Lifestyle Intervention for High Risk Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01508273
First received: January 9, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

The goal of this behavioral research study is to find out more about the health behaviors of cancer survivors. Researchers want to understand the cultural, social, and environmental factors related to physical activity and personal diet. Researchers also want to learn if cancer survivors who take part in lifestyle interventions have better overall health and quality of life than those who do not take part in these interventions.


Condition Intervention
Breast Cancer
Behavioral: Exercise Program
Behavioral: Website
Behavioral: Exercise DVD
Behavioral: Survey
Behavioral: Self-Report Assessments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Health Behaviors of Breast Cancer Survivors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Data collected from mail-based surveys (n = 1,000) to assess intervention preferences, physical activity (PA), health related quality of life (HRQOL), and mediators of change (e.g., self-efficacy).


Secondary Outcome Measures:
  • Home-Based Exercise Feasibility [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rates of recruitment (% recruited out of the total number invited), retention (% completing the 6-month intervention), adherence (% completing 100% of study requirements), satisfaction, adverse events, and barriers to a home-based aerobic and resistance-training program.


Estimated Enrollment: 600
Study Start Date: May 2012
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Intervention Program Group
At baseline study visit, participant shown how to complete the physical exercises performed while on study. Pedometer received to track physical activity. Resistance training bands given to use as part of the home-based exercise program. At the baseline study visit, directions received on how to use the study website. Access given to website that will allow tracking of exercise behavior and help set goals. Access given to an internet-based curriculum that will help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participant asked to visit website every week. Participant records activity and the number of steps taken every day on the website. Survey completed monthly about attitudes and beliefs about physical activity.
Behavioral: Exercise Program
Resistance training bands, guidebook, and pedometer given at baseline visit. Internet-based curriculum access given to teach goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Access given website that will allow participant to track exercise behavior and help set goals.
Behavioral: Website
Website access given that allows participant to track exercise behavior and help to set goals.
Behavioral: Survey

Exercise Intervention Program Group : Survey completion monthly about attitudes and beliefs about physical activity.

Sedentary Behavior and Dietary Intervention Group: Survey completion monthly attitudes and beliefs about sedentary behavior and dietary intake.

Sedentary Behavior and Dietary Intervention Group
Access given to internet-based curriculum to help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participants read information about improving the quality of their diet and cutting back on sedentary behavior. Participants record on the website how much television watched and how many fruits and vegetables eaten every day. Survey completed monthly about attitudes and beliefs about sedentary behavior and dietary intake.
Behavioral: Website
Website access given that allows participant to track exercise behavior and help to set goals.
Behavioral: Survey

Exercise Intervention Program Group : Survey completion monthly about attitudes and beliefs about physical activity.

Sedentary Behavior and Dietary Intervention Group: Survey completion monthly attitudes and beliefs about sedentary behavior and dietary intake.

Experimental: Chair-based Study Group
Patients participate in chair-based exercise study. Participants receive chair-based exercise DVD. Chair-based exercise program participation for a total of 8 weeks. Participants receive self-report assessments about quality of life and asked to participate in physical assessments of their balance and coordination.
Behavioral: Exercise DVD
Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.
Behavioral: Self-Report Assessments
Self-report assessments given about quality of life and physical assessments of balance and coordination.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18-80 years old at diagnosis
  2. diagnosed with operable invasive cancer
  3. have access to high speed internet
  4. Phase 2 only: be currently sedentary (i.e., engage in < or = 60 minutes of purposeful moderate-intensity PA/week)
  5. Phase 2 only: be overweight or obese (i.e., have a body mass index (BMI) > or = 25 kg/m^2)
  6. speak English

Exclusion Criteria:

  1. watch less than 3 hours of television per day
  2. be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise)
  3. participants answering 'Yes' to one or more of the questions on the physical activity readiness questionnaire (PAR-Q) will need to obtain approval from a physician before they can participate in the intervention.
  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: NCT01508273

Contacts
Contact: Richard A. Hajek, PHD, MS, BA 713-563-2764

Locations
United States, Texas
The University of North Texas Health Science Center Recruiting
Fort Worth, Texas, United States, 76107
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Memorial Herman Health Care System Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Richard A. Hajek, PHD, MS, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01508273     History of Changes
Other Study ID Numbers: 2011-0743, K01CA158000
Study First Received: January 9, 2012
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Breast Cancer Survivors
High risk cancer survivors
Stage II to IIIC breast cancer
African American
AA
Hispanic
Non-Hispanic White
Operable invasive breast carcinoma
Aerobic and resistance training
Pedometer
Telephone Counseling Calls
Physical activity report
PAR
Functional Assessment of Cancer Therapy-Breast
FACT-B
Health related quality of life
HRQOL

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014