NCT04454086

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2021

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

July 16, 2019

Last Update Submit

April 1, 2024

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Cancer SurvivorObesityOverweightPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Mobility disability

    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 Outcomes (11)

  • Self-reported physical function

    Baseline up to 6 months

  • Objective functional performance

    Baseline up to 6 months

  • Balance deficits assessment

    Baseline up to 6 months

  • Muscular strength assessement

    Baseline up to 6 months

  • Body composition

    Baseline up to 6 months

  • +6 more secondary outcomes

Study Arms (1)

Supportive care (exercise program, counseling)

EXPERIMENTAL

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: Aerobic ExerciseOther: Exercise CounselingOther: Nutritional AssessmentOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationOther: Resistance Training

Interventions

Aerobic ExerciseOTHER

Undergo aerobic exercise

Also known as: Aerobic Activity
Supportive care (exercise program, counseling)
Exercise CounselingOTHER

Receive behavioral activity counseling

Supportive care (exercise program, counseling)
Nutritional AssessmentOTHER

Receive nutritional counseling

Also known as: Dietary Assessment, dietary counseling, nutritional counseling
Supportive care (exercise program, counseling)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Supportive care (exercise program, counseling)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (exercise program, counseling)
Resistance TrainingOTHER

Undergo resistance exercises

Also known as: Strength Training
Supportive care (exercise program, counseling)

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \> 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

ObesityOverweight

Interventions

ExerciseNutrition AssessmentResistance Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Brian C Focht, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 1, 2020

Study Start

March 6, 2019

Primary Completion

July 27, 2021

Study Completion

July 27, 2021

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)