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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name