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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

— E-PROOF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016725
• Other study ID #: OSU-22329
• Secondary ID: NCI-2023-04622R2
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: May 15, 2025

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 15, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Neoplasms
• Colorectal Neoplasms
• Prostatic Neoplasms
• 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

Intervention

Other:
• Exercise Intervention
Participate in online resistance training sessions
• Informational Intervention
Given educational materials
• Nutritional Assessment
Participate in online nutritional counseling
• Physical Performance Testing
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function	Measured by the Short Physical Performance Battery (SPPB) score. Efficacy will be based on 12 weeks. The SPPB score is a continuous variable, collected as the total score ranging from 0-12. Group differences in SPPB scores over the time will be tested using repeated measures analysis of variance. Using the planned contrasts command, we will investigate the changes in SPPB scores within each group, and between the intervention and control groups at end-of-study. Descriptive statistics and frequency distributions will be used to characterize the sample. To examine the effect of the intervention on the changes in physical function, a linear mixed effect model will be adopted.	Up to 12 weeks post study completion
Secondary	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	At 12 weeks
Secondary	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.	Up to 9 months
Secondary	Study retention rate	Will be 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.	At baseline and 12 weeks
Secondary	Study adherence rate	Participants will be determined to be adherent if they attend >= 80% of the intervention sessions (in-person meetings with study staff and online intervention sessions). Overall adherence rates and associated 95% confidence intervals will be reported.	At baseline, 12 weeks, and 3-month follow-up
Secondary	Muscle strength	Handgrip strength will be measured in both hands using a hydraulic grip strength dynamometer. Change in participant outcome measures from baseline to end-of-study will be assessed in kilograms at the baseline and end of study visits.	At baseline, 12 weeks, and 3-month follow-up
Secondary	Dietary quality and protein intake	Protein intake and dietary quality will be 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. Change in participant outcome measures from baseline to end-of-study will be assessed using the Healthy Eating Index score.	At baseline and 12 weeks
Secondary	Resistance exercises	Self-reported resistance exercise will be assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation, reported in frequency of days per week and duration in minutes. Change in participant outcome measures from baseline to end-of-study will be assessed using the reported frequency of days per week and duration in minutes.	At baseline and 12 weeks
Secondary	Health-related quality of life (HRQoL) physical and emotional health scores	RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. Physical and mental component summaries are created. All scores range from 0-100, with 100 as the highest. Change in participant outcome measures from baseline to end-of-study will be assessed using the RAND-36 Health Status Measure score.	At baseline and 12 weeks
Secondary	Self-efficacy for improving diet quality and increasing resistance training	Self-efficacy will be measured via a 0-10 confidence scale rating the confidence of making exercise and diet changes, with 0 meaning not confident, 10 meaning very confident. Change in participant outcome measures from baseline to end-of-study will be assessed using the confidence scale rating.	At baseline and 12 weeks
Secondary	Technology competency	The 8-item eHealth Literacy Scale will measure knowledge, comfort, and perceived skills of engaging in eHealth at baseline and end-of-study. A 5-point Likert scale will be used. Change in participant outcome measures from baseline to end-of-study will be assessed using the 5-point Likert scale score.	At baseline and 12 weeks
Secondary	Anthropometry body weight in kilograms	Change in participant outcome measure body weight from baseline to end-of-study will be assessed using body weight in kilograms.	At baseline and 12 weeks
Secondary	Anthropometry height in inches	Change in participant outcome measure height from baseline to end-of-study will be assessed using height in inches.	At baseline and 12 weeks
Secondary	Anthropometry measuring waist circumference in centimeters	Change in participant outcome measure waist circumference from baseline to end-of-study will be assessed using waist circumference in centimeters.	At baseline and 12 weeks

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