UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042175 |
|---|---|
| Receipt number | R000048135 |
| Scientific Title | Development of a self-help program focusing on change in functioning for cancer survivors: A pilot study |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2021/04/20 10:56:26 |
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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)
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
koto.h711@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048135
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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