Qol Pharmacy Clinical Study of usefulness of outpatient cancer patients PRO-CTCAE for continuous pharmacy management: multicenter joint research

Qol Pharmacy Clinical Study of usefulness of outpatient cancer patients PRO-CTCAE for continuous pharmacy management : multicenter joint research - QOLMIND study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046324

Enrollment

100

Registered

2021-12-13

Start date

2021-12-13

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

Malignancy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Currently receiving cancer therapy. 2.ECOG PS 0 to 2. 3.Sufficient language ability to understand and complete the questionnaire without assistance. 4.Provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1.Those who have difficulty in evaluating their own symptoms. 2.Those who have cognitive problems that make it difficult to evaluate their symptoms on their own. 3.Those who have mental problems that make it difficult to evaluate their symptoms on their own. 4.Those who are judged by the pharmacy pharmacist to be difficult to implement continuous pharmacy management guidance. 5.Those whose native language is not Japanese.

Design outcomes

Primary

Measure	Time frame
In the computerized PRO-CTCAE group and telephone follow-up group, the average value of the number of life guidance, medication guidance, information provided to medical institutions, and emergency information provided to medical institutions per subject was calculated. Estimate the 95% confidence interval.	—

Secondary

Measure	Time frame
1.Calculation of the average number of prescription changes, number of unscheduled consultations, treatment interruptions or hospitalizations per subject, and estimation of 95% confidence interval. 2.Descriptive statistical summary of information obtained from after-sales follow-up. 3.Calculation of average medication instruction time at the second visit and estimation of 95% confidence interval. 4.Calculation of average value of pharmacist reliability pre- and post-difference per subject and estimation of 95% confidence interval.	—

Measure

Time frame

1.Calculation of the average number of prescription changes, number of unscheduled consultations, treatment interruptions or hospitalizations per subject, and estimation of 95% confidence interval. 2.Descriptive statistical summary of information obtained from after-sales follow-up. 3.Calculation of average medication instruction time at the second visit and estimation of 95% confidence interval. 4.Calculation of average value of pharmacist reliability pre- and post-difference per subject and estimation of 95% confidence interval.

—

Countries

Japan

Contacts

Public ContactEiji Shimanuki

Qol Co., Ltd. Qol Academy, Education and Training Headquarters

e-shimanuki@qol-net.co.jp03-6430-9058

Outcome results