Clinical trial · Interventional
Randomized Trial of Follow-up Strategies in Breast Cancer
A Randomized Trial of Follow-up Strategies in Breast Cancer
NCT00156039CI-TRIAL-00002493completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Follow-up Strategy for Breast Cancer | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Rate of clinically catastrophic events
- timeFrame
- Up to 5 yrs after randomization
- measure
- Rate of Karnofsky performance status < 70
- timeFrame
- Up to 5 yrs after randomization
- measure
- Psychosocial well being of patients in remission
- timeFrame
- Up to 5 yrs after randomization
Secondary outcomes (3)
- measure
- Health Related Quality of Life after recurrence
- timeFrame
- Up to 5 yrs after randomization
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- RESULTGrunfeld E, Levine MN, Julian JA, Coyle D, Szechtman B, Mirsky D, Verma S, Dent S, Sawka C, Pritchard KI, Ginsburg D, Wood M, Whelan T. Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care. J Clin Oncol. 2006 Feb 20;24(6):848-55. doi: 10.1200/JCO.2005.03.2235. Epub 2006 Jan 17. PMID 16418496