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Internet-Based Weight-Loss Program for Colorectal Cancer Survivors

Primary Purpose

Cancer Survivor, Colorectal Cancer, Weight Changes

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet weight loss intervention
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cancer Survivor focused on measuring 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

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rutgers Cancer Institute of New Jersey
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Arm I (12-week Internet-based weight-loss intervention): After a baseline evaluation, subjects will start a 12 week Internet-based weight-loss intervention.

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.

Outcomes

Primary Outcome Measures

Feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer survivors
Impact of an Internet-based intervention on weight loss

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
Potential moderators of weight loss

Full Information

First Posted
December 13, 2009
Last Updated
March 2, 2017
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01032590
Brief Title
Internet-Based Weight-Loss Program for Colorectal Cancer Survivors
Official Title
Internet Weight Loss Intervention for Individuals Diagnosed With Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Trial was only opened at RCINJ for analysis of data, no patient enrollment took place here.
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2, 2017 (Actual)
Study Completion Date
March 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: To evaluate the feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer (CRC) survivors. To obtain preliminary outcome data on the impact of an Internet-based intervention on weight loss, waist circumference, physical activity, diet, weight-control strategies, weight-loss intention, exercise and diet self-efficacy, and perceived weight-loss barriers among CRC survivors. To obtain preliminary data on potential moderators (sociodemographics, disease and treatment characteristics, prior Internet experience, depressive symptoms, dieting and weight-loss experiences, weight-loss expectations, and physical activity and dietary outcome expectancies) of weight loss among CRC survivors using an Internet-based weight-loss intervention. OUTLINE: Patients are stratified according to time since completion of cancer treatment (1 to 2 years vs 3 to 4 years vs 5 to 6 years vs 7 to 10 years). Patients are randomized to 1 of 2 intervention arms. Arm I (12-week Internet-based weight-loss intervention): Patients attend an in-person 60-minute session with a health educator. The health educator will review the patient's weight history, current eating habits, prior and current level of physical activity, reasons for wanting to lose weight, current weight, weight-loss goals, and barriers to weight loss. The health educator will provide basic weight-loss advice for the patient, according to established guidelines, and advice on diet modification to reduce caloric intake. The health educator will also recommend gradual increases in physical activity and help patients set a realistic target weight to achieve at the end of the 12-week intervention period. The health educator will introduce the intervention website to the patient and assist the patient in setting up a confidential, unique login username and password that will provide secure access to the study website. Patients are asked to provide an email address. After logging onto the website and viewing an introductory page, patients are prompted to specify their target weight for the end of the 12-week intervention and to provide a list of reasons for wanting to lose weight. Next, the website prompts patients to list specific strategies that they plan to use to achieve their desired weight loss. The health educator will guide the patient in entering an initial set of strategies and will provide the patient a list of examples of weight-loss strategies and encourage the patient to generate his/her own specific, personalized strategies. Patients will also be able to select and adapt strategies from the example list that they feel are appropriate for them. The health educator will ensure that the patient is comfortable using the website and will give the patient a one-page written summary of how to use the website and a phone number and an e-mail address that they can use to receive technical help with the website. Additionally, patients are advised to login to the website twice a week during the 12-week intervention period and are 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. Patients will also receive automated e-mails that prompt them to visit the website and that provide them with weight-loss tips and motivational messages. The website also provides additional resources, including a list of credible external websites with useful weight loss information and healthy recipes, a summary of weight-loss tips, tips for creating appropriate weight-loss strategies, and examples of weight-loss strategies. 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. Patients in both arms complete surveys at baseline and at 12 weeks to assess sociodemographics, disease and treatment characteristics, prior Internet experience, depressive symptoms, weight, dieting and weight-loss experiences, weight-loss expectations, and physical activity and dietary outcome expectancies. Patients in arm II also complete an additional follow-up survey at 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Colorectal Cancer, Weight Changes
Keywords
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Arm I (12-week Internet-based weight-loss intervention): After a baseline evaluation, subjects will start a 12 week Internet-based weight-loss intervention.
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet weight loss intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer survivors
Time Frame
5 years
Title
Impact of an Internet-based intervention on weight loss
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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
Title
Potential moderators of weight loss
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Coups, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

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Internet-Based Weight-Loss Program for Colorectal Cancer Survivors

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