Anatomic Stage I Breast Cancer AJCC v8E-PROOFNCT06016725
Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial
A study testing Exercise Intervention, Informational Intervention and Nutritional Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Exercise Intervention, Informational Intervention and Nutritional Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >= 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Being tested
- Exercise Intervention, Informational Intervention, Nutritional Assessment, Physical Performance Testing, Quality-of-Life Assessment
- Medical subject headings
- Colorectal Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participate in online resistance training sessions
Informational InterventionOther
Given educational materials
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Participate in online nutritional counseling
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Informational Intervention; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end-of-intervention, at 12 weeks
Secondary outcomes (13)
Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions
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.
Measured: end-of-intervention, at 12 weeks
Study Accrual Rate
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.
Measured: assessed during the 12 month recruitment period
Study Retention Rate
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.
Measured: End-of-study, up to 3 months
Study Adherence Rate
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.
Measured: end-of-intervention, at 12 weeks
Grip Strength
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.
Measured: end-of-intervention, at 12 weeks
Dietary Quality
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.
Measured: end-of-intervention, at 12 weeks
Percentage of Participants Who Completed Resistance Exercises
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.
Measured: end-of-intervention, at 12 weeks
Health-related Quality of Life (HRQoL)
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.
Measured: end-of-intervention, at 12 weeks
Self-efficacy
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.
Measured: end-of-intervention, at 12 weeks
Technology Competency
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.
Measured: end-of-intervention, at 12 weeks
Anthropometry Body Weight in Kilograms
At end-of-intervention, participant's body weight was assessed in kilograms.
Measured: end-of-intervention, at 12 weeks
Anthropometry Height in Inches
At end-of-intervention, participants' height was assessed using height in centimeters.
Measured: end-of-intervention, at 12 weeks
Anthropometry Measuring Waist Circumference in Centimeters
At end-of-intervention, participants' waist circumference was assessed in centimeters.
Measured: end-of-intervention, at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start28 Aug 2023
- Primary completion31 Oct 2024
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jessica Krok-Schoen, Ohio State University Comprehensive Cancer Center
- Investigators
- Jessica L Krok-Schoen, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016725
- Sponsor's protocol ID
- OSU-22329
- Other IDs
- NCI-2023-04622, R21AG078258
- Acronym
- E-PROOF
- Status last verified
- Nov 2025
- First submitted
- 26 Jun 2023
- Last updated
- 2 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-PROOF: E-Intervention for Protein Intake and Resistance Training to Optimize Function
- ClinicalTrials.gov ID
- NCT06016725
- Acronym / sponsor ID
- E-PROOF / OSU-22329
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Posted 2 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Experimental | Other: Exercise Intervention, Other: Informational Intervention, Other: Nutritional Assessment, Other: Physical Performance Testing, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (educational materials) | Active comparator | Other: Informational Intervention, Other: Physical Performance Testing, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive educational materials at baseline. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- >= 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionParticipate in online resistance training sessions | Other | Arm 1 (nutritional counseling, resistance training) |
| Informational InterventionGiven educational materials | Other | Arm 1 (nutritional counseling, resistance training), Arm 2 (educational materials) |
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingParticipate in online nutritional counseling | Other | Arm 1 (nutritional counseling, resistance training) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Arm 1 (nutritional counseling, resistance training), Arm 2 (educational materials) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm 1 (nutritional counseling, resistance training), Arm 2 (educational materials) |
| Questionnaire AdministrationAncillary studies | Other | Arm 1 (nutritional counseling, resistance training), Arm 2 (educational materials) |
Primary outcome
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.
13 secondary outcomes
Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions
Time frame: end-of-intervention, at 12 weeks
Study Accrual Rate
Time frame: assessed during the 12 month recruitment period
Study Retention Rate
Time frame: End-of-study, up to 3 months
Study Adherence Rate
Time frame: end-of-intervention, at 12 weeks
Grip Strength
Time frame: end-of-intervention, at 12 weeks
Dietary Quality
Time frame: end-of-intervention, at 12 weeks
Percentage of Participants Who Completed Resistance Exercises
Time frame: end-of-intervention, at 12 weeks
Health-related Quality of Life (HRQoL)
Time frame: end-of-intervention, at 12 weeks
Self-efficacy
Time frame: end-of-intervention, at 12 weeks
Technology Competency
Time frame: end-of-intervention, at 12 weeks
Anthropometry Body Weight in Kilograms
Time frame: end-of-intervention, at 12 weeks
Anthropometry Height in Inches
Time frame: end-of-intervention, at 12 weeks
Anthropometry Measuring Waist Circumference in Centimeters
Time frame: end-of-intervention, at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica L Krok-Schoen, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Informational Intervention and Nutritional Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function at End-of-intervention (time frame: end-of-intervention, at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.