Metastatic Breast CancerNCT02682836
Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
A study testing Walk with Ease in people with Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Walk with Ease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 1 Dec 2019
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 21 or older
- Metastatic breast cancer (MBC) diagnosis - Stage IV
- Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens
- Approval from the treating clinician to engage in moderate-intensity physical activity.
- Patient-assessed ability to walk and engage in moderate physical activity
Show all 9Show fewer
- Proficient in English.
- IRB approved signed written informed consent.
- Willing and able to do all study requirements.
Who cannot join
- One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention.
- No more than 3 prior chemotherapy regimens.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Cancer Hospital
Chapel Hill, North Carolina, 27519
About this study
Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Walk with Ease
- Keywords
- physical activity, chemotherapy, fatigue
- Medical subject headings
- Breast Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk with EaseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Walk with Ease physical activity intervention Receives: Behavioral: Walk with Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in fatigue scores
Evaluate change in PROMIS Fatigue scores from baseline to 3 months
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten A Nyrop, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682836
- Sponsor's protocol ID
- LCCC1537
- Status last verified
- Jan 2022
- First submitted
- 10 Feb 2016
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Shachar SS, Heiling H, Muss HB, Meghan D, Wagoner CW, Deal AM, Nyrop KA. Physical Activity Intervention in Patients with Metastatic Breast Cancer During Active Treatment: Quality of Life and Function. Oncologist. 2023 Jan 18;28(1):84-e70. doi: 10.1093/oncolo/oyac232.
PubMed 36398879
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
- ClinicalTrials.gov ID
- NCT02682836
- Acronym / sponsor ID
- LCCC1537
- Conditions
- Metastatic Breast Cancer
- Keywords
- physical activity, chemotherapy, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life is a major goal of care. There is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an MBC diagnosis. The primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30 patients. Findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (RCT) in a large sample of women with metastatic breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Behavioral: Walk with EaseWalk with Ease physical activity intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age 21 or older
- Metastatic breast cancer (MBC) diagnosis - Stage IV
- Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or biologic regimens
- Approval from the treating clinician to engage in moderate-intensity physical activity.
Key exclusion criteria (2 listed)
- One or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention.
- No more than 3 prior chemotherapy regimens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk with Ease | Behavioural | single arm |
Primary outcome
changes in fatigue scores
Time frame: at 3 months
Evaluate change in PROMIS Fatigue scores from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Derived from this study: PubMed 36398879Shachar SS, Heiling H, Muss HB, Meghan D, Wagoner CW, Deal AM, Nyrop KA. Physical Activity Intervention in Patients with Metastatic Breast Cancer During Active Treatment: Quality of Life and Function. Oncologist. 2023 Jan 18;28(1):84-e70. doi: 10.1093/oncolo/oyac232.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten A Nyrop, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk with Ease in people with Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 9 inclusion and 2 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 6 Jan 2022. 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?
changes in fatigue scores (time frame: at 3 months). 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 NCT02682836, which also lists 1 linked publication.
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 6 Jan 2022.