UMIN-CTR Clinical Trial

Public title

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

Acronym

FORECAST study

Scientific Title

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

Scientific Title:Acronym

FORECAST study

Region

Japan

Condition

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

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Hematology and clinical oncology
Gastrointestinal surgery	Hepato-biliary-pancreatic surgery	Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In this study, symptom-related adverse events experienced by cancer patients visiting a pharmacy while taking oral anticancer drugs will be collected electronically using PRO-CTCAE, a Patient-Reported Outcome (PRO).
The primary objective is to determine the occurrence of symptom-related adverse events during the observation period (from the start of medication until the 12-week point).
The secondary objectives are to determine the rate and details of patient follow-up by pharmacy pharmacists during the observation period and to examine the association between follow-up and symptom-related adverse events, adherence, and satisfaction. In addition, depending on the availability of electronic PRO (ePRO) input, the follow-up group will be divided into two groups, the ePRO follow-up group and the usual follow-up group, to examine differences in the rate of follow-up, adherence and satisfaction.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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

Target sample size

77

Name of lead principal investigator

1st name	Ryohei
Middle name
Last name	Soeishi

Organization

Hachioji Pharmaceutical Center

Division name

Pharmacy

Zip code

193-0944

Address

1097, Tatemachi, Hachioji-city, Tokyo 193-0944 Japan

TEL

042-666-0931

Email

ryohei-soeishi@pharma802.com

Name of contact person

1st name	Hiroyuki
Middle name
Last name	Oakada

Organization

Hachioji Pharmaceutical Center Pharmacy

Division name

Pharmacy

Zip code

193-0944

Address

1097, Tatemachi, Hachioji-city, Tokyo 193-0944 Japan

TEL

042-666-0931

Homepage URL

Email

kaisyaizo@gmail.com

Institute

Hachioji Pharmaceutical Center Pharmacy

Institute

Department

Personal name

Organization

ealth Labour Sciences Research Grant Research on Policy Planning and Evaluation

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Tohoku University
Tokyo University of Pharmacy and Life Sciences
Tokyo University of Pharmacy and Life Sciences Pharmacy

Name of secondary funder(s)

Organization

Tokyo Pharmaceutical Association

Address

1-21, Kanda Nishiki-cho, Chiyoda-ku, Tokyo 101-0054 Japan

Tel

03-3294-0271

Email

druginfo@toyaku.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

八王子薬剤センター薬局（東京都）、東京薬科大学附属薬局（東京都）

Date of disclosure of the study information

2021

Year

11

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2021

Year

07

Month

07

Day

Date of IRB

2021

Year

11

Month

09

Day

Anticipated trial start date

2021

Year

11

Month

25

Day

Last follow-up date

2023

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center observational study to introduce adverse event assessment by ePRO into patient follow-up by pharmacists. Cancer patients taking oral anticancer drugs will be surveyed weekly for adverse events by ePRO from the baseline medication initiation to 12 weeks. This will be the ePRO follow-up group. If ePRO cannot be introduced to the subject, the usual follow-up will be conducted after investigating the reason. ePRO follow-up group and usual follow-up group will be surveyed for adherence and satisfaction, which will be conducted using paper media in the usual follow-up group. Patient follow-up will be conducted as a routine medical treatment and dispensing of medication, medication guidance, and pharmacological management guidance will also be conducted as routine medical treatment.

Registered date

2021

Year

11

Month

25

Day

Last modified on

2022

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051671