A Cohort Study of Supportive and Palliative Care for Patients and Families with Retinoblastoma

A Prospective Cohort Study of Comprehensive Supportive and Palliative Care for Patients and Families with Retinoblastoma - A Prospective Cohort Study of Comprehensive Supportive and Palliative Care for Patients and Families with Retinoblastoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054505

Enrollment

150

Registered

2024-05-30

Start date

2024-06-11

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

retinoblastoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who fulfill all of the following criteria are eligible for the study. 1) Patients with retinoblastoma and their family members within one month of diagnosis. 2) Age less than 5 years at the time of diagnosis. 3) The patient must be visiting or being admitted to a research institution participating in this clinical study. 4) Written consent is obtained. 5) Consent, including secondary use of information, is obtained in the 'Retinoblastoma National Registry' study.

Exclusion criteria

Exclusion criteria: Subjects who fulfil any of the following criteria will be excluded from the study 1) Extraocular recurrence cases. 2) Cases with obvious extraocular lesions or distant metastases, as evidenced by symptoms, imaging studies, etc. 3) Cases of second primary malignancies (including third and subsequent malignancies). 4) Other participants deemed inappropriate by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Whether the RB-ePRO assessment has been continued for 6 months (more than or equal to 70% continuation) RB-ePRO continuation is considered to be present if the third (6 months later) assessment with the Anxiety, Depression and Recurrence Concerns measurement scale (GAD-7, PHQ-9, FCRI-P) has been conducted. Generalised Anxiety Disorder-7 (GAD-7): Generalised Anxiety Scale (Japanese version) Patient Health Questionnaire (PHQ-9): Depression and Troubled Feelings Rating Scale (Japanese version) Fear of Cancer Recurrence Inventory-Parent version (FCRI-P): recurrence concern scale.	—

Measure

Time frame

Whether the RB-ePRO assessment has been continued for 6 months (more than or equal to 70% continuation) RB-ePRO continuation is considered to be present if the third (6 months later) assessment with the Anxiety, Depression and Recurrence Concerns measurement scale (GAD-7, PHQ-9, FCRI-P) has been conducted. Generalised Anxiety Disorder-7 (GAD-7): Generalised Anxiety Scale (Japanese version) Patient Health Questionnaire (PHQ-9): Depression and Troubled Feelings Rating Scale (Japanese version) Fear of Cancer Recurrence Inventory-Parent version (FCRI-P): recurrence concern scale.

—

Secondary

Measure	Time frame
Anxiety, depression and concern about recurrence among family members of patients after retinoblastoma diagnosis Analysis of factors influencing anxiety, depression and concern about recurrence after retinoblastoma diagnosis Identification of needs related to prosthetic eye Percentage of RB1 genetic testing performed Financial burden not covered by health insurance, etc.	—

Countries

Japan

Contacts

Public ContactHiroyoshi Hattori

National Hospital Organization Nagoya Medical Center Department of Clinical Genetics

hiroyoshi.hattori@nnh.go.jp052-951-1111

Outcome results