NCT01311856

Brief Summary

The goal of this behavioral research study is to learn if an internet or phone based exercise and weight management program can help cancer survivors to lose weight and change their eating and exercise behavior.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

9 years

First QC Date

March 4, 2011

Last Update Submit

May 16, 2019

Conditions

Breast CancerColorectal CancerProstate Cancer

Keywords

Behavioral interventionExercisePhysical AssessmentQuestionnaireSurveyTelephone counselingInternet interventionsOverweight cancer survivorsExercise and weight management program

Outcome Measures

Primary Outcomes (1)

  • Recruitment Rate

    Recruitment and drop-out rates in both treatment groups used to assess internal validity of study by comparison of drop-out between two study conditions, and drop-outs to completers.

    6 months

Secondary Outcomes (1)

  • Drop-Out Rate

    6 months

Study Arms (2)

Standard Arm (mail/telephone)

Behavioral: Standard Arm (mail/telephone)Behavioral: Surveys and QuestionnairesBehavioral: Exercise and Diet

Internet Arm

Behavioral: Internet ArmBehavioral: Surveys and QuestionnairesBehavioral: Exercise and Diet

Interventions

Standard Arm (mail/telephone)BEHAVIORAL

Participants will receive print materials on diet and exercise, telephone counseling calls (3 weekly calls, 2 semi-weekly calls, 4 monthly calls; 15-30 minutes in length), and customized mailed progress reports every 6 weeks to adhere to diet and exercise recommendations.

Standard Arm (mail/telephone)
Internet ArmBEHAVIORAL

Participants will access print information online. Participants will also participate in a discussion forum facilitated by the intervention staff, have the opportunity to email questions directly to the intervention staff, and receive progress reports every 6 weeks by email.

Internet Arm
Surveys and QuestionnairesBEHAVIORAL

9 online surveys to be completed before intervention sessions. After 14 weeks on study, questionnaires will be mailed for completion at home and mailed back to the study staff.

Internet ArmStandard Arm (mail/telephone)
Exercise and DietBEHAVIORAL

15 minutes of strength exercise every other day, \>30 minutes of walking or other moderate-intensity exercise on 5 or more days of the week. Diet recommendations for both groups.

Internet ArmStandard Arm (mail/telephone)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants recruited from UT MD Anderson Cancer Center clinics in Houston, Texas

You may qualify if:

  • Diagnosis of either loco-regional breast cancer (Stages 0 - IIIA), colon cancer (Stages I - II), endometrial cancer (Stages I - IIIa) or prostate cancer (Stages I - II);
  • No history of other cancers (excluding non-melanoma skin cancer);
  • Age 18 years of age or older;
  • BMI greater than or equal to 25;
  • Has access to a computer with high-speed internet;
  • Has access to a telephone for possible multiple counseling sessions;
  • Living in the Houston area (Harris county or a contiguous county);
  • Has agreed in the protocol 2009-0544 survey to be re-contacted about studies (for breast, prostate, and colon cancer survivors), or is an endometrial cancer survivor seen seen by an MD Anderson gynecologic oncologist at MD Anderson or an outreach site;
  • Able to come to MD Anderson for assessments at baseline and six-month intervals;
  • Has completed primary cancer treatment and is at least 3 months from surgery (if elected);
  • Able to read and speak English; and
  • Able to provide informed consent.

You may not qualify if:

  • Have pre-existing medical conditions that preclude adherence to an unsupervised exercise program or a low-fat, high fruit and vegetable (F\&V) diet;
  • Persons using walker or wheelchair/scooter;
  • Women who are pregnant; and
  • Patients that are identified as having metastatic disease at the time of recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Cox M, Basen-Engquist K, Carmack CL, Blalock J, Li Y, Murray J, Pisters L, Rodriguez-Bigas M, Song J, Cox-Martin E, Demark-Wahnefried W. Comparison of Internet and Telephone Interventions for Weight Loss Among Cancer Survivors: Randomized Controlled Trial and Feasibility Study. JMIR Cancer. 2017 Sep 27;3(2):e16. doi: 10.2196/cancer.7166.

    PMID: 28954716DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsProstatic NeoplasmsMotor Activity

Interventions

Surveys and QuestionnairesExerciseDiet

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Karen Basen-Engquist, PHD, BA, MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 10, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2020

Study Completion

March 1, 2021

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

US(1)