Clinical trial NCT03679559: Exercise in Improving Health and Quality of Life in Breast Cancer Survivors
Official title: Exercise to Improve Health and Quality-of-Life in Breast Cancer Survivors: A Feasibility Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Breast Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot trial studies how well exercise works in improving health and quality of life in breast cancer survivors. Participating in an exercise program to maintain physical activity may help to improve health and quality of life in breast cancer survivors.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the feasibility of conducting a 12-week preference option randomized exercise intervention program in breast cancer survivors.

SECONDARY OBJECTIVE:

I. To assess the adherence rate of each of the four 12-week intervention programs by breast cancer survivors in a randomized treatment arm and a patient preference arm.

OUTLINE: Participants are randomized into 1 of 5 arms.

ARM I: Participants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and walk 10000 steps per day over 12 weeks in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also undergo resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands.

ARM II: Participants wear Fitbit and receive a XBOX system and the video game to strive for at least 3 50-minute medium or high intensity classes per week over 12 weeks. Participants may also take 20-minute classes or a mixture of 50- and 20-minute classes to meet the target. Participants undergo resistance training as in Arm I.

ARM III: Participants wear Fitbit and attend supervised High Intensity Interval Training (HIIT) exercise sessions 3 days per week over 12 weeks. Participants undergo resistance training as in Arm I.

ARM IV: Participants wear Fitbit and attend supervised moderate intensity walking sessions weekly for 50-60 each over 12 weeks. Participants undergo resistance training as in Arm I.

ARM V: Participants wear Fitbit and continue their usual physical activity over 12 weeks.

After completion of study intervention, participants are followed up at 2 weeks and 1 month.

Eligibility criteria: Inclusion Criteria:

* Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Have a previous history of invasive breast cancer who have completed treatment except for hormonal therapy and zoledronic acid (Zometa)
* Do not meet the United States (U.S.) Center for Disease Control and Prevention's physical activity guidelines (150 minutes or 2 hours and 30 minutes a week of moderate-intensity exercise)
* Meets criteria for participation in low to moderate risk exercise based on the American College of Sports Medicine guideline (ACSM)

Exclusion Criteria:

* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Are pregnant or nursing
* Are unwilling or unable to follow protocol requirements
* Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
* Have metastatic breast cancer
* Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise

Primary outcomes:
measure: Proportion of randomized patients who are still on study at the end of the 12 week intervention
timeFrame: At 12 weeks
Secondary outcomes:
measure: Adherence rate in each of the active intervention arms
timeFrame: Up to 12 weeks
Other outcomes:
measure: Cardiovascular fitness
timeFrame: At baseline and 12 weeks
measure: Body composition
timeFrame: At baseline and 12 weeks
measure: Quality of life
timeFrame: At baseline and 12 weeks
measure: Cognitive function
timeFrame: At baseline and 12 weeks
measure: Stress and immune function biomarkers
timeFrame: At baseline and 12 weeks
measure: Mitochondrial function
timeFrame: At baseline and 12 weeks
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Ellis Levine
role: PRINCIPAL_INVESTIGATOR
References: