UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042857
Receipt number R000048921
Scientific Title Multicenter retrospective observational study on feasibility and preliminary effectiveness of psychological support program for AYA generation cancer patients
Date of disclosure of the study information 2020/12/25
Last modified on 2023/09/08 16:42:01

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Basic information

Public title

Multicenter retrospective observational study on feasibility and preliminary effectiveness of psychological support program for AYA generation cancer patients

Acronym

Multicenter retrospective observational study of psychological support program for AYA generation cancer patients

Scientific Title

Multicenter retrospective observational study on feasibility and preliminary effectiveness of psychological support program for AYA generation cancer patients

Scientific Title:Acronym

Multicenter retrospective observational study of psychological support program for AYA generation cancer patients

Region

Japan


Condition

Condition

AYA generation cancer patients

Classification by specialty

Medicine in general Psychosomatic Internal Medicine Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine feasibility and preliminary effectiveness of the psychological support program by conducting retrospective observational studies at multiple institutions that carry out psychological support programs for AYA generation cancer patients under clinical setting.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Screening rate

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

39 years-old >=

Gender

Male and Female

Key inclusion criteria

AYA generation cancer patients

Key exclusion criteria

non-AYA generation cancer patients

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Maiko
Middle name
Last name Fujimori

Organization

National Cancer Center, Japan

Division name

Division of Health Care Research, Behavioral Science and Survivorship Research Group, Center for Public Health Sciences

Zip code

1040045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan

TEL

03-3542-2511

Email

mfujimor@ncc.go.jp


Public contact

Name of contact person

1st name Takatoshi
Middle name
Last name Hirayama

Organization

National Cancer Center Hospital, Japan

Division name

Department of Psycho-Oncology

Zip code

1040045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan

TEL

03-3542-2511

Homepage URL


Email

thirayam@ncc.go.jp


Sponsor or person

Institute

National Cancer Center, Japan

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of National Cancer Center, Japan

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 25 Day


Related information

URL releasing protocol

https://doi.org/10.1007/s00520-023-07596-8

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s00520-023-07596-8

Number of participants that the trial has enrolled

361

Results

The number of cases at each facility was 138 at the NCCH, 86 at the SCC, 19 at the ACC, 50 at the NCUH, 19 at the NMC, 31 at St. Luke's International Hospital, 11 at the SCMC, and 7 at the NCCHD, for a total of 361 cases. The rates of the first screening was 90.3% (326/361)and the rates of the second screening was 50%(179/361).

Results date posted

2022 Year 06 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Participants' demographic characteristics were as follows. Two hundred six males and 155 females with an average age of 28.2 years were included. Three hundred four subjects (84.2%) were inpatients. The most common cancer type was bone and soft tissue cancer (n=131, 36.3%), followed by breast cancer (n=39, 10.8%). The most common stage at diagnosis was stage 4(n=91, 25.2%), followed by recurrence (n=45, 12.5%). The most common treatment setting was curative (n=193, 53.5%).

Participant flow

The sample size was pre-set to 200 patients (NCCH 100, NCUH 10, SCC 20, St. Luke's International Hospital 20, NMC 10, ACC 20, SCMS 10, and NCCHD 10). This was based on the average numbers of patients at the targeted departments of the 8 research institutions over the previous 3 years, and under the assumption that about 20% of the patients would drop out.

Adverse events

none

Outcome measures

Both the DT score and the number of checked items on the problem list were significantly lower after the support program, both among all patients (including those who missed the second screening; p<0.05) and among patients who completed both the first and second screenings (p<0.05). There was a mean of 18.6 days (SD 17) between the first and second screenings.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 07 Month 28 Day

Date of IRB

2020 Year 07 Month 28 Day

Anticipated trial start date

2020 Year 07 Month 31 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 12 Month 27 Day

Date trial data considered complete

2022 Year 01 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information

Research Institutes:
National Cancer Center Hospital, Japan
Nagoya City University Hospital
Nagoya medical Center
Shizuoka Cancer Center
Aichi Cancer Center
St Luke`s International Hospital
Saitama Children`s Medical Center
National Center for Child Health and Development


Management information

Registered date

2020 Year 12 Month 25 Day

Last modified on

2023 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048921


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name