Clinical trial · Interventional
A Study on Optimizing Follow-up for Postmenopausal Women With Breast Cancer Treated With Adjuvant Endocrine Therapy
- 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)
Background: In February 2015 the Danish Health and Medicines Authority published new clinical guidelines describing how cancer patients should be followed. It is recommended that patients receiving specific oncological treatment such as endocrine therapy be followed at the department of oncology responsible for the treatment and providing the medication. There is no evidence that routine examinations improve overall survival after breast cancer. Mammography is the only specific examination to be offered to asymptomatic women after treatment for breast cancer Aims of the study: The hypothesis is that individualized follow-up with the introduction of Patient Reported Outcome (PRO) data will help postmenopausal women regain control of health related self-care and encourage them to a larger extent to take part in their follow-up after cancer treatment. This is believed to improve the health related quality of life and increase the positive experience of the follow-up program. Design: Patients are randomly assigned to the department's standard control program or an individualized solution in the context of shared decision making. PRO data will be used to evaluate the patient's need for consultations. Primary outcome: Evaluation of the experience and feasibility of PRO data in connection with individualized follow-up of postmenopausal women with breast cancer. Systematically applying PRO data we will uncover patient needs, empower the patients to take part in shared decision making, and improve the current follow-up in the sense of a more patient-centered care and tailored follow-up.
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 |
|---|---|---|---|
| Individualized, tailored follow-up program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Individual, tailored follow-up
- description
- Patient symptoms are evaluated by the use of PRO-data to uncover the needs of a consultation. The outcome of the questionnaire is used to customize the follow-up program to the individual patient.
- interventionNames
- Behavioral: Individualized, tailored follow-up program
- type
- NO_INTERVENTION
- label
- Standard follow-up
- description
- Scheduled clinical examination every six months throughout the course of adjuvant treatment. Performed by a doctor or nurse.
Primary outcomes (1)
- measure
- The difference in PREM (patient reported experience measure) as reported by patients in the individualized and standard follow-up groups, respectively
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal at the time of diagnosis (menostasis \> 12 months. Bilateral salpingo-oophorectomy) * Complete disease remission after primary operation * Histologically confirmed hormone-receptor positive breast cancer, 1% or more of the tumor cells express hormone receptors * High-risk profile with a 10-year recurrence of more than 10% * Planned adjuvant endocrine therapy regardless of other adjuvant therapy to be initiated within 1 month or initiated within the last 9 months. * Written and verbally informed consent * Able to read and speak Danish * Access to a computer and an email-account Exclusion Criteria: * Patient followed regularly as part of a research protocol * Women postmenopausal due to surgery on the ovaries/uterus age \< 50 * Prognostic low grade risk of recurrence (tumor size 10 mm or less, lymph node negative, ductal carcinoma grade 1 and lobular carcinoma grade 1 or 2)
References
Publications (0)
Data not yet available