Clinical trial NCT06016725: Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial
Official title: E-PROOF: E-Intervention for Protein Intake and Resistance Training to Optimize Function
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Stage II Prostate Cancer AJCC V8
Stage III Colorectal Cancer AJCC V8
Stage III Prostate Cancer AJCC V8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-30
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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)

Primary outcomes:
measure: Physical function
timeFrame: Up to 12 weeks post study completion
Secondary outcomes:
measure: Satisfaction of the delivery method and information provided by nutrition and exercise counseling sessions
timeFrame: At 12 weeks
measure: Study accrual rate
timeFrame: Up to 9 months
measure: Study retention rate
timeFrame: At baseline and 12 weeks
measure: Study adherence rate
timeFrame: At baseline, 12 weeks, and 3-month follow-up
measure: Muscle strength
timeFrame: At baseline, 12 weeks, and 3-month follow-up
measure: Dietary quality and protein intake
timeFrame: At baseline and 12 weeks
measure: Resistance exercises
timeFrame: At baseline and 12 weeks
measure: Health-related quality of life (HRQoL) physical and emotional health scores
timeFrame: At baseline and 12 weeks
measure: Self-efficacy for improving diet quality and increasing resistance training
timeFrame: At baseline and 12 weeks
measure: Technology competency
timeFrame: At baseline and 12 weeks
measure: Anthropometry body weight in kilograms
timeFrame: At baseline and 12 weeks
measure: Anthropometry height in inches
timeFrame: At baseline and 12 weeks
measure: Anthropometry measuring waist circumference in centimeters
timeFrame: At baseline and 12 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Jessica L Krok-Schoen, PhD
role: PRINCIPAL_INVESTIGATOR
References: