Telephone Counseling-Mailed Materials Versus Internet Interventions in Overweight Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01311856
First received: March 4, 2011
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Colorectal Cancer
Prostate Cancer
Behavioral: Standard Arm (mail/telephone)
Behavioral: Internet Arm
Behavioral: Surveys and Questionnaires
Behavioral: Exercise and Diet

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telephone Counseling-Mailed Materials Versus Internet Weight Management Interventions in Overweight Cancer Survivors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Recruitment Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Drop-Out Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Standard Arm (mail/telephone) Behavioral: Standard Arm (mail/telephone)
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.
Behavioral: Surveys and Questionnaires
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.
Behavioral: Exercise and Diet
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 Arm Behavioral: Internet Arm
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.
Behavioral: Surveys and Questionnaires
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.
Behavioral: Exercise and Diet
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. 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);
  2. No history of other cancers (excluding non-melanoma skin cancer);
  3. Age 18 years of age or older;
  4. BMI greater than or equal to 25;
  5. Has access to a computer with high-speed internet;
  6. Has access to a telephone for possible multiple counseling sessions;
  7. Living in the Houston area (Harris county or a contiguous county);
  8. 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;
  9. Able to come to MD Anderson for assessments at baseline and six-month intervals;
  10. Has completed primary cancer treatment and is at least 3 months from surgery (if elected);
  11. Able to read and speak English; and
  12. Able to provide informed consent.

Exclusion Criteria:

  1. Have pre-existing medical conditions that preclude adherence to an unsupervised exercise program or a low-fat, high fruit and vegetable (F&V) diet;
  2. Persons using walker or wheelchair/scooter;
  3. Women who are pregnant; and
  4. Patients that are identified as having metastatic disease at the time of recruitment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311856

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PHD, BA, MPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01311856     History of Changes
Other Study ID Numbers: 2009-0504
Study First Received: March 4, 2011
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Behavioral intervention
Exercise
Physical Assessment
Questionnaire
Survey
Telephone counseling
Internet interventions
Overweight cancer survivors
Exercise and weight management program

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014