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Completed

NCT Number: NCT06016725

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

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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Rectal Diseases 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 Urogenital Diseases Urogenital Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise intervention

Other

Participate in online resistance training sessions

Informational intervention

Other

Given educational materials

Nutritional Assessment

Other

Participate in online nutritional counseling

Other names: Dietary Assessment, dietary counseling, nutritional counseling

Physical Performance Testing

Other

Ancillary studies

Other names: Physical Fitness Testing, Physical Function Testing

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Anthropometry Height in Inches

    Time frame: end-of-intervention, at 12 weeks

    At end-of-intervention, participants' height was assessed using height in centimeters.

  13. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: E-PROOF

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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