An Observational Study of Follow-up for Symptomatic Adverse Events Using ePRO in Gastrointestinal Cancer Patients after Starting Oral Anticancer Therapy in Pharmacy

An Observational Study of Follow-up for Symptomatic Adverse Events Using ePRO in Gastrointestinal Cancer Patients after Starting Oral Anticancer Therapy in Pharmacy - FORECAST study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046186

Enrollment

Registered

2021-11-25

Start date

2021-11-25

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

colon cancer, gastric cancer, pancreas cancer, biliary tract cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 20 years old or older 2. have been diagnosed with colorectal, gastric, pancreatic, or biliary tract cancer 3. Treatment with S-1 or capecitabine will be initiated 4. Patient's written consent for participation in the study has been obtained.

Exclusion criteria

Exclusion criteria: 1. Severe mental illness 2. have cognitive impairment that may affect their ability to complete the questionnaire 3. Native language is not Japanese

Design outcomes

Primary

Measure	Time frame
To estimate point estimates and 95% confidence intervals for the rate of the worst symptom-related adverse events at 12 weeks.	—

Secondary

Measure	Time frame
In the ePRO follow-up group, 1. To estimate the point estimate and 95% confidence interval of the rate of symptom-related adverse events at each time point of weeks 1-12 2. To estimate the rate of PRO-CTCAE input, the rate of PRO-CTCAE input results viewed, and the rate of follow-up at each time point of week 1-12, and for 12 weeks (week 1-12) 3. To examine the relationship between the rate of PRO-CTCAE input at 12 weeks (week 1-12) and the ASK-12, CTSQ scores, and MPR In the ePRO follow-up group and the usual follow-up group, 1. To compare the follow-up rate at each time point of week 1-12 and the rate for 12 weeks (week 1-12) 2. To compare the number of tracing reports for 12 weeks (week 1-12) 3. To compare ASK-12 and CTSQ scores and MPR 4. To examine the relationship between the rate of 12-week (week 1-12) follow-up and ASK-12, CTSQ scores, and MPR 5. To summarize follow-up details as descriptive statistics	—

Measure

Time frame

In the ePRO follow-up group, 1. To estimate the point estimate and 95% confidence interval of the rate of symptom-related adverse events at each time point of weeks 1-12 2. To estimate the rate of PRO-CTCAE input, the rate of PRO-CTCAE input results viewed, and the rate of follow-up at each time point of week 1-12, and for 12 weeks (week 1-12) 3. To examine the relationship between the rate of PRO-CTCAE input at 12 weeks (week 1-12) and the ASK-12, CTSQ scores, and MPR In the ePRO follow-up group and the usual follow-up group, 1. To compare the follow-up rate at each time point of week 1-12 and the rate for 12 weeks (week 1-12) 2. To compare the number of tracing reports for 12 weeks (week 1-12) 3. To compare ASK-12 and CTSQ scores and MPR 4. To examine the relationship between the rate of 12-week (week 1-12) follow-up and ASK-12, CTSQ scores, and MPR 5. To summarize follow-up details as descriptive statistics

—

Countries

Japan

Contacts

Public ContactHiroyuki Oakada

Hachioji Pharmaceutical Center Pharmacy Pharmacy

kaisyaizo@gmail.com042-666-0931

Outcome results