NCT01032590

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

7.7 years

First QC Date

December 13, 2009

Last Update Submit

March 2, 2017

Conditions

Cancer SurvivorColorectal CancerWeight Changes

Keywords

weight changescancer survivorstage I colon cancerstage II colon cancerstage III colon cancerstage I rectal cancerstage II rectal cancerstage III rectal cancer

Outcome Measures

Primary Outcomes (2)

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

    5 years

  • Impact of an Internet-based intervention on weight loss

    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

    5 years

  • Potential moderators of weight loss

    5 years

Study Arms (2)

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.

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.

Behavioral: Internet weight loss intervention

Interventions

Internet weight loss interventionBEHAVIORAL

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.

Arm IArm II

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsBody Weight ChangesColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elliot Coups, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2009

First Posted

December 15, 2009

Study Start

July 1, 2009

Primary Completion

March 2, 2017

Study Completion

March 2, 2017

Last Updated

March 6, 2017

Record last verified: 2017-03

Locations

US(2)