Lifestyle Intervention for High Risk Cancer Survivors

• ClinicalTrials.gov Identifier: NCT01508273
• Recruitment Status: Completed
• First Posted: January 11, 2012
• Last Update Posted: December 2, 2016
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Breast Cancer	Behavioral: Exercise Program; Behavioral: Website; Behavioral: Exercise DVD; Behavioral: Survey; Behavioral: Self-Report Assessments	Not Applicable

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: May 2012
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Health Behaviors of Breast Cancer Survivors [ Time Frame: 6 months ]
   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 :

1. Home-Based Exercise Feasibility [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes 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

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 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT01508273 History of Changes
• Other Study ID Numbers: 2011-0743; K01CA158000 ( U.S. NIH Grant/Contract ); NCI-2014-02453 ( Registry Identifier: NCI CTRP )
• First Posted: January 11, 2012
• Last Update Posted: December 2, 2016
• Last Verified: December 2016

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