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Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer (LISA)

This study is currently recruiting participants.
Verified by Ontario Clinical Oncology Group (OCOG), September 2008

Sponsors and Collaborators: Ontario Clinical Oncology Group (OCOG)
Novartis
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

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Letrozole    Progesterone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer

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.

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,pN0-3,M0) for which definitive surgery was performed during the previous 15 months.
  • On adjuvant hormonal therapy with letrozole at study entry.
  • BMI ≥ 24 kg/m2 and < 40 kg/m2.
  • Medical, surgical or radiation oncologist willing to agree 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

Contacts
Contact: Martha Rolland     905-527-2299 ext 42611     mroll@mcmaster.ca    
Contact: Jolanta Windsor     905-527-2299 ext 42618     windsor@mcmaster.ca    

Locations
United States, California
Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center     Recruiting
      Torrance, California, United States, 90502
      Contact: Qi Yuan     310-328-7344     qyuan@labiomed.org    
      Principal Investigator: Rowan Chlebowski            
United States, Massachusetts
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Laura Shockro     617-632-5934     Laura_Shockro@dfci.harvard.edu    
      Principal Investigator: Jennifer Ligibel, M.D.            
Canada, Ontario
Mount Sinai Hospital     Recruiting
      Toronto, Ontario, Canada, M5G 1X5
      Contact: Pamela J Goodwin, MD, MSc     416-586-8605     pgoodwin@mountsinai.on.ca    
      Principal Investigator: Pamela J Goodwin, MD, MSc            
Niagara Health System     Recruiting
      St. Catharines, Ontario, Canada, L2R 7C6
      Contact: Bonnie Van Veen     905-684-7271 ext 43807     bonnie.vanveen@niagarahealth.on.ca    
      Principal Investigator: Brian Findlay, MD            
Grand River Regional Cancer Centere     Recruiting
      Kitchener, Ontario, Canada, N2G 1G3
      Contact: Mala Bahl, MD     519-749-4370     mala.bahl@grhosp.on.ca    
      Principal Investigator: Mala Bahl, MD            
Scarborough Hospital     Recruiting
      Scarborough, Ontario, Canada, M1P 2V5
      Contact: Sanda Nishimura     416-438-2911     snishimura@tsh.to    
      Principal Investigator: Richard Colwill, MD            
Ottawa Hospital Regional Cancer Centre     Recruiting
      Ottawa, Ontario, Canada, K1H 8L6
      Contact: Monica VanDam     613-737-7700 ext 70550     mvandam@toh.on.ca    
      Principal Investigator: Roanne Segal-Nadler, M.D.            
Juravinski Cancer Centre     Recruiting
      Hamilton, Ontario, Canada, L8V 5C2
      Contact: Suzanne Richardson     905-387-9495 ext 64432.     Susan.Richardson@jcc.hhsc.ca    
      Contact: Carmela Oliverio         carmela.oliverio@jcc.hhsc.ca    
      Principal Investigator: Som Mukherjee, M.D.            
Princess Margaret Hospital     Recruiting
      Toronto, Ontario, Canada, M5G 2M9
      Contact: Gail Quirt     416-586-4800 ext 5945     gquirt@mtsinai.on.ca    
      Principal Investigator: Srikala Sridhar, M.D.            
Algoma District Cancer Program     Recruiting
      Sault Ste. Marie, Ontario, Canada, P6A 2C4
      Contact: Phyllis Bettello     705-759-3434 ext 4316     bettellop@sah.on.ca    
      Principal Investigator: Silvana Spadafora, M.D.            
Thunder Bay Regional Health Science Centre     Recruiting
      Thunder Bay, Ontario, Canada, P7B 6V4
      Contact: Cindy Sinnott     807-624-7234     sinnottc@tbh.net    
      Principal Investigator: Adrien Chan, M.D.            
Sunnybrook Odette Cancer Centre     Recruiting
      Toronto, Ontario, Canada, M4N 3M5
      Contact: Heidi Gothardt     416-480-6926     heidi.gotthardt@sunnybrook.ca    
      Principal Investigator: Kathleen Prichard, M.D.            
Trillium Healthcare Centre     Recruiting
      Toronto, Ontario, Canada, M9C 1A5
      Contact: Marilyn Leighton     905-848-7147     trials@thc.on.ca    
      Contact: Lorna Beairsto     905-848-7147     trials@thc.on.ca    
      Principal Investigator: John Gapski, M.D.            
Windsor Regional Cancer Centre     Recruiting
      Windsor, Ontario, Canada, N8W 2X3
      Contact: Jane Coulter     519-253-5253 ext 58584     jane_coulter@wrh.on.ca    
      Principal Investigator: Caroline Hamm, M.D.            
Canada, Quebec
CHUM - Hotel Dieu de Montreal     Recruiting
      Montreal, Quebec, Canada, H2W 1T8
      Contact: Sylvie Beaudoin     514-890-8000 ext 15131     sylvie.beaudoin@ssss.gouv.qc.ca    
      Principal Investigator: Andre Robidoux, M.D.            

Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Novartis

Investigators
Principal Investigator:     Pamela J Goodwin, MD, MSc     UHN-Mount Sinai Hospital, Toronto, ON    
  More Information


Responsible Party:   Ontario Clinical Oncology Group (OCOG) ( Dr. Pam Goodwin )
Study ID Numbers:   OCOG-2007-LISA
First Received:   April 19, 2007
Last Updated:   September 20, 2008
ClinicalTrials.gov Identifier:   NCT00463489
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

Study placed in the following topic categories:
Body Weight
Progesterone
Skin Diseases
Weight Loss
Breast Neoplasms
Letrozole
Menopause
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008




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