Clinical trial NCT01728506: An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors
Official title: An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors: The iWEB Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer survivor
Weight loss
Exercise
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
name: University of Massachusetts, Worcester
First posted: 2012-11-19
Enrollment: 48
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility
timeFrame: Change from baseline fesability at 6 months
measure: Change in diet measures
timeFrame: Change from baseline diet measures at 6 months
measure: Change in anthropometric measures
timeFrame: Change from baseline anthropometrics at 6 months
measure: Change in active energy expenditure (ie exercise)
timeFrame: Change from baseline active energy expenditure at 6 months
Secondary outcomes:
measure: Change in inflammatory biomarkers
timeFrame: Change from baseline inflammatory biomarkers at 6 months
measure: Change in insulin resistance markers
timeFrame: Change from baseline insulin resistance markers at 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Hannover
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Burlington
country: United States
facility: Unviersity of Vermont/Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: University of Vermont
name: Kim L Dittus, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: