NCT06016725

Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial

E-PROOF: E-Intervention for Protein Intake and Resistance Training to Optimize Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.

Detailed description

PRIMARY OBJECTIVES: I. Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance training randomized trial with 70 older cancer survivors. II. Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with the intervention participants. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline. ARM 2: Patients receive educational materials at baseline. After completion of study intervention, patients are followed up at 3 months.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Stage I Colorectal Cancer AJCC v8
• Stage I Prostate Cancer AJCC v8
• Stage II Colorectal Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Exercise Intervention	Participate in online resistance training sessions
OTHER	Informational Intervention	Given educational materials
OTHER	Nutritional Assessment	Participate in online nutritional counseling
OTHER	Physical Performance Testing	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-08-28
• Primary completion: 2024-10-31
• Completion: 2025-06-05
• First posted: 2023-08-30
• Last updated: 2026-01-02
• Results posted: 2026-01-02

Locations

1 site across 1 country: United States