Overview

This trial is active, not recruiting.

Conditions cancer survivor, colorectal cancer, weight changes
Treatment internet weight loss intervention
Sponsor Rutgers, The State University of New Jersey
Collaborator National Cancer Institute (NCI)
Start date July 2009
End date December 2016
Trial size 60 participants
Trial identifier NCT01032590, 130902, CDR0000660594, P30CA072720

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Arm I (12-week Internet-based weight-loss intervention): After a baseline evaluation, subjects will start a 12 week Internet-based weight-loss intervention.
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 (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.
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.

Primary Outcomes

Measure
Feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer survivors
time frame: 5 years
Impact of an Internet-based intervention on weight loss
time frame: 5 years

Secondary Outcomes

Measure
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
Potential moderators of weight loss
time frame: 5 years

Eligibility Criteria

Male or female participants from 21 years up to 120 years old.

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)

Additional Information

Official title Internet Weight Loss Intervention for Individuals Diagnosed With Colorectal Cancer
Principal investigator Elliot Coups, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.