UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022857 |
|---|---|
| Receipt number | R000025330 |
| Scientific Title | Effectiveness of smartphone problem-solving therapy for fear of recurrence among breast cancer patients(Pilot Study) |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2017/11/05 16:00:50 |
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Basic information
Public title
Effectiveness of smartphone problem-solving therapy for fear of recurrence among breast cancer patients(Pilot Study)
Acronym
Problem-solving therapy for breast cancer patients
Scientific Title
Effectiveness of smartphone problem-solving therapy for fear of recurrence among breast cancer patients(Pilot Study)
Scientific Title:Acronym
Problem-solving therapy for breast cancer patients
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine preliminarily the effectiveness of smartphone problem-solving therapy for fear of recurrence among breast cancer patients
Basic objectives2
Others
Basic objectives -Others
To probe preliminarily the feasibility of smartphone problem-solving therapy for breast cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concerns About Recurrence Scale (CARS)
Key secondary outcomes
Hospital Anxiety and Depression Scale (HADS),EQ5D,FACIT-Sp-12,Short-form Supportive Care Needs Survey (SCNS-SF34),Social Problem-Solving Inventory-Revised(SPSI-R),Treatment satisfaction
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
Smartphone problem-solving therapy
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1)Patients with a diagnosis of invasive breast cancer(breast ductal carcinoma)
2)Patients who were disease-free survivors from 6 months after mastectomy or partial mastectomy
3)Patients whose performance status is 0-2
4)Patients who are smartfone users
5)Patients who hope to participate in this study
6)Patients who will not be hospitalized to a hospital for more than one month
7)Patients who are able to cooperate with additional telephone interviews for missing datum
Key exclusion criteria
1)Patients with too severe physical condition
2)Patients with too severe psychiatric condition
3)Inability to read and write Japanese
4)Patients receiving psychiatric treatment
5)Patients considered by their oncologists as inappropriateness of participation
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuminobu Imai |
Organization
Nagoya city university graduate school of medical sciences
Division name
Department of psychiatry and cognitive-behavioral medicine
Zip code
Address
1 kawasumi,mizuho-cho,mizuho-ku,nagoya 467-8601
TEL
052-853-8271
bunshin0427@trad.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminobu Imai |
Organization
Nagoya city university graduate school of medical sciences
Division name
Department of psychiatry and cognitive-behavioral medicine
Zip code
Address
1 kawasumi,mizuho-cho,mizuho-ku,nagoya 467-8601
TEL
052-853-8271
Homepage URL
bunshin0427@trad.ocn.ne.jp
Sponsor or person
Institute
Nagoya city university consultation-liaison psychiatry team
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
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
| 2016 | Year | 06 | Month | 27 | 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
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
| 2016 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025330
