Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer (LISA)
This study is ongoing, but not recruiting participants.
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00463489
First received: April 19, 2007
Last updated: October 9, 2012
Last verified: October 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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:
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: | May 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Experimental: Individualized Lifestyle Intervention
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) |
| ClinicalTrials.gov Identifier: | NCT00463489 History of Changes |
| Other Study ID Numbers: | OCOG-2007-LISA |
| Study First Received: | April 19, 2007 |
| Last Updated: | October 9, 2012 |
| 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:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013