Lifestyle Intervention for High Risk Cancer Survivors - Full Text View

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness Health Checkup Healthy Living

U.S. FDA Resources

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:

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

Exclusion Criteria:

watch less than 3 hours of television per day
be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise)
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

Locations


United States, Texas
The University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
Memorial Herman Health Care System
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Richard A. Hajek, PHD, MS, BA	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01508273 History of Changes
Other Study ID Numbers:	2011-0743, K01CA158000, NCI-2014-02453
Study First Received:	January 9, 2012
Last Updated:	February 12, 2015
Health Authority:	United States: Institutional Review Board United States: Federal Government

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 Breast Diseases Neoplasms Neoplasms by Site Skin Diseases

ClinicalTrials.gov processed this record on March 02, 2015