Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer - Full Text View

Sponsor:	Ontario Clinical Oncology Group (OCOG)
Collaborator:	Novartis Pharmaceuticals
Information provided by:	Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:	NCT00463489

Purpose

The primary objective of this trial is to evaluate the effect of the addition of a 2 year, centrally delivered individualized, telephone-based lifestyle intervention focusing on weight management to a mailed educational intervention on Disease Free Survival in post-menopausal women with early stage breast cancer (hormone receptor positive), BMI ≥24-<40 kg/m2, who are receiving standard letrozole adjuvant therapy.

Condition	Intervention	Phase
Breast Cancer	Behavioral: Lifestyle intervention Behavioral: Mail-based	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:

Disease-free survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
Distant disease-free survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
Weight at 6, 12, 24, 36, 48 and 60 months compared to baseline [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Health-related quality of life at 6, 12, 24, 36, 48 and 60 months compared to baseline [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Other medical endpoints such as diabetes, cardiovascular disease, arthritis, fasting biomarkers at 12 months compared to baseline (for women participating in a biospecimen substudy) [ Time Frame: 8 years ] [ Designated as safety issue: No ]
Compliance with study procedures. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2150
Study Start Date:	August 2007
Estimated Study Completion Date:	May 2018
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mail-based: Active Comparator Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.	Behavioral: Mail-based Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.
Individualized Lifestyle Intervention: Experimental Women randomized to the individualized lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.	Behavioral: Lifestyle intervention Women randomized to the lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.

Arms

Assigned Interventions

Mail-based: Active Comparator

Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.

Behavioral: Mail-based

Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.

Individualized Lifestyle Intervention: Experimental

Women randomized to the individualized lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.

Behavioral: Lifestyle intervention

Women randomized to the lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.

Detailed Description:

The primary objective of this trial is to evaluate the effect of the addition of a 2 year, centrally delivered individualized, telephone-based lifestyle intervention focusing on weight management to a mailed educational intervention on Disease Free Survival in post-menopausal women with early stage breast cancer (hormone receptor positive), BMI ≥24-<40 kg/m2, who are receiving standard letrozole adjuvant therapy. The telephone intervention will involve 19 phone calls, as well as mailings and a participant manual; women will be asked to lose up to 10% of their weight by reducing their caloric and fat intake (by 500-1000 kcal/day, 20% calories fat) and increasing their moderate physical activity (to 150-200 minutes/week). Secondary outcomes include overall survival, distant disease-free survival, weight change, health-related quality of life (HRQOL), selected non-cancer medical events and biologic factors (notably insulin). Approximately 2,150 women will be enrolled; follow-up will continue until target event rates have been met (anticipated 4-6 years after completion of the intervention). This sample size will provide 80% power (type 1 error 0.05 2-tailed) to detect a hazard ratio (HR) for DFS of 0.74-0.76 in the weight loss intervention arm.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Post-menopausal woman with a diagnosis of invasive breast cancer (T1-3,pN0-2,M0) for which definitive surgery was performed during the previous 36 months.
On adjuvant hormonal therapy with letrozole at time of randomization (either as initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal therapy).
BMI ≥ 24 kg/m2.
Medical, surgical or radiation oncologist agrees to subject participation in a diet and physical activity program.

Exclusion Criteria:

Life expectancy less than five years.
Self-reported inability to walk at least 2 blocks (at any pace).
Insulin requiring diabetes (telephone directed diet and physical activity changes would be difficult in this population without close coordination with the treating physician). Non-insulin requiring diabetics are eligible for the study.
Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
Psychiatric disorders or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
Patients on aromatase inhibitors other than letrozole at study entry.
Known recurrence of breast cancer (local, regional or distant) at any time prior to study entry.
History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Prior in situ cancer of the breast is not a reason for exclusion.
Patients not fluent in either English or French (spoken and written).
Patient unwilling or unable to provide informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463489

Locations

United States, California
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States, 02215
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Canada, British Columbia
Bcca - Csi
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, New Brunswick
Atlantic Health Sciences
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Cambridge Memorial Hospital
Cambridge, Ontario, Canada, N1R 3G2
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Grand River Regional Cancer Centere
Kitchener, Ontario, Canada, N2G 1G3
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada, P6A 2C4
Scarborough Hospital
Scarborough, Ontario, Canada, M1P 2V5
Niagara Health System
St. Catharines, Ontario, Canada, L2R 7C6
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Trillium Healthcare Centre
Toronto, Ontario, Canada, M9C 1A5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
CHUM - Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Novartis Pharmaceuticals

Investigators

Principal Investigator:

Pamela J Goodwin, MD, MSc

UHN-Mount Sinai Hospital, Toronto, ON

More Information

No publications provided

Responsible Party:	Ontario Clinical Oncology Group (OCOG) ( Dr. Pam Goodwin )
Study ID Numbers:	OCOG-2007-LISA
Study First Received:	April 19, 2007
Last Updated:	December 22, 2009
ClinicalTrials.gov Identifier:	NCT00463489 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):

lifestyle intervention
breast
cancer
adjuvant
letrozole

weight loss
BMI
post-menopausal
estrogen receptor positive
progesterone receptor positive

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs

Adjuvants, Immunologic
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on March 18, 2010