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Healthy Living After Cancer: Weight Management Pilot Study

This study is not yet open for participant recruitment.
Verified December 2013 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Friends of the Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01978899
First received: October 9, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

Studies have shown that patients who weigh more at the time of cancer diagnosis may be at increased risk of complications from surgery, fatigue, poor body image and other problems. Some research suggests that losing weight after cancer diagnosis can lead to improvements in these problems, as well as having other potential benefits for cancer survivors. Programs that reduce calories and increase exercise have been shown to help cancer survivors lose weight, but more research is needed to develop and test weight loss programs in cancer survivors.

This study is designed to look at the ability of a 16-week diet and exercise program to help cancer survivors lose weight. The investigator will look at changes in weight, body composition, quality of life, fatigue, body image as well as diet and exercise patterns, to see if this program can help men and women feel better and live healthier lives after cancer diagnosis.


Condition Intervention
Weight Loss Program After Cancer Diagnosis
Behavioral: Immediate Weight Loss Program Group
Behavioral: Delayed Weight Loss Program Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Healthy Living After Cancer: Weight Management Pilot Study

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the impact of a 16-week, group-based weight loss intervention upon body weight in a group of cancer survivors. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Change in weight (post-pre)weight loss intervention


Secondary Outcome Measures:
  • To evaluate the impact of a 16-week weight loss intervention upon the following in a group of cancer survivors. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Correlate the effect of the intervention with anthropometric outcomes of percentage change or differences, changes in QOL, physical activity, or body image relative to baseline.


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate Weight Loss Program Group

Immediate Weight Loss Program Group

  • The weight loss Program Group will include weekly in-person sessions comprised of dietary counseling and increased physical activity. Patients will also be provided with exercise and dietary goals each week to implement at home.
  • Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks.
Behavioral: Immediate Weight Loss Program Group
Active Comparator: Delayed Weight Loss Program Group
The Delayed Weight Loss Program Group will take part in the weight loss intervention after the 16-week control period. Assessments will occur at baseline (pre-randomization), at the end of the 16-week intervention or control period and at 32 weeks
Behavioral: Delayed Weight Loss Program Group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to any study-related procedures
  • History of any malignancy
  • Completed with all adjuvant surgery, chemotherapy and/or radiation at least one month prior to study enrollment (patients receiving ongoing hormonal or biologic therapy are eligible to participate)
  • BMI >25kg/m2
  • ECOG performance status of 0 or 1
  • At least 18 years old
  • Physically able to exercise and physician consent to start a weight loss program
  • Willingness to be randomized
  • English speaking and able to read English

Exclusion Criteria:

  • Self-reported inability to walk 2 blocks (at any pace)
  • Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
  • Bariatric surgery within the last year
  • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
  • Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978899

Contacts
Contact: Jennifer Ligibel, MD jligibel@partners.org
Contact: Laura Shockro 617-632-5934 lshockro@partners.org

Locations
United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer Ligibel, MD    617-632-3428    jligibel@partners.org   
Principal Investigator: Jennifer Ligibel, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Friends of the Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jennifer Ligibel, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jennifer A. Ligibel, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01978899     History of Changes
Other Study ID Numbers: 13-336
Study First Received: October 9, 2013
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014