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Trial Title:
Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial
NCT ID:
NCT06016725
Condition:
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
Conditions: Official terms:
Breast Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Participate in online resistance training sessions
Arm group label:
Arm 1 (nutritional counseling, resistance training)
Intervention type:
Other
Intervention name:
Informational Intervention
Description:
Given educational materials
Arm group label:
Arm 1 (nutritional counseling, resistance training)
Arm group label:
Arm 2 (educational materials)
Intervention type:
Other
Intervention name:
Nutritional Assessment
Description:
Participate in online nutritional counseling
Arm group label:
Arm 1 (nutritional counseling, resistance training)
Other name:
Dietary Assessment
Other name:
dietary counseling
Other name:
nutritional counseling
Intervention type:
Other
Intervention name:
Physical Performance Testing
Description:
Ancillary studies
Arm group label:
Arm 1 (nutritional counseling, resistance training)
Arm group label:
Arm 2 (educational materials)
Other name:
Physical Fitness Testing
Other name:
Physical Function Testing
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm 1 (nutritional counseling, resistance training)
Arm group label:
Arm 2 (educational materials)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm 1 (nutritional counseling, resistance training)
Arm group label:
Arm 2 (educational materials)
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.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Start date:
August 28, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06016725
http://cancer.osu.edu
