the sit-to-stand test will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
- Comparison of pre/post-intervention patient responses to the Dietary Screener QuestionnaireBaseline and post-intervention assessment (an average of 3 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing pre/post- intervention responses to the Dietary Screener Questionnaire. The Dietary Screener Questionnaire has 30 questions. There is a scoring algorithm that converts the responses to estimates of dietary intake of fruits and vegetables, dairy, added sugar, whole grain, fiber, and calcium. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
- Comparison of pre/post-intervention patient responses to the Arizona Activity QuestionnaireBaseline and post-intervention assessment (an average of 3 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by measuring lifestyle behavioral changes via comparing Arizona Activity Questionnaire. The Arizona Activity Questionnaire has 14 sections with 77 line items. There is a formula that converts the responses to estimates of total energy expenditure and physical activity energy expenditure. Changes between pre and post intervention will be estimated using 95% confidence intervals, with transformation as needed to induce normality.
- Assessing biosample collection rates: percentage of patients completing blood and tissue sample collectionBaseline and post-intervention assessment (an average of 3 weeks)
Primary endpoint: determining feasibility of the prehabilitation intervention by assessing percentage of patients who complete blood and tissue sample collections. Biosample collection rates (plasma and tissue) will be estimated as the proportion of patients who provide biospecimens at the pre- and post-intervention visits, with exact 95% binomial confidence intervals.