Lifestyle Intervention for High Risk Cancer Survivors
This study is currently recruiting participants.
Verified January 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01508273
First received: January 9, 2012
Last updated: January 28, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: Telephone Counseling Calls Behavioral: Standard Care Behavioral: Health Behavior Survey |
| 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
14 telephone counseling calls, a pedometer to track physical activity, self-monitoring logs, resistance-training bands, and a culturally tailored and adapted version of an exercise guide for breast cancer survivors.
|
Behavioral: Exercise Program
Resistance training bands, guidebook, and pedometer given at baseline visit.
Behavioral: Telephone Counseling Calls
14 telephone counseling calls. The average call will last about 15-30 minutes.
|
|
Standard of Care Group
Culturally-tailored workbook of study materials within a month of completing 6-month follow-up. Update cards and newsletters received on topics such as coping with cancer and how to find resources if participant has cancer.
|
Behavioral: Standard Care
Monthly newsletters.
|
|
Experimental: Feasibility Group
Phase I mail survey.
|
Behavioral: Health Behavior Survey
One time completion of mailed survey.
|
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 breast carcinoma
- not currently undergoing chemotherapy or radiation treatment. Women taking hormone therapy will not be excluded from the study
- >= 1 year out from diagnosis
- have no evidence of recurrent disease or new primary disease
- be accessible by telephone
- Phase 2 only: 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 or Spanish
Exclusion Criteria:
- Phase 2 only: have objective evidence of recurrent disease
- 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.
- We opted to not include participants over the age of 70 because previous research has shown that the exercise habits of women breast cancer survivors in this age range are different from those of younger women. In addition, women over the age of 70 may have other health challenges that would prevent them from being active at the levels that we are recommending.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508273
Contacts
| Contact: Raheem J. Paxton, PHD | 713-563-2735 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Memorial Herman Health Care System | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Raheem J. Paxton, PHD | 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 |
| Study First Received: | January 9, 2012 |
| Last Updated: | January 28, 2013 |
| 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 May 16, 2013