Lifestyle Intervention for High Risk Cancer Survivors

NCT01508273 | Completed

• 3 other identifiers: 2011-0743K01CA158000NCI-2014-02453
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Health Behaviors of Breast Cancer Survivors

  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).

  6 months

Secondary Outcomes (1)

• Home-Based Exercise Feasibility

  6 months

Study Arms (3)

Exercise Intervention Program Group

EXPERIMENTAL

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; Behavioral: Website; Behavioral: Survey

Sedentary Behavior and Dietary Intervention Group

OTHER

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; Behavioral: Survey

Chair-based Study Group

EXPERIMENTAL

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; Behavioral: Self-Report Assessments

Interventions

Exercise Program BEHAVIORAL

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.

Exercise Intervention Program Group

Website BEHAVIORAL

Website access given that allows participant to track exercise behavior and help to set goals.

Exercise Intervention Program Group; Sedentary Behavior and Dietary Intervention Group

Exercise DVD BEHAVIORAL

Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.

Chair-based Study Group

Survey BEHAVIORAL

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.

Exercise Intervention Program Group; Sedentary Behavior and Dietary Intervention Group

Self-Report Assessments BEHAVIORAL

Self-report assessments given about quality of life and physical assessments of balance and coordination.

Chair-based Study Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

The University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

Memorial Herman Health Care System

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Resistance Training; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Richard A. Hajek, PHD, MS, BA

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 11, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 2, 2016

Record last verified: 2016-12

Locations

US (3)