Effects of application of electronic-patient reported outcome system on QOL and compliance in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial.

Effects of application of electronic-patient reported outcome system on QOL and compliance in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial. - Randomized controlled trial for the effects of PHR / PRO in breast cancer patients receiving adjuvant hormonal therapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044502

Enrollment

130

Registered

2021-06-11

Start date

2021-06-15

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

Interventions

Interventions: Patients evaluate side effects by PRO and adherence, and record them to application during adjuvant hormonal therapy. Control: Patients not use of the application of electronic-patient

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients who gave written informed consent. Patients who receive first line adjuvant hormonal therapy (anastrozole, retrozole, or exemestane) at Breast Center in Showa University. Patients who consult a clinic related to Showa University hospital during adjuvant hormonal therapy. Patients who can cooperate with the questionnaire.

Exclusion criteria

Exclusion criteria: Patients who had received hormonal therapy in the past. Patients with recurrent breast cancer. Patients who cannot evaluate symptoms due to mental illness or cognitive dysfunction. Patients who cannot operate smartphones or tablets. Patients who cannot use of email.

Design outcomes

Primary

Measure	Time frame
QOL evaluated by FACT-B (Functional Assessment of Cancer Therapy-Breast) at before starting adjuvant hormonal therapy and 3 months after the start of adjuvant hormonal therapy.	—

Secondary

Measure	Time frame
Communication between patients and professionals evaluated by EORTC QLQ-COMU26 at before starting adjuvant hormonal therapy and 3 months after the start of adjuvant hormonal therapy. Adherence Analyses of difference between PRO-CTCAE evaluated by patients and CTCAE v5.0-JCOG evaluated by medical stuffs (1headache,2arthralgia,3insomnia,4anxiety symptoms,5hot flushes). Disease-free survival rate	—

Countries

Japan

Contacts

Public ContactHiromi Okuyama

Showa University Department of Advanced Cancer Translational Research Institute

hiromiok@med.showa-u.ac.jp03-3784-8511

Outcome results

None listed

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