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N/A Completed N=75 Randomized Supportive Care

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

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
Source: ClinicalTrials.gov NCT06016725 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Physical Function at End-of-intervention — 9.2; 9.1 score on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Physical Function at End-of-intervention
9.2; 9.1
SECONDARY
Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions
5; 5
SECONDARY
Study Accrual Rate
23.1
SECONDARY
Study Retention Rate
30; 33
SECONDARY
Study Adherence Rate
97; 95
SECONDARY
Grip Strength
28.6; 28.3
SECONDARY
Dietary Quality
69.3; 68.1
SECONDARY
Percentage of Participants Who Completed Resistance Exercises
97; 65
SECONDARY
Health-related Quality of Life (HRQoL)
53.8; 60.1
SECONDARY
Self-efficacy
9.47; 8.97
SECONDARY
Technology Competency
33.9; 33.2
SECONDARY
Anthropometry Body Weight in Kilograms
28; 29
SECONDARY
Anthropometry Height in Inches
165.2; 166.1
SECONDARY
Anthropometry Measuring Waist Circumference in Centimeters
100; 101

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06016725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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