Clinical trial NCT04454086: Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors
Official title: Healthy New Albany: Breast Cancer Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Cancer Survivor
Obesity
Overweight
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 21
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mobility disability
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Self-reported physical function
timeFrame: Baseline up to 6 months
measure: Objective functional performance
timeFrame: Baseline up to 6 months
measure: Balance deficits assessment
timeFrame: Baseline up to 6 months
measure: Muscular strength assessement
timeFrame: Baseline up to 6 months
measure: Body composition
timeFrame: Baseline up to 6 months
measure: Body weight
timeFrame: Baseline up to 6 months
measure: Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12)
timeFrame: Baseline up to 6 months
measure: Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B).
timeFrame: Baseline up to 6 months
measure: Brief Fatigue Inventory (BFI)
timeFrame: Baseline up to 6 months
measure: Adherence assessment
timeFrame: Up to 6 months
measure: Feasibility measures
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brian C Focht, PhD
role: PRINCIPAL_INVESTIGATOR
References: