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| 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 |
| 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 |
| 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.
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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.
|
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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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martha Rolland | 905-527-2299 ext 42611 | mroll@mcmaster.ca |
| Contact: Jolanta Windsor | 905-527-2299 ext 42618 | windsor@mcmaster.ca |
| 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. | |||||
| Ontario Clinical Oncology Group (OCOG) |
| Novartis |
| 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 |
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