Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer
LISA
1 other identifier
interventional
338
2 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Aug 2007
Longer than P75 for not_applicable breast-cancer
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 26, 2018
September 1, 2018
10.8 years
April 19, 2007
September 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
8 years
Secondary Outcomes (6)
Overall survival
8 years
Distant disease-free survival
8 years
Weight at 6, 12, 24, 36, 48 and 60 months compared to baseline
5 years
Health-related quality of life at 6, 12, 24, 36, 48 and 60 months compared to baseline
5 years
Other medical endpoints such as diabetes, cardiovascular disease, arthritis, fasting biomarkers at 12 months compared to baseline (for women participating in a biospecimen substudy)
8 years
- +1 more secondary outcomes
Study Arms (2)
Mail-based
ACTIVE COMPARATORParticipants 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
EXPERIMENTALWomen 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Patients not fluent in either English or French (spoken and written).
- Patient unwilling or unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ontario Clinical Oncology Group (OCOG)lead
- Novartis Pharmaceuticalscollaborator
Study Sites (21)
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02215, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Bcca - Csi
Kelowna, British Columbia, V1Y 5L3, Canada
Cambridge Memorial Hospital
Cambridge, Ontario, N1R 3G2, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Grand River Regional Cancer Centere
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6A 2C4, Canada
Scarborough Hospital
Scarborough Village, Ontario, M1P 2V5, Canada
Niagara Health System
St. Catharines, Ontario, L2R 7C6, Canada
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Trillium Healthcare Centre
Toronto, Ontario, M9C 1A5, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1, Canada
CHUM - Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8, Canada
Related Publications (1)
Goodwin PJ, Segal RJ, Vallis M, Ligibel JA, Pond GR, Robidoux A, Blackburn GL, Findlay B, Gralow JR, Mukherjee S, Levine M, Pritchard KI. Randomized trial of a telephone-based weight loss intervention in postmenopausal women with breast cancer receiving letrozole: the LISA trial. J Clin Oncol. 2014 Jul 20;32(21):2231-9. doi: 10.1200/JCO.2013.53.1517. Epub 2014 Jun 16.
PMID: 24934783BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela J Goodwin, MD, MSc
UHN-Mount Sinai Hospital, Toronto, ON
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2007
First Posted
April 20, 2007
Study Start
August 1, 2007
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
September 26, 2018
Record last verified: 2018-09