UMIN-CTR Clinical Trial

Public title

Efficacy of intervention program based on cognitive behavior therapy for cancer patients

Acronym

Intervention program based on cognitive behaior therapy for cancer patients

Scientific Title

Efficacy of intervention program based on cognitive behavior therapy for cancer patients

Scientific Title:Acronym

Intervention program based on cognitive behaior therapy for cancer patients

Region

Japan

Condition

Breast cancer

Classification by specialty

Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Purpose of this study is to exmanine whether psychological intervention that was based on the problem-solving treatment is feasible or not, and to clearfy if the psychological distress decreases more than a usual, natural decrease for the breast cancer patient who completed the adjuvant chemotherapy after the operation and had psychological pain compared with before intervention

Basic objectives2

Others

Basic objectives -Others

Feasibility/ Usability

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Japanese version of Hospital Anxiety and Depression Scale(HADS)

Key secondary outcomes

1. Japanese version of Hospital Anxiety and Depression Scale(HADS)
2. EORTC-QLQ-C30
3.Brief Cancer-related Worry Inventory
4. The short-form Supportive Care Needs Survey(SCNS-SF34)
5. Self-efficacy Scale for advanced cancer
6. Mental adjustment to Cancer Scale (MAC)
7. The Concerns About Recurrence Scale (CARS)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Female

Key inclusion criteria

1. Patients diagnosed as breast cancer clinically, histologically, or pathologically
2. Patients who has received the adjuvant chemotherapy or the adjuvant hormon therapy after operation or who has received the neo-adjuvant chemotherapy before operation
3. Patients who has explained about their diagonosis
4. Age older than 20 years and younger 70 years
5. ECOG PS was 0 or 1, and has abillity to go to the hospital and to do slightl physical activity
6. Patients who has met with following criterion based on "Distress and Impact Thermometer": Distress score was above 3 and Impact score was above 1.

Key exclusion criteria

1. Patients diagnosed that the psychiatric treatment will be necessary by phsician, such as depressive disorder with suicidal thoughts or wishes.
2. Patients with evidence of cognitive impairment such as dementia and delirium or mental illness such as schizophrenia
3. Patients who take parmacotherapy by antipsychotics
4. Patients with evidence of cognitive function impairment
5. Patients with difficulty literacy of Japanese

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kei Hirai

Organization

Graduate School of Medicine, Faculty of Medicine

Division name

Department of Complementalry and Alternative Medicine

Zip code

Address

Yamadaoka 2-2, Suita City, 565-0871, JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name	Kei Hirai

Organization

Graduate School of Medicine, Faculty of Medicine

Division name

Department of Complementalry and Alternative Medicine

Zip code

Address

Yamadaoka 2-2, Suita City, 565-0871, JAPAN

TEL

Homepage URL

Email

Institute

Osaka University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

07

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2008

Year

06

Month

26

Day

Date of IRB

Anticipated trial start date

2008

Year

08

Month

01

Day

Last follow-up date

2011

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

06

Month

26

Day

Last modified on

2011

Year

12

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001480