Exercise in Improving Health and Quality of Life in Breast Cancer Survivors

Invasive Breast Carcinoma Clinical Trial

Official title:

Exercise to Improve Health and Quality-of-Life in Breast Cancer Survivors: A Feasibility Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679559
• Other study ID #: I 32816
• Secondary ID: NCI-2018-00455I
• Status: Completed
• Phase: N/A
• Start date: October 6, 2017
• Est. completion date: June 2, 2022

Study information

• Verified date: August 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Carcinoma

Intervention

Other:
• Best Practice
Continue usual physical activity

Behavioral:
• Exercise Intervention (home walking program and resistance training)
Complete home-based walking program and resistance training
• Exercise Intervention (home-based Zumba program and resistance training)
Complete home-based Zumba program and resistance training
• Exercise Intervention (HIIT program and resistance training)
Complete HIIT program and resistance training

Other:
• Informational Intervention
Watch video
• Laboratory Biomarker Analysis
Correlative studies

Device:
• Monitoring Device
Wear Fitbit

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular fitness	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Other	Body composition	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Other	Quality of life	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. Will be assessed by the Functional Assessment of Cancer Therapy, Breast (FACTB+4).	At baseline and 12 weeks
Other	Cognitive function	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Other	Stress and immune function biomarkers	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Other	Mitochondrial function	Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program.	At baseline and 12 weeks
Primary	Proportion of randomized patients who are still on study at the end of the 12 week intervention	The feasibility outcomes will be assessed by a multivariable logistic regression model for the relative odds of remaining on the study (ref: not). Each of the active treatment arms will be compared to the control. The model will be supported by the randomized patient set, counting patients who withdraw from the study as feasibility failures. No variable selection steps will be taken; inferences will be based on the estimates and 95% confidence intervals from the full model. Optimism adjusted odds ratio estimates will also be reported, to better inform design of future studies.	At 12 weeks
Secondary	Adherence rate in each of the active intervention arms	Will be defined as the proportion of patients on study after 12 weeks who complete = 80% of the intervention activities. One-sided 90% Jeffrey's confidence limits will define a plausible lower limit on the range of values for true (unobserved) feasibility rate for each arm.	Up to 12 weeks