Clinical trial NCT03751449: Exercise and Nutrition Education in Improving Physical Function and Quality of Life in Older Breast Cancer Survivors
Official title: Exercise and Nutrition Intervention in Older Breast Cancer Survivors - The WIN CA Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
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
Inactivity
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: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well exercise and nutrition education work in improving physical function and quality of life in older breast cancer survivors. Exercise and nutrition education may help to improve the level of fitness, cardiovascular health, and quality of life in breast cancer survivors.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention in overweight or obese, sedentary, older (65 years and above) breast cancer survivors on physical function (6-minute walk test) and quality of life compared to standard of care.

SECONDARY OBJECTIVES:

I. To assess the effect of a home-based aerobic and resistance exercise and nutrition education intervention on diet quality, sleep, anxiety, depression, source of motivation for exercise, and immune function in overweight or obese, sedentary, older (65 years and above) breast cancer survivors compared to standard of care.

EXPLORATORY OBJECTIVES:

I. To determine how body composition (dual X-ray absorptiometry \[DEXA\]) and weight maintenance are affected by a 12-week aerobic and resistance exercise training program among older (65 years and above), sedentary, overweight and obese breast cancer survivors.

II. To compare differences in the above outcomes among older (65 years and above), sedentary, overweight and obese breast cancer survivors who completed a home-based aerobic and resistance exercise training program versus those who did not receive the intervention, standard of care.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (ACTIVE TREATMENT): Participants complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.

GROUP II (WAITLIST): Participants are placed on a waitlist for 12 weeks and then complete a home-based aerobic and resistance exercise program and receive nutrition education for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Men or women with a history of breast cancer who have completed treatment \>=3 months ago (not including hormonal therapy, Zometa, or other non-chemotherapy/radiation cancer treatment at the discretion of the principal investigator)
* Physically inactive, defined as not meeting 150 minutes or 2 hours and 30 minutes a week of vigorous-intensity exercise
* Overweight or obese, defined as having a body mass index (BMI) between 26 kg/m\^2 and 42 kg/m\^2, inclusive
* Meeting criteria for participation in low to moderate risk exercise based on the American College of Sports and Medicine (ACSM) guideline
* Providing informed consent indicating understanding the investigational nature of this study by signing an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedures

Exclusion Criteria:

* Metastatic breast cancer
* Orthopedic or neuromuscular disorders that preclude participation in exercise
* Any history of myocardial infarction (MI), angina pectoris, or congestive heart failure
* High risk for moderate exercise based on ACSM risk classification
* Pregnant or nursing
* Unwilling or unable to follow protocol requirements
* Any condition which - in the investigator?s opinion - deems the participant an unsuitable candidate to participate in this study

Primary outcomes:
measure: Activity levels for all participants will be collected using the Fitbit applications and a weekly activity log.
timeFrame: Up to 2 years
measure: Quality of life as assessed by the Self Geriatric Assessment Measure (GA-Self Assessment)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Diet quality as assessed by the ASA24 website
timeFrame: Up to 2 years
measure: Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 2 years
measure: Anxiety and the effect of a home-based aerobic and resistance exercise and nutrition education intervention
timeFrame: Up to 2 years
measure: motivation for exercise as assessed by the Behavioral Regulation for Exercise Questionnaire (BREQ-2)
timeFrame: Up to 2 years
measure: Centers for Epidemiologic Studies Depression Scale (CESD-R)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Tracey O'Connor
role: PRINCIPAL_INVESTIGATOR
References: