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Invasive Breast CarcinomaNCT03679559

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

A study testing Best Practice, Exercise Intervention (home walking program and resistance training) and Exercise Intervention (home-based Zumba program and resistance training) in people with Invasive Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Invasive Breast Carcinoma
What is being tested?
Best Practice, Exercise Intervention (home walking program and resistance training) and Exercise Intervention (home-based Zumba program and resistance training)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteUnited States
Study dates
6 Oct 2017to 2 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVE:

  1. 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.

Being tested
Best Practice, Exercise Intervention (home walking program and resistance training), Exercise Intervention (home-based Zumba program and resistance training), Exercise Intervention (HIIT program and resistance training), Informational Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Continue usual physical activity

  • Exercise Intervention (home walking program and resistance training)Behavioural

    Complete home-based walking program and resistance training

  • Exercise Intervention (home-based Zumba program and resistance training)Behavioural

    Complete home-based Zumba program and resistance training

  • Exercise Intervention (HIIT program and resistance training)Behavioural

    Complete HIIT program and resistance training

  • Informational InterventionOther

    Watch video

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Monitoring DeviceDevice

    Also called Monitor

    Wear Fitbit

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03679559
Study groupRoleWhat they receive
Arm I (home-based walking program, resistance training)ExperimentalParticipants wear Fitbit, receive home-based DVD containing instructions to warm-up and cool-down, and brisk walk 30 minutes per day 5 days a week in order to achieve the 150 minutes per week of moderate intensity exercise. Participants also receive resistance training by watching the illustration video and completing 6 total blocks of 2-week per block exercise using the Thera-BandR exercise bands.
Receives: Behavioral: Exercise Intervention (home walking program and resistance training); Behavioral: Exercise Intervention (HIIT program and resistance training); Other: Informational Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (home-based Zumba program, resistance training)ExperimentalParticipants 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 receive resistance training as in Arm I.
Receives: Behavioral: Exercise Intervention (home-based Zumba program and resistance training); Other: Informational Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm III (HIIT, resistance training)ExperimentalParticipants wear Fitbit and attend supervised HIIT exercise sessions 3 days per week over 12 weeks. Participants receive resistance training as in Arm I.
Receives: Behavioral: Exercise Intervention (HIIT program and resistance training); Other: Informational Intervention; Device: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm IV (supervised moderate intensity walking program)Active comparatorParticipants 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.
Receives: Behavioral: Exercise Intervention (HIIT program and resistance training)
Arm V (usual physical activity)Active comparatorParticipants wear Fitbit and continue their usual physical activity over 12 weeks.
Receives: Other: Best Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 weeks

Secondary outcomes (1)

  1. 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.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2018
  2. Study start6 Oct 2017
  3. Primary completion2 Jun 2022
  4. Study completion2 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679559
Sponsor's protocol ID
I 32816
Other IDs
NCI-2018-00455, I 32816
Status last verified
Aug 2023
First submitted
18 Sep 2018
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Exercise Intervention (home walking program and resistance training) and Exercise Intervention (home-based Zumba program and resistance training) in people with Invasive Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of randomized patients who are still on study at the end of the 12 week intervention (time frame: At 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03679559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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