Randomized Trial of Follow-up Strategies in Breast Cancer

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Follow-up Strategy for Breast Cancer

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Follow-up Strategy, Follow-up Care, Family Physician, Oncologist

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women with breast cancer on well follow-up at regional cancer centres in Ontario and Manitoba Diagnosed at least 12 months previously (range 9-15 months) Without evidence of active disease (i.e., stages IIIB and IV excluded) Free from any primary treatment complications Exclusion Criteria: Primary treatment at least 3 months previously, except for continued use of tamoxifen Still experiencing complications of primary treatment (patients will become eligible once complications resolve provided they are within the 6 month window) Unable to identify an acceptable family physician to provide follow-up Language or literacy skills inconsistent with completing questionnaires Unable to comply with study protocol including completion of questionnaires Previously enrolled in a study which requires continued follow-up in specialist or peripheral clinics Actively followed at a cancer centre for another primary cancer

Sites / Locations

Juravinski Cancer Centre
Kingston Regional Cancer Centre
Ottawa Hospital - Integrate Cancer Program
Thunder Bay Regional Health Sciences Centre
Toronto Sunnybrook Hospital

Outcomes

Primary Outcome Measures

Rate of clinically catastrophic events

Rate of Karnofsky performance status < 70

Psychosocial well being of patients in remission

Secondary Outcome Measures

Health Related Quality of Life after recurrence

Survival

Economic evaluation

Full Information

NCT ID

NCT00156039

First Posted

September 8, 2005

Last Updated

July 24, 2009

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Canadian Breast Cancer Initiative

1. Study Identification

Unique Protocol Identification Number

NCT00156039

Brief Title

Randomized Trial of Follow-up Strategies in Breast Cancer

Official Title

A Randomized Trial of Follow-up Strategies in Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

January 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Canadian Breast Cancer Initiative

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life.

Detailed Description

see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Follow-up Strategy, Follow-up Care, Family Physician, Oncologist

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

968 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Follow-up Strategy for Breast Cancer

Primary Outcome Measure Information:

Title

Rate of clinically catastrophic events

Time Frame