Breast Cancer SurvivorshipLEAN3NCT02681965
A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors
A study testing LEAN book/videos in people with Breast Cancer Survivorship and Obesity, run by Yale University at 1 site in United States.
Trial summary
Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list… Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Breast Cancer Survivorship, Obesity
- What is being tested?
- LEAN book/videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 1 Apr 2018
- 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 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight individuals (BMI >= 25.0 kg/m2)
- Breast cancer survivors who have completed chemotherapy and/or radiation therapy
- Stage 0-III
- The ability to be physically able to exercise (e.g. walk at a moderate pace)
- Agree to random assignment to either group
- Give informed consent to participate in all study activities
- Accessible by telephone
- Able read and communicate in English
Who cannot join
- Pregnant or intending to become pregnant in the next year
- Recent (past 6 months) stroke or myocardial infarction
- Severe uncontrolled mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.
Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).
Read the detailed description
The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.
The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.
Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.
- Conditions
- Breast Cancer Survivorship, Obesity
- Being tested
- LEAN book/videos
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAN book/videosBehavioural
The intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| LEAN | Experimental | Participants randomized to the weight loss program will initially receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity. Written instructions in the LEAN book will include recording daily diet and exercise in the logs. At the end of the study, participants will return, via a stamped addressed envelope, the logs to the study office so compliance can be assessed. Receives: Behavioral: LEAN book/videos |
| Waitlist Control | No intervention | Participants randomized to the waitlist control study arm will be mailed the six-month questionnaires, which will include reporting of weight. On return of the 6-month questionnaires each woman will be provided with the entire weight loss program packet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).
Measured: 6 Months
Secondary outcomes (13)
Body weight (kg)
A standard digital scale will be used to measure participants at baseline. Body weight will be collected in kilograms (kg).
Measured: Baseline
Body weight (kg)
A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).
Measured: 12 Months
Quality of Life (QOL)
QOL will be self-reported and collected at the baseline and 6-months. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire will be administered to assess overall quality of life. The FACT-B measures physical, emotional, social, and functional well-being as well as quality of life issues specific to breast cancer survivors. The overall score will be used for assessment.
Measured: Baseline
Quality of Life (QOL)
QOL will be self-reported and collected at the baseline and 6-months. The Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire will be administered to assess overall quality of life. The FACT-B measures physical, emotional, social, and functional well-being as well as quality of life issues specific to breast cancer survivors. The overall score will be used for assessment.
Measured: 6 months
Dietary Intake
The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women's Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake.
Measured: Baseline
Dietary Intake
The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women's Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake.
Measured: 6 months
Dietary Intake
The endpoint measures of diet change will be mean, group level changes in daily caloric intake, based on a 120-item food frequency questionnaire (FFQ) which was developed for the Women's Health Initiative Study and has been validated against 4-Day Food Records and 24-hour Dietary Recalls. The FFQ is used to generate the Healthy Eating Index score (HEI). The HEI will be used to assess dietary intake.
Measured: 12 months
Physical Activity (Moderate)
Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.
Measured: Baseline
Physical Activity (Moderate)
Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.
Measured: 6 months
Physical Activity (Moderate)
Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.
Measured: 12 months
Physical Activity (Vigorous)
Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.
Measured: Baseline
Physical Activity (Vigorous)
Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.
Measured: 6 months
Physical Activity (Vigorous)
Women will complete a physical activity questionnaire to assess their past six months of physical activity.10 Hours/week spent in different types (recreational, household, and occupation) and intensities (light, moderate, and vigorous-intensity) of activity will be computed over the past six months. Total minutes per week will be calculated from this survey for moderate and vigorous activity.
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 posted15 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by Yale 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yale School of Medicine Irwin, Ph.D., Principal investigator, MEPH Chronic Diseases, Yale School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681965
- Sponsor's protocol ID
- 1410014716
- Acronym
- LEAN3
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2016
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial, Using a Mail and Video-based Weight Loss Program for Overweight or Obese Stage I-IIIC Breast Cancer Survivors.
- ClinicalTrials.gov ID
- NCT02681965
- Acronym / sponsor ID
- LEAN3 / 1410014716
- Conditions
- Breast Cancer Survivorship, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (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.
Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).
Detailed description
The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.
The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.
Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEAN | Experimental | Behavioral: LEAN book/videosParticipants randomized to the weight loss program will initially receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity. Written instructions in the LEAN book will include recording daily diet and exercise in the logs. At the end of the study, participants will return, via a stamped addressed envelope, the logs to the study office so compliance can be assessed. |
| Waitlist Control | No intervention | –Participants randomized to the waitlist control study arm will be mailed the six-month questionnaires, which will include reporting of weight. On return of the 6-month questionnaires each woman will be provided with the entire weight loss program packet. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Overweight individuals (BMI >= 25.0 kg/m2)
- Breast cancer survivors who have completed chemotherapy and/or radiation therapy
- Stage 0-III
- The ability to be physically able to exercise (e.g. walk at a moderate pace)
- Agree to random assignment to either group
Key exclusion criteria (3 listed)
- Pregnant or intending to become pregnant in the next year
- Recent (past 6 months) stroke or myocardial infarction
- Severe uncontrolled mental illness
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 |
|---|---|---|
| LEAN book/videosThe intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity. | Behavioural | LEAN |
Primary outcome
Body weight (kg)
Time frame: 6 Months
A standard digital scale will be mailed to each participant along with the baseline packet to allow consistent measurement of weight by participants. Participants will weigh themselves. Body weight will be collected in kilograms (kg).
13 secondary outcomes
Body weight (kg)
Time frame: Baseline
Body weight (kg)
Time frame: 12 Months
Quality of Life (QOL)
Time frame: Baseline
Quality of Life (QOL)
Time frame: 6 months
Dietary Intake
Time frame: Baseline
Dietary Intake
Time frame: 6 months
Dietary Intake
Time frame: 12 months
Physical Activity (Moderate)
Time frame: Baseline
Physical Activity (Moderate)
Time frame: 6 months
Physical Activity (Moderate)
Time frame: 12 months
Physical Activity (Vigorous)
Time frame: Baseline
Physical Activity (Vigorous)
Time frame: 6 months
Physical Activity (Vigorous)
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 29 Jun 2018.
- 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.
Yale School of Medicine Irwin, Ph.D. principal investigator
MEPH Chronic Diseases, Yale School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEAN book/videos in people with Breast Cancer Survivorship and Obesity, run by Yale 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 8 inclusion and 3 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 29 Jun 2018. 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?
Body weight (kg) (time frame: 6 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 29 Jun 2018.