Healthy Living After Cancer: Weight Management Pilot Study

NCT01978899 | Completed DMC

• 1 other identifier: 13-336
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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 15-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.

Conditions

Weight Loss Program After Cancer Diagnosis

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of a 15-week, group-based weight loss intervention upon body weight in a group of cancer survivors.

  Change in weight (post-pre)weight loss intervention

  2 Years

Secondary Outcomes (1)

• To evaluate the impact of a 15-week weight loss intervention upon the following in a group of cancer survivors.

  2 Years

Study Arms (2)

Immediate Weight Loss Program Group

ACTIVE COMPARATOR

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

Delayed Weight Loss Program Group

ACTIVE COMPARATOR

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

Interventions

Immediate Weight Loss Program Group BEHAVIORAL

Participation in 15-week Healthy Living Program.

Immediate Weight Loss Program Group

Delayed Weight Loss Program Group BEHAVIORAL

Participation in 15-week Healthy Living Program following 15-week wait period.

Delayed Weight Loss Program Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Brown JC, Giobbie-Hurder A, Yung RL, Mayer EL, Tolaney SM, Partridge AH, Ligibel JA. The effects of a clinic-based weight loss program on health-related quality of life and weight maintenance in cancer survivors: A randomized controlled trial. Psychooncology. 2022 Feb;31(2):326-333. doi: 10.1002/pon.5817. Epub 2021 Sep 12.

  PMID: 34510643 DERIVED

Study Officials

• Jennifer Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)