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

December 11, 2025 updated by: Jessica Krok-Schoen, Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >= 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (nutritional counseling, resistance training)
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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Exercise Intervention
Participate in online resistance training sessions
Other: Informational Intervention
Given educational materials
Other: Nutritional Assessment
Participate in online nutritional counseling
Other Names:
  • dietary counseling
  • Dietary Assessment
  • nutritional counseling
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Active Comparator: Arm 2 (educational materials)
Patients receive educational materials at baseline.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Informational Intervention
Given educational materials
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Function at End-of-intervention
Time Frame: end-of-intervention, at 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions
Time Frame: end-of-intervention, at 12 weeks
Percentage of participant satisfaction ("satisfied" and "very satisfied") measured by a 5-item Likert-scale questionnaire. Scores range from 1-5, with 5 being the highest score of satisfaction.
end-of-intervention, at 12 weeks
Study Accrual Rate
Time Frame: assessed during the 12 month recruitment period
Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures.
assessed during the 12 month recruitment period
Study Retention Rate
Time Frame: End-of-study, up to 3 months
calculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported.
End-of-study, up to 3 months
Study Adherence Rate
Time Frame: end-of-intervention, at 12 weeks
Participants were determined to be adherent if they attend >= 80% of the online intervention sessions. Overall adherence rates and associated 95% confidence intervals were reported.
end-of-intervention, at 12 weeks
Grip Strength
Time Frame: end-of-intervention, at 12 weeks
Handgrip strength (absolute value at the end of the intervention) was measured in both hands using a hydraulic grip strength dynamometer. This is measured in kgs.
end-of-intervention, at 12 weeks
Dietary Quality
Time Frame: end-of-intervention, at 12 weeks
Dietary quality was assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Absolute value at end-of-intervention was assessed using the Healthy Eating Index score.
end-of-intervention, at 12 weeks
Percentage of Participants Who Completed Resistance Exercises
Time Frame: end-of-intervention, at 12 weeks
Self-reported resistance exercise (% yes) was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. If a participant denoted "yes" to the question: did During a typical 7-Day period (a week), did you participate in resistance exercise for more than 15 minutes during your free time? Percentages denote the percentage of the study subjects who participated in resistance training at end of intervention.
end-of-intervention, at 12 weeks
Health-related Quality of Life (HRQoL)
Time Frame: end-of-intervention, at 12 weeks
RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. All scores range from 0-100, with 100 as the highest HRQoL. The main HRQoL subscale reported is the general health HRQoL subscale. Mean scores of general HRQoL for end-of-intervention are reported.
end-of-intervention, at 12 weeks
Self-efficacy
Time Frame: end-of-intervention, at 12 weeks
Self-efficacy was measured at the end of intervention via a 0-10 confidence scale rating the confidence of making exercise and diet changes in one's life, with 0 meaning not confident, 10 meaning very confident.
end-of-intervention, at 12 weeks
Technology Competency
Time Frame: end-of-intervention, at 12 weeks
The 8-item eHealth Literacy Scale measured knowledge, comfort, and perceived skills of engaging in eHealth at end-of-intervention. A 5-point Likert scale was used, with possible scores ranging from 8 to 40. Higher scores indicate higher ehealth literacy.
end-of-intervention, at 12 weeks
Anthropometry Body Weight in Kilograms
Time Frame: end-of-intervention, at 12 weeks
At end-of-intervention, participant's body weight was assessed in kilograms.
end-of-intervention, at 12 weeks
Anthropometry Height in Inches
Time Frame: end-of-intervention, at 12 weeks
At end-of-intervention, participants' height was assessed using height in centimeters.
end-of-intervention, at 12 weeks
Anthropometry Measuring Waist Circumference in Centimeters
Time Frame: end-of-intervention, at 12 weeks
At end-of-intervention, participants' waist circumference was assessed in centimeters.
end-of-intervention, at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Jessica L Krok-Schoen, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

June 5, 2025

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-22329
  • NCI-2023-04622 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R21AG078258 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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