Breast CancerNCT01849978
Enhancing Exercise in Breast Cancer Survivors
A study testing Newsletter about physical activity and breast cancer survivors, Changing your habits brochure and Tips for making exercise enjoyable and personally-valued in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
This study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Newsletter about physical activity and breast cancer survivors, Changing your habits brochure and Tips for making exercise enjoyable and personally-valued
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no health restrictions on performing moderate to strenuous physical activity
- must be 18 years or older and able to give legal consent
Who cannot join
- may not be participating in another research study regarding exercise
- restrictions on performing physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
This study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise.
- Conditions
- Breast Cancer
- Being tested
- Newsletter about physical activity and breast cancer survivors, Changing your habits brochure, Tips for making exercise enjoyable and personally-valued, Testimonials from breast cancer survivors
- Keywords
- breast cancer, survivor, exercise, physical activity, strenuous exercise, moderate exercise, enjoyable exercise, enjoy exercise, breast cancer survivor
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newsletter about physical activity and breast cancer survivorsBehavioural
Both groups will receive a newsletter that covers: 1) the recommendation to pursue at least 150 mins/week of moderate to strenuous intensity PA, 2) the benefits of PA specific to breast cancer survivors (e.g., reducing in death and breast cancer recurrence), and 3) their total minutes of moderate to strenuous intensity PA and how this compares to the recommendation.
Changing your habits brochureBehavioural
Both groups will receive the brochure titled "Changing Your Habits: Steps to Better Health", developed by the NIH, that describes, based a person's stage of change, the benefits of PA, how to overcome common barriers to PA, and if ready, how to plan for PA.
Tips for making exercise enjoyable and personally-valuedBehavioural
Participants will get a list of potentially enjoyable activities and a space to list other activities after they consider aspects that can make events fun/interesting.13 Aspects to consider include: location (indoors vs. outdoors, the latter which may appeal to some), hobbies that can involve PA (e.g., sports, dancing), whether the activity is made more enjoyable by having it performed by oneself or with others (e.g., team activities vs. individual activities); what valued outcomes may be achieved (e.g., sense of competence, pride, better health, body image), accompanying activities that are pleasant (e.g., listening to music), etc.
Testimonials from breast cancer survivorsBehavioural
Participants will get two to three testimonials of actual breast cancer survivors. These testimonials will include story-like details of what these survivors find enjoyable about exercising and what they have done to make exercise enjoyable.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Participants in this arm will receive the newsletter about their reported minutes of physical activity and the benefits of physical activity specific to breast cancer survivors, and the brochure "Changing your habits," developed by the NIH. Receives: Behavioral: Newsletter about physical activity and breast cancer survivors; Behavioral: Changing your habits brochure |
| Habit Formation Arm | Active comparator | Participants in this arm will receive all of the intervention materials. Receives: Behavioral: Newsletter about physical activity and breast cancer survivors; Behavioral: Changing your habits brochure; Behavioral: Tips for making exercise enjoyable and personally-valued; Behavioral: Testimonials from breast cancer survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in number of minutes of moderate to strenuous physical activity
participants will self-report minutes of physical activity at baseline, 1 month, and 3 months after receiving intervention materials.
Measured: baseline, 1 month and 3 months
Secondary outcomes (1)
changes in joy and satisfaction with physical activity
participants will self-report via questionnaire their joy and satisfaction with their average physical activity level.
Measured: baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849978
- Sponsor's protocol ID
- Pro00044422
- Status last verified
- Jan 2016
- First submitted
- 6 May 2013
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exercise in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01849978
- Acronym / sponsor ID
- Pro00044422
- Conditions
- Breast Cancer
- Keywords
- breast cancer, survivor, exercise, physical activity, strenuous exercise, moderate exercise, enjoyable exercise, enjoy exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 May 2013 (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.
This study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Behavioral: Newsletter about physical activity and breast cancer survivors, Behavioral: Changing your habits brochureParticipants in this arm will receive the newsletter about their reported minutes of physical activity and the benefits of physical activity specific to breast cancer survivors, and the brochure "Changing your habits," developed by the NIH. |
| Habit Formation Arm | Active comparator | Behavioral: Newsletter about physical activity and breast cancer survivors, Behavioral: Changing your habits brochure, Behavioral: Tips for making exercise enjoyable and personally-valued, Behavioral: Testimonials from breast cancer survivorsParticipants in this arm will receive all of the intervention materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- no health restrictions on performing moderate to strenuous physical activity
- must be 18 years or older and able to give legal consent
Key exclusion criteria (2 listed)
- may not be participating in another research study regarding exercise
- restrictions on performing physical activity
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 |
|---|---|---|
| Newsletter about physical activity and breast cancer survivorsBoth groups will receive a newsletter that covers: 1) the recommendation to pursue at least 150 mins/week of moderate to strenuous intensity PA, 2) the benefits of PA specific to breast cancer survivors (e.g., reducing in death and breast cancer recurrence), and 3) their total minutes of moderate to strenuous intensity PA and how this compares to the recommendation. | Behavioural | Control arm, Habit Formation Arm |
| Changing your habits brochureBoth groups will receive the brochure titled "Changing Your Habits: Steps to Better Health", developed by the NIH, that describes, based a person's stage of change, the benefits of PA, how to overcome common barriers to PA, and if ready, how to plan for PA. | Behavioural | Control arm, Habit Formation Arm |
| Tips for making exercise enjoyable and personally-valuedParticipants will get a list of potentially enjoyable activities and a space to list other activities after they consider aspects that can make events fun/interesting.13 Aspects to consider include: location (indoors vs. outdoors, the latter which may appeal to some), hobbies that can involve PA (e.g., sports, dancing), whether the activity is made more enjoyable by having it performed by oneself or with others (e.g., team activities vs. individual activities); what valued outcomes may be achieved (e.g., sense of competence, pride, better health, body image), accompanying activities that are pleasant (e.g., listening to music), etc. | Behavioural | Habit Formation Arm |
| Testimonials from breast cancer survivorsParticipants will get two to three testimonials of actual breast cancer survivors. These testimonials will include story-like details of what these survivors find enjoyable about exercising and what they have done to make exercise enjoyable. | Behavioural | Habit Formation Arm |
Primary outcome
change in number of minutes of moderate to strenuous physical activity
Time frame: baseline, 1 month and 3 months
participants will self-report minutes of physical activity at baseline, 1 month, and 3 months after receiving intervention materials.
1 secondary outcome
changes in joy and satisfaction with physical activity
Time frame: baseline, 1 month, and 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 14 Jan 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Isaac Lipkus, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newsletter about physical activity and breast cancer survivors, Changing your habits brochure and Tips for making exercise enjoyable and personally-valued in people with Breast Cancer, run by Duke University 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 2 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 14 Jan 2016. 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?
change in number of minutes of moderate to strenuous physical activity (time frame: baseline, 1 month and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2016.