Breast Cancer
Conditions
Keywords
Well Follow-up, Follow-up Interval
Brief summary
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.
Detailed description
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.
Interventions
OTHEROn-demand personalized follow-up care
On-demand personalized follow-up care (on demand access to a WBCP nurse and an annual follow-up by telephone.
OTHERGuideline-based follow-up care (standard of care)
Follow-up care based on current standard of care guidelines.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being referred to the Wellness Beyond Cancer Program (WBCP) for routine follow-up after completion of acute phase of treatment for invasive breast cancer
Exclusion criteria
* History of prior invasive breast cancer, recurrent brest cancer or metastatic breast cancer * Currently receiving zoledronate, LHRH (Gonadotropin-releasing hormone) or abemaciclib
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 24 months after randomization | Health-Related Quality of Life as determined by the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire designed to measure four domains of Health related quality of life (HRQOL) in cancer patients: physical, social, emotional and functional well-being. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of recurrence | 24 months after randomization | Fear of recurrence will be measured by the Functional Assessment of Cancer Therapy - Fear of Recurrence (FACT-FRQ) questionnaire. It consists of 3 questions suggested by David Cella at FACIT (Functional Assessment of Chronic Illness Therapy), that were adapted from Vickberg's Concerns about Recurrence (CARS) questionnaire. |
| Anxiety levels | 24 months after randomization | Anxiety levels as determined by the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS questionnaire measures anxiety and depression, which commonly coexist. It is comprised of seven questions for anxiety and seven questions for depression. |
| Treatment related toxicity concerns | 24 months after randomization | Treatment related toxicity concerns as assessed using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire. The FACT-ES questionnaire is a validated sub scale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. FACT-ES consists of 46 items on a 5 point Likert type scale ranging from 0 (not at all) to 4 (very much). It is designed to measure five domains of health: physical well-being, social/family well-being, emotional well-being, functional well being and endocrine symptom subscale. |
| Recurrence-free survival | 24 months after randomization | Measured by the number of participants free of breast cancer recurrence after 24 months of follow-up. |
| Patient visits | 24 months after randomization | Number of patient reported visits to different healthcare providers using a Patient Follow-up Questionnaire. The follow-up questionnaire consists of questions that assess the number of follow up visits a participant has had and also the type of healthcare provider the follow-up visits were with. |
| Cost-effectiveness | 24 months after randomization | Incremental cost-effectiveness rations (cost per one quality-adjusted life year (QALY) gained. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMark Clemons, MD
Ottawa Hospital Research Institute
PRINCIPAL_INVESTIGATORJohn Hilton, MD
Ottawa Hospital Research Institute
Outcome results
None listed