Impact of ePRO-based follow-up system (Pink Ribbon Diary) on quality of life and treatment adherence in patients with breast cancer receiving CDK4/6 inhibitors: a single center, randomized controlled study

Not Applicable

• Conditions: Breast Cancer; Advanced or recurrent breast cancer, CDK4/6 inhibitors; D001943

• Registration Number: JPRN-jRCT1030220626
• Lead Sponsor: Ozeki Rie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1) The age of registration is 20 years or older.
2) Advanced or recurrent breast cancer patients taking CDK4/6 inhibitors (abemaciclib or palbociclib)
3) ECOG performance status (PS): 0-1
4) Written informed consent is obtained from the patient.

Exclusion Criteria

1) Patients with apparent difficulty in self-assessing symptoms due to psychological disorder or cognitive impairment.
2) Patients unable to operate a mobile device such as a smartphone or tablet device.
3) Patients who are deemed unsuitable as subjects by the physician in charge.
4) In addition, patients who are judged to be unsuitable for participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified