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Internet-Based Weight-Loss Program for Colorectal Cancer Survivors

This study is not yet open for participant recruitment.
Verified June 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01032590
First received: December 13, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

RATIONALE: A personalized Internet-based weight-loss program may help improve the quality of life for colorectal cancer survivors.

PURPOSE: This randomized phase I trial is studying how well an Internet-based program works in helping colorectal cancer survivors lose weight.


Condition Intervention
Cancer Survivor
Colorectal Cancer
Weight Changes
 Behavioral: Internet weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Internet Weight Loss Intervention for Individuals Diagnosed With Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer survivors [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Impact of an Internet-based intervention on weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of an Internet-based intervention on waist circumference, physical activity, diet, weight-control strategies, weight-loss intention, exercise and diet self-efficacy, and perceived weight-loss barriers [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Potential moderators of weight loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Arm I (12-week Internet-based weight-loss intervention): After a baseline evaluation, subjects will start a 12 week Internet-based weight-loss intervention.
 Behavioral: Internet weight loss intervention
Participants will be advised to login to the website twice a week during the intervention period. They will be prompted to report their weight, to review and update their reasons for weight loss, to indicate their success with implementing each of their weight loss strategies, to rate the perceived effectiveness of each weight loss strategy,and to revise or create new strategies, as needed.
Active Comparator: Arm II
Arm II (wait-list control): Patients are instructed to continue their usual dietary and physical activity routines during a 12-week wait period. After the waiting period, patients receive the Internet-based weight-loss intervention for 12 weeks as in arm I.
 Behavioral: Internet weight loss intervention
Participants will be advised to login to the website twice a week during the intervention period. They will be prompted to report their weight, to review and update their reasons for weight loss, to indicate their success with implementing each of their weight loss strategies, to rate the perceived effectiveness of each weight loss strategy,and to revise or create new strategies, as needed.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colorectal cancer (CRC)

    • Stage I-III disease
  • Completed treatment for CRC 1-10 years ago
  • No current evidence of cancer

PATIENT CHARACTERISTICS:

  • Not nursing
  • Not pregnant within the past 6 months and not planning to become pregnant
  • Speaks English
  • Has access to the Internet at home or work
  • Lives within 50 miles of Fox Chase Cancer Center (FCCC)
  • Body mass index 25 to 35 kg/m^2
  • No weight loss of ≥ 15 lbs within the past 6 months
  • No history of eating disorder

  • None of the following medical conditions:

    • Myocardial infarction or stroke within the past 6 months
    • Type I diabetes
    • Uncontrolled hypertension
    • Unstable angina
    • Congestive heart failure

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent weight-loss medications (intervention phase)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032590

Locations
United States, New Jersey
Cancer Institute of New Jersey - Robert Wood Johnson Medical School Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Clinical Trials Office     732-235-8675        
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elliot Coups, PhD Cancer Institute of New Jersey
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01032590     History of Changes
Other Study ID Numbers: 130902, P30CA072720, CDR0000660594
Study First Received: December 13, 2009
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
weight changes
cancer survivor
stage I colon cancer
stage II colon cancer
 stage III colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Body Weight Changes
Colorectal Neoplasms
Weight Loss
Body Weight
Signs and Symptoms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 22, 2013