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Completed

NCT Number: NCT00156039

Randomized Trial of Follow-up Strategies in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Juravinski Cancer Centre, Hamilton, Ontario, Canada

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About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up Strategy for Breast Cancer

Behavioral

Primary outcomes

  1. Rate of clinically catastrophic events

    Time frame: Up to 5 yrs after randomization

  2. Rate of Karnofsky performance status < 70

    Time frame: Up to 5 yrs after randomization

  3. Psychosocial well being of patients in remission

    Time frame: Up to 5 yrs after randomization

Secondary outcomes

  1. Health Related Quality of Life after recurrence

    Time frame: Up to 5 yrs after randomization

  2. Survival

    Time frame: Up to 5 yrs after randomization

  3. Economic evaluation

    Time frame: Up to 5 yrs after randomization

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Canadian Breast Cancer Initiative

Registry information

Official study title

A Randomized Trial of Follow-up Strategies in Breast Cancer

Important dates

Study start
1997
Study completion
2003
First posted
Sep 12, 2005
Registry last updated
Jul 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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