Breast CanceriWEBNCT01728506
An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors
A study testing Weight Loss and Exercise in people with Breast Cancer, run by University of Vermont at 3 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. Read more about this study
- Who is it for?
- Ages 21 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Weight Loss and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Jul 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 21 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- breast cancer diagnosis
- Completion of surgery, chemotherapy +/- radiation for stage I, II, or III breast cancer 2-12 months prior to study initiation
- BMI between 27 and 50
- patient self-report of ability to walk for 10 minutes without interruption or pain
- access to computer and the internet
Who cannot join
- metastatic disease
- prior receipt of chemotherapy for other malignancy
- pregnancy at the time of study entry
- limited food choices due to celiac sprue or inflammatory bowel disease
- illiteracy
- non-English speaking
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Unviersity of Vermont/Fletcher Allen Health Care
Burlington, Vermont, 05405
Dartmouth Hitchcock Medical Center
Hannover, New Hampshire, 03755
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program
The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people.
This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations.
Read more
Participants will be recruited from three New England Cancer Centers - the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires.
Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line "chats" about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study.
- Conditions
- Breast Cancer
- Being tested
- Weight Loss and Exercise
- Keywords
- breast cancer survivor, Weight loss, Exercise
- Medical subject headings
- Breast Neoplasms, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss and ExerciseBehavioural
Internet delivered, behaviorally based weight loss and exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss & Exercise | Experimental | Single arm intervention of a 24 week weight loss and exercise intervention. Receives: Behavioral: Weight Loss and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study.
Measured: Change from baseline fesability at 6 months
Change in diet measures
Efficacy will be measured using total calories and fat grams before and after the intervention
Measured: Change from baseline diet measures at 6 months
Change in anthropometric measures
Change in Weight, BMI, body fat percentage before and after the intervention
Measured: Change from baseline anthropometrics at 6 months
Change in active energy expenditure (ie exercise)
exercise will be measured using an accelerometer before and after the intervention
Measured: Change from baseline active energy expenditure at 6 months
Secondary outcomes (2)
Change in inflammatory biomarkers
Change in Il-6, hsCRP before and after the intervention
Measured: Change from baseline inflammatory biomarkers at 6 months
Change in insulin resistance markers
Change in Homeostatic model assessment to estimate beta cell function and insulin resistance before and after the intervention
Measured: Change from baseline insulin resistance markers at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
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.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Kim Dittus, University of Vermont
- Investigators
- Kim L Dittus, MD PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728506
- Sponsor's protocol ID
- VCC 1109
- Acronym
- iWEB
- Status last verified
- May 2015
- First submitted
- 24 Jul 2012
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program
- ClinicalTrials.gov ID
- NCT01728506
- Acronym / sponsor ID
- iWEB / VCC 1109
- Conditions
- Breast Cancer
- Keywords
- breast cancer survivor, Weight loss, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, University of Massachusetts, Worcester
- Study start
- Oct 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 19 Nov 2012 (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.
The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people.
This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations.
Participants will be recruited from three New England Cancer Centers - the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires.
Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line "chats" about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight Loss & Exercise | Experimental | Behavioral: Weight Loss and ExerciseSingle arm intervention of a 24 week weight loss and exercise intervention. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- breast cancer diagnosis
- Completion of surgery, chemotherapy +/- radiation for stage I, II, or III breast cancer 2-12 months prior to study initiation
- BMI between 27 and 50
- patient self-report of ability to walk for 10 minutes without interruption or pain
- access to computer and the internet
Key exclusion criteria (6 listed)
- metastatic disease
- prior receipt of chemotherapy for other malignancy
- pregnancy at the time of study entry
- limited food choices due to celiac sprue or inflammatory bowel disease
- illiteracy
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 |
|---|---|---|
| Weight Loss and ExerciseInternet delivered, behaviorally based weight loss and exercise intervention | Behavioural | Weight Loss & Exercise |
Primary outcome
Feasibility
Time frame: Change from baseline fesability at 6 months
Feasibility will be determined by length of time required to obtain approval at all three sites, Numbers approached vs. numbers who participate in the study.
Change in diet measures
Time frame: Change from baseline diet measures at 6 months
Efficacy will be measured using total calories and fat grams before and after the intervention
Change in anthropometric measures
Time frame: Change from baseline anthropometrics at 6 months
Change in Weight, BMI, body fat percentage before and after the intervention
Change in active energy expenditure (ie exercise)
Time frame: Change from baseline active energy expenditure at 6 months
exercise will be measured using an accelerometer before and after the intervention
2 secondary outcomes
Change in inflammatory biomarkers
Time frame: Change from baseline inflammatory biomarkers at 6 months
Change in insulin resistance markers
Time frame: Change from baseline insulin resistance markers at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
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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.
Kim L Dittus, MD PhD principal investigator
University of Vermont
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss and Exercise in people with Breast Cancer, run by University of Vermont at 3 sites 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 5 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: status not confirmed, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Feasibility (time frame: Change from baseline fesability at 6 months). The study lists 4 primary outcomes in all. 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 18 May 2015.