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Online Dietary and Resistance Training to Improve Physical Function in Older Cancer Survivors, E-PROOF Trial
NA trial testing Exercise Intervention in Anatomic Stage I Breast Cancer AJCC v8 in 75 participants. Completed in 5 June 2025.
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 75 |
| Start date | 28 August 2023 |
| Primary completion | 31 October 2024 |
| Estimated completion | 5 June 2025 |
| Sites | 1 location across United States |
Ohio State University Comprehensive Cancer Center
65 and older, any sex, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 9.2 | ± 2.2 |
| Arm 2 (educational materials) | 9.1 | ± 2.3 |
Percentage of participant satisfaction ("satisfied" and "very satisfied") measured by a 5-item Likert-scale questionnaire. Scores range from 1-5, with 5 being the highest score of satisfaction.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 5 | 1 – 5 |
| Arm 2 (educational materials) | 5 | 1 – 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| All potential participants | 23.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 30 | |
| Arm 2 (educational materials) | 33 |
Participants were determined to be adherent if they attend \>= 80% of the online intervention sessions. Overall adherence rates and associated 95% confidence intervals were reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 97 | |
| Arm 2 (educational materials) | 95 |
Handgrip strength (absolute value at the end of the intervention) was measured in both hands using a hydraulic grip strength dynamometer. This is measured in kgs.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 28.6 | ± 5.2 |
| Arm 2 (educational materials) | 28.3 | ± 4.8 |
Dietary quality was 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. Absolute value at end-of-intervention was assessed using the Healthy Eating Index score.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 69.3 | 63 – 76 |
| Arm 2 (educational materials) | 68.1 | 61 – 75 |
Self-reported resistance exercise (% yes) was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. If a participant denoted "yes" to the question: did During a typical 7-Day period (a week), did you participate in resistance exercise for more than 15 minutes during your free time? Percentages denote the percentage of the study subjects who participated in resistance training at end of intervention.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 97 | |
| Arm 2 (educational materials) | 65 |
RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. All scores range from 0-100, with 100 as the highest HRQoL. The main HRQoL subscale reported is the general health HRQoL subscale. Mean scores of general HRQoL for end-of-intervention are reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 53.8 | ± 18.9 |
| Arm 2 (educational materials) | 60.1 | ± 19.1 |
Self-efficacy was measured at the end of intervention via a 0-10 confidence scale rating the confidence of making exercise and diet changes in one's life, with 0 meaning not confident, 10 meaning very confident.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 9.47 | ± 2.1 |
| Arm 2 (educational materials) | 8.97 | ± 1.9 |
The 8-item eHealth Literacy Scale measured knowledge, comfort, and perceived skills of engaging in eHealth at end-of-intervention. A 5-point Likert scale was used, with possible scores ranging from 8 to 40. Higher scores indicate higher ehealth literacy.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 33.9 | 27 – 40 |
| Arm 2 (educational materials) | 33.2 | 26 – 40 |
At end-of-intervention, participant's body weight was assessed in kilograms.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | 28 | 26 – 32 |
| Arm 2 (educational materials) | 29 | 24 – 33 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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