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

NCT02935920 | Completed

• 1 other identifier: OOBS
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

PRO, follow up

Outcome Measures

Primary Outcomes (1)

• The difference in PREM (patient reported experience measure) as reported by patients in the individualized and standard follow-up groups, respectively

  Every three months the patients in both groups are requested to fill out a patient satisfaction questionnaire (PEQ) concerning their follow-up program. A single item with scores between 1 and 5 will be used to evaluate the difference between the 2 groups (1 is very satisfied and 5 is very dissatisfied)

  2 years

Secondary Outcomes (5)

• Comparison of resources spent on individualized follow-up based on PRO-data and standard follow-up.

  2 years

• The difference in CollaboRATE-score between the individualized and standard follow-up.

  2 years

• Comparison of Health related quality of life in the individualized follow-up versus standard follow-up.

  2 years

• Elucidation of issues of importance and concern to postmenopausal woman with breast cancer in adjuvant endocrine therapy during follow-up after primary treatment. What symptoms and side effects trouble them most during follow-up?

  2 years

• Evaluation of current information level during primary treatment

  2 years

Study Arms (2)

Individual, tailored follow-up

EXPERIMENTAL

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.

Behavioral: Individualized, tailored follow-up program

Standard follow-up

NO INTERVENTION

Scheduled clinical examination every six months throughout the course of adjuvant treatment. Performed by a doctor or nurse.

Interventions

Individualized, tailored follow-up program BEHAVIORAL

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

Individual, tailored follow-up

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle hospital, Department of Oncology

Vejle, Region of Southen Denmark, 7100, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Karina D. Steffensen, MD, PhD

  Vejle Hospital

  STUDY CHAIR

• Cathrine L. Riis, MD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: October 18, 2016
• Study Start: April 11, 2016
• Primary Completion: June 30, 2019
• Study Completion: December 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)