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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010913
Receipt No. R000012715
Scientific Title Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Date of disclosure of the study information 2013/06/10
Last modified on 2016/08/17

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Basic information
Public title Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Acronym Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Scientific Title Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Scientific Title:Acronym Supportive care needs in advanced cancer patients receiving rehabilitation interventions.
Region
Japan

Condition
Condition cancer
Classification by specialty
Hematology and clinical oncology Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the prevalence of the unmet needs among advanced cancer patients and the relation between the unmet needs and distress/activities of daily living.
Basic objectives2 Others
Basic objectives -Others To assess the prevalence of the unmet needs among advanced cancer patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the prevalence of the unmet needs among cancer patients and the relation between the unmet needs and distress/activities of daily living.
Key secondary outcomes satisfaction with rehabilitation.
usefulness of rehabilitation for emotional support.
the prevalence of psychological distress.
the prevalence of symptoms.
the relation between the satisfaction and the types of rehabilitation management/classification of cancer rehabilitation/activities of daily living/psychological distress.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria patients with a cancer diagnosis
an age of 20 years or older
well enough to complete the questionnaire
informed of the cancer diagnosis
cancer, thought to have a poor prognosis
participated in a physical examination 5 times or more
Key exclusion criteria severe mental or cogniitive disorder
an inability to understand the japanese language
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hasegawa Takaaki
Organization Gifu municipal hospital
Division name Department of respiratory and medical oncology
Zip code
Address 7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Gifu municipal hospital
Division name Department of respiratory and medical oncology
Zip code
Address 7-1 KASHIMA-CHO GIFU-SHI GIFU
TEL
Homepage URL
Email

Sponsor
Institute Gifu municipal hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 06 Month 10 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 Main results already published
Date of protocol fixation
2013 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We use multiple logistic regression to investigate the relation between the unmet needs and HADS score/FIM, and the relation between the satisfasction or usefulness of rehabilitation for emotional support and HADS score/FIM/unmet needs.

Management information
Registered date
2013 Year 06 Month 09 Day
Last modified on
2016 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012715

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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