UMIN-CTR Clinical Trial

Basic information
Public title	The development and the effect of a self-help program focusing on functional change in activity for cancer survivors: A pilot study
Acronym	A pilot study of a self-help program for cancer survivors
Scientific Title	Development of a self-help program focusing on change in functioning for cancer survivors: A pilot study
Scientific Title:Acronym	A pilot study of a self-help program focusing on change in functioning for cancer survivors
Region	Japan

Condition
Condition	Depressive disorders
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To conduct a preliminary study to examine the effect of a self-help program booklet, which aimed to improve activity restriction and to promote reward perception, on psychological adjustment in cancer survivors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological adjustment: Hospital Anxiety and Depression Scale (HADS),Benefit Finding Scale
Key secondary outcomes	Activity Restriction: Sickness Impact Scale for Cancer Patients (SIP-C-R) Effortful Relieving Behaviors for Anxiety and worries related to cancer recurrence and progression: Effortful Relieving Behaviors for Anxiety and worries related to Cancer (ERBA-C) Environmental Reward Perception: Environmental Reward Observation Scale (EROS)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Self-help program focusing on functional change: a total of 4 weeks, 5 sessions in total. Each week, participants will read a psycho-education textbook, keep a daily activity log, and will participate in a 30-minute review meeting with the interventionist is conducted via videoconference or telephone (question-and-answer session and task explanation).
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Diagnosed with cancer 2. Is told that they are diagnosed with cancer 3. Ages 20 to 89 years
Key exclusion criteria	1. Has difficulties in reading and writing Japanese 2. Is diagnosed with mental illness 3. Is receiving some kind of medication or counseling for mental health issues. 4. Has difficulties in carrying out the program due to mental condition
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Shin-ichi Middle name Last name Suzuki
Organization	Waseda University, Faculty of Human Science
Division name	Clinical Psychology Research
Zip code	359-1192
Address	Mikajima,Tokorozawa, Saitama
TEL	04-2949-8113(8320)
Email	ssuzuki@waseda.jp

Public contact
Name of contact person	1st name Kotone Middle name Last name Hata
Organization	Waseda University, Department of Human Science
Division name	Clinical Psychology Research
Zip code	359-1192
Address	Mikajima, Tokorozawa, Saitama
TEL	04-2949-8113(8320)
Homepage URL
Email	koto.h711@akane.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	MEXT(Japan)
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	Waseda University
Address	1-104 Totsuka, Shinjuku, Tokyo
Tel	03-5272-1639
Email	rinri@list.waseda.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 10 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 10 Month 08 Day
Date of IRB	2020 Year 10 Month 08 Day
Anticipated trial start date	2020 Year 10 Month 19 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 19 Day
Last modified on	2021 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048135