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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Cancer Survivor, Colorectal Cancer, Weight Changes
- 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 group | Role | What they receive |
|---|---|---|
| Arm I | 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. Receives: Behavioral: Internet weight loss intervention |
| Arm II | 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. Receives: Behavioral: Internet weight loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing an Internet-based weight-loss intervention for colorectal cancer survivors
Measured: 5 years
Impact of an Internet-based intervention on weight loss
Measured: 5 years
Secondary outcomes (2)
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
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.
- First posted15 Dec 2009 (estimated)
- Study startJul 2009
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Why it stopped: Trial was only opened at RCINJ for analysis of data, no patient enrollment took place here.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Elliot Coups, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Weight Loss Intervention for Individuals Diagnosed With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01032590
- Acronym / sponsor ID
- 130902
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was only opened at RCINJ for analysis of data, no patient enrollment took place here.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- Jul 2009
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Behavioral: Internet weight loss interventionArm 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 | Active comparator | Behavioral: Internet weight loss interventionArm 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. |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet weight loss interventionParticipants 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. | Behavioural | Arm I, Arm II |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Coups, PhD principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
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.