Breast CancerNCT00583726
The Women's Healthy Lifestyle Study
A study testing motivational interviewing and written materials only in people with Breast Cancer, run by University of Michigan at 1 site in United States.
Trial summary
This study aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- motivational interviewing and written materials only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Nov 2011
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female, age 18 and older
- Stage I, II, or IIIA breast cancer
- Scheduled for chemotherapy and completed no more than two weeks of chemotherapy
- Body mass index 25-45 kg/m2
- Stable body weight within 5 pounds in the past 2 months
- Physician approval for participating in a weight control program
- Willing and able to follow advice for exercise and diet quality
Who cannot join
- Previous invasive cancers, excluding basal cell carcinoma, in the past 10 years
- Following a medically-prescribed diet
- Currently participating in a formal weight loss program
- Medical conditions that preclude safe exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivational Interviewing for Weight Maintenance
This study aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond.
Read the detailed description
Women receiving chemotherapy for early stage breast cancer often gain weight and body fat, and this contributes to the health burden that cancer survivors face. Weight gain is a concern not only for overall health status, but also as a possible factor for risk of cancer recurrence. Unfortunately achieving weight loss, after a gain has occurred, is difficult, and there are no satisfactory methods for maintenance of weight loss. This study proposes to design and test a novel telephone-based intervention for preventing weight gain during treatment for breast cancer in a pilot, randomized study. The 12-month intervention will target maintenance of current weight and prevention of body fat gain using counseling for moderate exercise and a low-fat, high fruit-vegetable diet. The counseling approach will be based on motivational interviewing techniques and will be delivered through telephone appointments. Motivational interviewing is a client-centered type of counseling that elicits active participation of the patient. By taking a more active role, patients may be more likely to follow through with the recommended lifestyle changes. Study endpoints will include blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires (including quality of life) and anthropometric measures (including body fat by DEXA). An important goal of the study is to establish recruitment methods and demonstrate recruitment rates in newly diagnosed stage I-IIIA breast cancer patients. The study data also will demonstrate implementation of the counseling approach and provide a basis for sample size estimates for a larger trial. This type of intervention, namely a combination of exercise and diet, has been indicated to have good potential for prevention of recurrence. It is therefore necessary to develop effective methods for eliciting these behaviors.
- Conditions
- Breast Cancer
- Being tested
- motivational interviewing, written materials only
- Keywords
- chemotherapy, exercise, diet, fruit, vegetables, low-fat
- 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.
motivational interviewingBehavioural
telephone counseling
written materials onlyBehavioural
dietary guidance materials and pedometers
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The control arm receives written information and pedometers Receives: Behavioral: written materials only |
| 2 | Experimental | This arm also receives telephone counseling. Receives: Behavioral: motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: 12 months
Secondary outcomes (1)
Change in body fat
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zora Djuric, University of Michigan
- Investigators
- Zora Djuric, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583726
- Sponsor's protocol ID
- HUM00012524
- Status last verified
- Dec 2012
- First submitted
- 20 Dec 2007
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Djuric Z, Ellsworth JS, Weldon AL, Ren J, Richardson CR, Resnicow K, Newman LA, Hayes DF, Sen A. A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. Open Obes J. 2011;3:87-97. doi: 10.2174/1876823701103010087.
PubMed 22238561Djuric Z, Ren J, Brown PR, Ellsworth JS, Sen A. Lifestyle factors associated with serum N-3 fatty acid levels in breast cancer patients. Breast. 2012 Aug;21(4):608-11. doi: 10.1016/j.breast.2012.02.003. Epub 2012 Feb 28.
PubMed 22377591
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing for Weight Maintenance
- ClinicalTrials.gov ID
- NCT00583726
- Acronym / sponsor ID
- HUM00012524
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, exercise, diet, fruit, vegetables, low-fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Dec 2007 (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 aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond.
Detailed description
Women receiving chemotherapy for early stage breast cancer often gain weight and body fat, and this contributes to the health burden that cancer survivors face. Weight gain is a concern not only for overall health status, but also as a possible factor for risk of cancer recurrence. Unfortunately achieving weight loss, after a gain has occurred, is difficult, and there are no satisfactory methods for maintenance of weight loss. This study proposes to design and test a novel telephone-based intervention for preventing weight gain during treatment for breast cancer in a pilot, randomized study. The 12-month intervention will target maintenance of current weight and prevention of body fat gain using counseling for moderate exercise and a low-fat, high fruit-vegetable diet. The counseling approach will be based on motivational interviewing techniques and will be delivered through telephone appointments. Motivational interviewing is a client-centered type of counseling that elicits active participation of the patient. By taking a more active role, patients may be more likely to follow through with the recommended lifestyle changes. Study endpoints will include blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires (including quality of life) and anthropometric measures (including body fat by DEXA). An important goal of the study is to establish recruitment methods and demonstrate recruitment rates in newly diagnosed stage I-IIIA breast cancer patients. The study data also will demonstrate implementation of the counseling approach and provide a basis for sample size estimates for a larger trial. This type of intervention, namely a combination of exercise and diet, has been indicated to have good potential for prevention of recurrence. It is therefore necessary to develop effective methods for eliciting these behaviors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: written materials onlyThe control arm receives written information and pedometers |
| 2 | Experimental | Behavioral: motivational interviewingThis arm also receives telephone counseling. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult female, age 18 and older
- Stage I, II, or IIIA breast cancer
- Scheduled for chemotherapy and completed no more than two weeks of chemotherapy
- Body mass index 25-45 kg/m2
- Stable body weight within 5 pounds in the past 2 months
Key exclusion criteria (4 listed)
- Previous invasive cancers, excluding basal cell carcinoma, in the past 10 years
- Following a medically-prescribed diet
- Currently participating in a formal weight loss program
- Medical conditions that preclude safe exercise
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 |
|---|---|---|
| motivational interviewingtelephone counseling | Behavioural | 2 |
| written materials onlydietary guidance materials and pedometers | Behavioural | 1 |
Primary outcome
Change in body weight
Time frame: 12 months
1 secondary outcome
Change in body fat
Time frame: 12 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 2 Dec 2015.
- Results publication: PubMed 22238561Djuric Z, Ellsworth JS, Weldon AL, Ren J, Richardson CR, Resnicow K, Newman LA, Hayes DF, Sen A. A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. Open Obes J. 2011;3:87-97. doi: 10.2174/1876823701103010087.
- Results publication: PubMed 22377591Djuric Z, Ren J, Brown PR, Ellsworth JS, Sen A. Lifestyle factors associated with serum N-3 fatty acid levels in breast cancer patients. Breast. 2012 Aug;21(4):608-11. doi: 10.1016/j.breast.2012.02.003. Epub 2012 Feb 28.
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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.
Zora Djuric, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing and written materials only in people with Breast Cancer, run by University of Michigan 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 7 inclusion and 4 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 2 Dec 2015. 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 body weight (time frame: 12 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 NCT00583726, which also lists 2 linked publications.
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 2 Dec 2015.