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

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 - JPRO-B

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1030220626

Enrollment

Registered

2023-02-09

Start date

2023-02-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Advanced or recurrent breast cancer, CDK4/6 inhibitors

Interventions

Patients to report physical conditions and compliance by using electronic patient diary (Pink Ribbon Diary)

D063868

Electronic Patient Outcome Assessment

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Change in Global health status/QOL (EORTC QLQ-C30)	—

Secondary

Measure	Time frame
(1)RDI (2)Other domains of EORTC QLQ-C30 (3)Number of days missed medication (4)PDC (proportion of days covered) (5)MMAS-8 (Morisky Medication Adherence Scale) (6)Questionnaire on use of Pink Ribbon Diary (7) Occurrence of adverse events (8)Incidence of missed medication	—

Contacts

Public ContactRie Ozeki

Juntendo University School of Medicine

r.ozeki.gs@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026