Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors

April 1, 2024 updated by: Brian Focht, Ohio State University Comprehensive Cancer Center

Healthy New Albany: Breast Cancer Project

This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.

II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors.

III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors.

OUTLINE:

Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.

After completion of study, patients are followed up at 3 and 6 months.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
  • Overweight/obese (body mass index [BMI] > 25).
  • Ability to understand and the willingness to sign a written informed consent.
  • Willing and physically able to participate in physical activity.
  • Obtain physician consent via primary care physician and/or treating oncologist.

Exclusion Criteria:

  • > 60 months post breast cancer therapy.
  • Contraindications to exercise.
  • Diagnosis of cancer other than breast that is receiving active treatment.
  • Currently receiving chemotherapy/radiation.
  • Musculoskeletal/neurological disorder inhibiting them from safe exercise.
  • Pregnant or nursing women.
  • Unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (exercise program, counseling)
Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Aerobic Exercise
Undergo aerobic exercise
Other Names:
  • Aerobic Activity
Other: Exercise Counseling
Receive behavioral activity counseling
Other: Nutritional Assessment
Receive nutritional counseling
Other Names:
  • dietary counseling
  • Dietary Assessment
  • nutritional counseling
Other: Resistance Training
Undergo resistance exercises
Other Names:
  • Strength Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility disability
Time Frame: Baseline up to 6 months
Assessed with the 400-meter walk test. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the last observation carried forward (LOCF) approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Baseline up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported physical function
Time Frame: Baseline up to 6 months
Measure with the abbreviated Late-Life Function and Disability Inventory. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Baseline up to 6 months
Objective functional performance
Time Frame: Baseline up to 6 months
Using 3 valid and reliable timed performance-related mobility tasks: 400-meter walk (the primary outcome), stair-climb, and lift and carry task. Assessments of Mobility-Related Self-Efficacy to complete each functional task will also be completed with the tests. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Baseline up to 6 months
Balance deficits assessment
Time Frame: Baseline up to 6 months
Estimate standing and reaching balance using a balance plate. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Baseline up to 6 months
Muscular strength assessement
Time Frame: Baseline up to 6 months
Using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Baseline up to 6 months
Body composition
Time Frame: Baseline up to 6 months
Dual-energy x-ray absorptiometry (DEXA) for all outcome measures. The DEXA scans were used to determine total body composition including bone-mineral density, as well as, percentage body fat and fat-free mass for all body regions. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Baseline up to 6 months
Body weight
Time Frame: Baseline up to 6 months
Measured to the nearest 0.1 kilogram using a calibrated and certified balance beam scale. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Baseline up to 6 months
Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12)
Time Frame: Baseline up to 6 months
The SF-12 questionnaire is a 12 -item scale that assesses the Physical (PCS) and Mental Health (MCS) composite summary scales composed of 6 items each on a 5-point rating scale. PCS and MCS scores range from 0-30 with higher scores indicating more favorable outcomes.
Baseline up to 6 months
Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B).
Time Frame: Baseline up to 6 months
The Functional Assessment of Cancer Therapy-Breast is a disease specific measures including the satisfaction with life scale. The Functional Assessment of Cancer Therapy-breast will be used to analyze sample T-tests.
Baseline up to 6 months
Brief Fatigue Inventory (BFI)
Time Frame: Baseline up to 6 months
The Brief Fatigue Inventory is a 9-item scale scored on an 11-point rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores represent greater levels of fatigue. In this form, there are 5 overarching questions. The first one asks, "Have you felt unusually tired or fatigued in the last week?" which is simply a Yes or No response. The next 4 questions then have answers in terms of a scale. The next 3 have the following sliding scale: 0= No Fatigue, 10= As bad as you can imagine, with 1-9 each representing intermediate responses. For the last question, the scale is: 0= Does not interfere, 10= Completely interferes, with 1-9 representing individual intermediate responses.
Baseline up to 6 months
Adherence assessment
Time Frame: Up to 6 months
Will be defined via attendance at prescribed sessions and will be assessed using exercise logs, upon which participants will record all exercise performed at the center or independently. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Up to 6 months
Feasibility measures
Time Frame: Up to 24 weeks
Descriptive statistics for assessments of recruitment rates, adverse events, and retention rates will be calculated prospectively throughout the trial. Feasibility assessments of participants? satisfaction with the exercise and dietary intervention will also be completed at the end of the 24-week intervention. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Brian C Focht, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2019

Primary Completion (Actual)

July 27, 2021

Study Completion (Actual)

July 27, 2021

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-17122
  • NCI-2019-00570 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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