Ottawa Hospital Research Institute
After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.
Breast Cancer
On-demand personalized follow-up care
Guideline-based follow-up care (standard of care)
Phase 4
After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. The frequency of follow-up varies between and within different institutions. To date, no de-escalation strategy has appropriately evaluated patient reported outcomes such as quality of life or perception of care. There has been a growing body of evidence that de-intensification of follow-up is safe, effective and reduces costs for both patients and the health care system. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 264 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Health Services Research |
| Official Title : | A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer (REaCT-Wellness) |
| Actual Study Start Date : | August 19, 2022 |
| Estimated Primary Completion Date : | July 2026 |
| Estimated Study Completion Date : | July 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: On-demand personalized follow-up care On-demand personalized follow-up care (on-demand access to a Wellness Beyond Cancer Program (WBCP) nurse and an annual follow-up by telephone with WBCP nurse following the patient's annual mammogram). Both groups of participants will have yearly mammograms (current standard of care) organized by their healthcare provider. |
Other: On-demand personalized follow-up care |
|
Active Comparator: Guideline-based follow-up care Guideline-based follow-up care (i.e. current standard of care). Both groups will have yearly mammograms (current standard of care) organized by their healthcare provider. |
Other: Guideline-based follow-up care (standard of care) |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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Not yet recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H8M2