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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2025-06-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Intervention Type OTHER

Ancillary studies

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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)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No