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

NCT06016725 | Completed Results DMC

• 3 other identifiers: OSU-22329NCI-2023-04622R21AG078258
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Physical Function at End-of-intervention

  Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention.

  end-of-intervention, at 12 weeks

Secondary Outcomes (13)

• Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions

  end-of-intervention, at 12 weeks

• Study Accrual Rate

  assessed during the 12 month recruitment period

• Study Retention Rate

  End-of-study, up to 3 months

• Study Adherence Rate

  end-of-intervention, at 12 weeks

• Grip Strength

  end-of-intervention, at 12 weeks

Study Arms (2)

Arm 1 (nutritional counseling, resistance training)

EXPERIMENTAL

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.

Other: Exercise Intervention; Other: Informational Intervention; Other: Nutritional Assessment; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm 2 (educational materials)

ACTIVE COMPARATOR

Patients receive educational materials at baseline.

Other: Informational Intervention; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Exercise Intervention OTHER

Participate in online resistance training sessions

Arm 1 (nutritional counseling, resistance training)

Informational Intervention OTHER

Given educational materials

Arm 1 (nutritional counseling, resistance training); Arm 2 (educational materials)

Nutritional Assessment OTHER

Participate in online nutritional counseling

Also known as: Dietary Assessment, dietary counseling, nutritional counseling

Arm 1 (nutritional counseling, resistance training)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Arm 1 (nutritional counseling, resistance training); Arm 2 (educational materials)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm 1 (nutritional counseling, resistance training); Arm 2 (educational materials)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (nutritional counseling, resistance training); Arm 2 (educational materials)

Eligibility Criteria

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

You may qualify if:

• \>= 65 years of age
• A primary diagnosis of stage I-III breast, colorectal, and prostate cancer
• Completion of primary curative treatment
• Reported at least 1 physical function limitation on the RAND-36 Physical Function Subscale (PFSS) ("limited a little", "limited a lot")
• No evidence of progressive disease or second cancers
• Community-dwelling
• Able to provide consent

You may not qualify if:

• Currently receive cancer treatment (e.g., chemotherapy, radiation)
• Have liver and/or renal disease limiting their protein intake
• Are under the care of a Registered Dietician (RD)/nutritionist
• Participating in other diet/exercise interventions
• Consume protein supplements
• Have contraindications to unsupervised exercise (e.g., walker/wheelchair use)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Colorectal Neoplasms; Prostatic Neoplasms

Interventions

Nutrition Assessment; Exercise Test

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Results Point of Contact

• Title: Dr. Jessica Krok-Schoen, Associate Professor
• Organization: School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University

Jessica.krok@osumc.edu

8133686470

Study Officials

• Jessica L Krok-Schoen, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 30, 2023
• Study Start: August 28, 2023
• Primary Completion: October 31, 2024
• Study Completion: June 5, 2025
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)