UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018900 |
|---|---|
| Receipt number | R000021874 |
| Scientific Title | Efficacy of Stress Management Program for Depressive Patients with Advanced Head and Neck Cancer: an open-label randomized controlled trial |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2023/06/29 09:12:35 |
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Basic information
Public title
Efficacy of Stress Management Program for Depressive Patients with Advanced Head and Neck Cancer: an open-label randomized controlled trial
Acronym
Stress Management Program for Patients with Advanced Head and Neck Cancer (SMAP-HNC study)
Scientific Title
Efficacy of Stress Management Program for Depressive Patients with Advanced Head and Neck Cancer: an open-label randomized controlled trial
Scientific Title:Acronym
Stress Management Program for Patients with Advanced Head and Neck Cancer (SMAP-HNC study)
Region
| Japan |
Condition
Condition
Patients with advanced head and neck cancer after initial curative treatment
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the efficacy of stress management program for depressive patients with advanced head and neck cancer using an open-label randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in total score of Hospital Anxiety and Depression Scale (HADS) from the time of hospital discharge to the first outpatient visit
Key secondary outcomes
Change in total score of HADS from the time of hospital discharge to the 3 months after the intervention
Change in each factor's score of HADS
Change in each factor's score of Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N)
Change in each factor's score of Head and Neck Cancer Inventory (HNCI)
Change in each factor's score of Brief Coping Inventory (COPE)
Change in total score of The Athens Insomnia Scale (AIS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention:
The program, which was based a problem solving training for head and neck cancer patients and stress coping training for HIV patients, was developed by three clinical psychologists, a psychiatrist, three otorhinolaryngologists, and a nurse. We named this program as "Stress Management Program for Patients with Advanced Head and Neck Cancer (SMAP-HNC)". SMAP-HNC is conducted by clinical psychologist with a master degree. The session takes 90 minutes at the time of hospital discharge and the follow-up session takes 30 minutes at the first outpatient visit. The main purpose of the SMAP-HNC is to (1) enhance the knowledge of stress coping skill and (2) expand repertoire of stress coping skill. The themes of the sessions are: (a) psychoeducation about head and neck cancer and stress, (b) present stressor for the patients, (c) goal setting, (d) recording achievement rate of the goal, and (e) evaluation of the stress coping skill as the goal. Supportive psychotherapy is used in a variety of clinical context. All patients are treated with usual care as a controlled group.
Interventions/Control_2
Control:
All patients are treated with usual care by physicians, nurses, and other medical providers.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Who has larynx, epipharynx, oropharynx, hypopharynx, and/or oral cancer
(2)Who has a diagnosis of squamous cell cancer (SCC)
(3)Who has stage III or IV cancer
(4)Who is admitted patient after initial radiation or operation therapy
(5)Who is over 20 years old and under 80 years old
(6)Who has depression (HADS total score >=11)
Key exclusion criteria
Who cannot participate the intervention or answer the questionnaire because of his/her physical, mental, or cognitive function.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eisuke Matsushima |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Section of Liaison Psychiatry and Palliative Medicine
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5859
em.lppm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanako Ichikura |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Department of Psychosomatic and Palliative Medicine
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5859
Homepage URL
ichikura-creha@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Section of Head and Neck Surgery, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Department of Head and Neck Surgery, Medical Hospital, Tokyo Medical and Dental University
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
東京医科歯科大学医学部附属病院（東京都）／Medical Hospital, Tokyo Medical and Dental University (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 02 | 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
| 2015 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021874
