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:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Contacts

Contact: Jolanta Windsor	905-527-2299 ext 42618	windsor@mcmaster.ca
Contact: Erin McGean	905-527-2299 ext 42656	mcgeane@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.
Beth Israel Deaconess Medical Centre	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kasey Componeschi 617-667-3347 kcompone@bidmc.harvard.edu
Principal Investigator: George Blackburn
United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 98109
Contact: Kara Kendall 206-667-4376 kkendall@fhcrc.org
Principal Investigator: Julie Gralow
Canada, British Columbia
BCCA - CSI	Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Lisa Faure 250-712-3900 ext 6743 lfaure@bccancer.bc.ca
Principal Investigator: Susan Ellard
Canada, New Brunswick
Atlantic Health Sciences	Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Sharon Turnell 506-648-6890 oncct@reg2.health.nb.ca
Principal Investigator: Margot Burnell
Canada, Ontario
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Pamela J Goodwin, MD, MSc 416-586-8605 pgoodwin@mtsinai.on.ca
Principal Investigator: Pamela J Goodwin, MD, MSc
Ottawa Hospital Regional Cancer Centre	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Joanne Roach 613-737-7700 ext 40310 jroach@toh.on.ca
Principal Investigator: Roanne Segal-Nadler, M.D.
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: Richard Colwill 416-439-5866 rcolwill@tsh.to
Principal Investigator: Richard Colwill, MD
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
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.
London Regional Cancer Centre	Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Pat Furlong 519-685-8618 Patricia.Furlong@lhsc.on.ca
Principal Investigator: Ted Vandenberg
Cambridge Memorial Hospital	Recruiting
Cambridge, Ontario, Canada, N1R 3G2
Contact: Teresa Krajewski 519-740-4940 tkrajewski@cmh.org
Contact: Stephanie Evans 519-740-4940 sevans@cmh.org
Principal Investigator: Edmond Chouinard
St. Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Daisy Dastur 416-864-5354 dasturd@smh.toronto.on.ca
Principal Investigator: Rashida Haq
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.
Hopital Charles LeMoyne	Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Martin Caplette 450-466-5000 ext 3226 martin.caplette@rrsss16.gouv.qc.ca
Principal Investigator: Jean Latreille

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:	October 27, 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 November 20, 2009