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Cancer SurvivorNCT01032590

Internet-Based Weight-Loss Program for Colorectal Cancer Survivors

A study testing Internet weight loss intervention in people with Cancer Survivor and Colorectal Cancer, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 120 years
Conditions the study is for
Cancer Survivor, Colorectal Cancer, Weight Changes
What is being tested?
Internet weight loss intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jul 2009to 2 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania

Other trials in United States

About this study

Official title: Internet Weight Loss Intervention for Individuals Diagnosed With Colorectal Cancer

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.

Read the 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.

Being tested
Internet weight loss intervention
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
Medical subject headings
Colorectal Neoplasms, Body Weight Changes, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet weight loss interventionBehavioural

    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.

Study groups in NCT01032590
Study groupRoleWhat they receive
Arm IExperimentalArm I (12-week Internet-based weight-loss intervention): After a baseline evaluation, subjects will start a 12 week Internet-based weight-loss intervention.
Receives: Behavioral: Internet weight loss intervention
Arm IIActive comparatorArm 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.
Receives: Behavioral: Internet weight loss intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer survivors

    Measured: 5 years

  2. Impact of an Internet-based intervention on weight loss

    Measured: 5 years

Secondary outcomes (2)
  1. 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

    Measured: 5 years

  2. Potential moderators of weight loss

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2009 (estimated)
  2. Study startJul 2009
  3. Primary completion2 Mar 2017
  4. Study completion2 Mar 2017

Why it stopped: Trial was only opened at RCINJ for analysis of data, no patient enrollment took place here.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01032590
Sponsor's protocol ID
130902
Other IDs
P30CA072720, CDR0000660594
Status last verified
Mar 2017
First submitted
13 Dec 2009
Last updated
6 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Internet weight loss intervention in people with Cancer Survivor and Colorectal Cancer, run by Rutgers, The State University of New Jersey at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer survivors (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.

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