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A Study on Optimizing Follow-up for Postmenopausal Women With Breast Cancer Treated With Adjuvant Endocrine Therapy

NCT02935920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-02-05

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Individualized, tailored follow-up program

Individualized follow-up in the context of shared decision making, with the use of PRO-data to evaluate the patient needs of consultations.

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Karina D. Steffensen, MD, PhD · Vejle Hospital

  • Cathrine L. Riis, MD · Vejle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
95 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-11
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935920 on ClinicalTrials.gov