POWER-remote Weight Loss Program in Early Stage Breast Cancer

NCT01871116 | Completed DMC

• 1 other identifier: J12128
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to assess the effectiveness of a weight loss program in women with early stage breast cancer whose body mass index (BMI) is in the overweight or obese range (\>25). Weight loss is beneficial in improving cardiovascular risk factors and overall health, but may also decrease the chance of breast cancer coming back. A weight loss counseling program was studied in a general population and was found to be effective to help reduce weight over a 2 year period. The main goal of this study is to determine if women with a recent diagnosis of early breast cancer will also lose weight with this program. To better understand the effect that weight loss has on women with breast cancer, we will compare the patterns in blood and breast tissue samples (tissue biopsies will be optional), and questionnaires evaluating different aspects of one's well-being, before and after a dietary intervention or no intervention.

Conditions

Early Stage Breast Cancer

Keywords

breast cancer; early stage; weight loss

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  To compare the proportion of women with early stage breast cancer, who have completed all local therapy and adjuvant chemotherapy, who lose ≥5% of their baseline body weight after 6 and 12 months between a control arm (self-directed weight loss) and an experimental arm (POWER-remote)

  After 12 months

Secondary Outcomes (2)

• Change in biomarkers

  After 12 months

• Change in PROs (Patient Reported Outcomes)

  After 12 months

Study Arms (2)

POWER-remote

EXPERIMENTAL

Participants will start a weight loss program called POWER-remote for Breast Cancer Survivors. This program involves two main components: an online portion accessed on a computer through the internet and a telephone portion to help monitor progress.

Behavioral: POWER-remote

Self-directed

ACTIVE COMPARATOR

Participants will receive a pamphlet entitled "Aim for a Healthy Weight", to help guide weight loss goals without access to the web-based POWER-remote system and coach support.

Behavioral: Self-directed

Interventions

POWER-remote BEHAVIORAL

Web-based weight loss program.

POWER-remote

Self-directed BEHAVIORAL

Pamphlet entitled "Aim for a Healthy Weight" will be given.

Self-directed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• years or older
• Ductal carcinoma in situ (DCIS) or stage I-III invasive breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs, and willing to lose \>5% of their body weight. NOTE: Participants may not have documented weight loss greater than 5% of body weight from time of diagnosis. Exceptions that are felt to be due to surgical or other procedures (e.g., mastectomies or reconstruction) may be allowed with prior approval of the Protocol Chair/designee.
• Patients must have completed local therapy (i.e. surgery and radiation therapy), and any preoperative or adjuvant chemotherapy within \>3 and \<60 months of registration. NOTE: Concurrent anti-HER2 therapy is permitted. Concurrent endocrine breast cancer therapy is permitted; patients may enroll \>3 months after initiation of hormone therapy if expected to continue the same hormone agent for at least the first 6 months of the study. Concurrent enrollment in other interventional or drug clinical trials is at the discretion of the Protocol Chair.
• Willingness to change diet, physical activity and weight.
• To ensure compliance with the POWER-remote and PatientViewpoint programs, patients must meet the following: prior experience with web forms and feels able to use the POWER-remote web program and PatientViewpoint; has or is able to download Internet Explorer 8+, Firefox 3.0+, Safari 4.0+, Chrome 4.0+, and Adobe Flash Player 10; familiarity with and access to internet at least 4 days per week; use of an email program or willing and able to establish one for this study; and, able to read and write the English language without assistance.
• Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

You may not qualify if:

• History of another prior cancer within the last 5 years, with the exception of another breast cancer, adequately treated cone-biopsied in situ carcinoma of the cervix uteri, and basal or squamous cell carcinoma of the skin
• Medical condition likely to hinder accurate measurement of weight, including any condition: for which weight loss is contraindicated, which would likely cause weight loss, or which would affect adipokine and inflammatory markers (e.g., end stage renal disease (ESRD) on dialysis, cirrhosis, autoimmune disease, adrenal disease, and history of bariatric surgery).
• The use of the following medications are excluded: insulin or sulfonylureas; patients with thyroid disease who are not on stable doses of thyroid medication for at least the past 6 months; medications that cause weight loss (e.g., topiramate, bupropion, exenatide, lorcaserin, phentermine or orlistat) within the past 3 months; medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months; medications that may affect adipokine or inflammatory markers (e.g., sulfonylureas, glitazones, insulin, steroids, ACE inhibitors, beta blockers and statins) unless started ≥3 months prior to enrollment, or chronic NSAIDS (defined as use of ≥3 times a week) for ≥1 month.
• Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
• Currently enrolled or planning to enroll in a weight loss program (e.g., Innergy, Weight Watchers, Jenny Craig, Nutrisystem, and Medifast).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-0013, United States

Location

Related Publications (1)

• Sheng JY, Chen R, Rosner GL, Snyder CF, Appel LJ, Stearns V, Smith MT, Coughlin JW. The Impact of Baseline Sleep as a Potential Moderator of Weight Loss Intervention in Breast Cancer Survivors: Results From the POWER-Remote Trial. Obesity (Silver Spring). 2025 Dec 15. doi: 10.1002/oby.70096. Online ahead of print.

  PMID: 41397701 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vered Stearns, M.D.

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Weight loss intervention versus self-directed weight loss.

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)