UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022141 |
|---|---|
| Receipt number | R000025519 |
| Scientific Title | Stress properties of the patients with Hematologic Malignancies. -Effect of cognitive-behavioral therapy program combines exercise therapy on autonomic nerve function- |
| Date of disclosure of the study information | 2016/04/29 |
| Last modified on | 2021/05/06 19:03:33 |
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Basic information
Public title
Stress properties of the patients with Hematologic Malignancies.
-Effect of cognitive-behavioral therapy program combines exercise therapy on autonomic nerve function-
Acronym
An intervention study to stress attenuation and enhancement of locomotor activity in patients with Hematologic Malignancies.
Scientific Title
Stress properties of the patients with Hematologic Malignancies.
-Effect of cognitive-behavioral therapy program combines exercise therapy on autonomic nerve function-
Scientific Title:Acronym
An intervention study to stress attenuation and enhancement of locomotor activity in patients with Hematologic Malignancies.
Region
| Japan |
Condition
Condition
hematologic malignancy
Classification by specialty
| Hematology and clinical oncology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the intervention combined with exercise and the attention bias modification method based on cognitive behavioral therapy, that give to attenuate the symptomatic anxiety and the gain in an amount of locomotor activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States
Key secondary outcomes
Autonomic nervous system
Salivary amylase activity
Locomotor activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise therapy
Attention bias modification (ABM)
Cognitive behavioral therapy
Interventions/Control_2
Exercise therapy
Placebo ABM
Stretching
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
| 18 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) The patients with leukemia and malignant lymphoma who scheduled for chemotherapy or hematopoietic stem cell transplantation, they has been prescribed occupational therapy after the announcement by doctor past two weeks.
(2) Any person can be more than 40 minutes sitting at a position holds.
Key exclusion criteria
(1) merging the central disease
(2) depression and history of mental disorders of anxiety
(3) the cognitive decline admit persons
(4) a person who has exhibited serious side effects on the autonomic nervous with chemotherapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Koizumi |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4367
izumiko@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | koizumi |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4367
Homepage URL
izumiko@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
Tel
042-984-4367
izumiko@saitama-med.ac.jp
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 | 04 | Month | 29 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jadr.2021.100122
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jadr.2021.100122
Number of participants that the trial has enrolled
30
Results
Differences between treatment and control groups: primary outcome (psychological index)
Regarding the POMS tension-anxiety score, there was an interaction effect between the intervention group and time, and an association between tension-anxiety scores and time. A simple main effects analysis revealed that post-treatment anxiety was significantly lower in the treatment group than in the control group.
Results date posted
| 2021 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty patients completed the study. The subjects included 10 women and 20 men. The cancer diagnoses included non-Hodgkin's lymphoma, leukemia, myelodysplastic syndrome, and multiple myeloma. There were no significant differences in demographics or baseline physical characteristics between the groups.
Participant flow
Patients were assigned to either the treatment or control group, with matching to ensure an equal distribution of sex, age, and cancer type between the two groups. All patients were blinded to group assignments. Of the 32 patients, two dropped out as they were discharged during the study period.
Adverse events
During the intervention period, there were no significant adverse events (CTCAE: Grade under1), no changes in performance status, and no strong side effects of chemotherapy.
Outcome measures
In this study, the anxiety mood of the cancer patients was measured rather than the acute stress response. The anxiety, referred to in this study, was measured by POMS (tension-anxiety) and does not include trait anxiety or anxiety disorders. The POMS measurement was used to assess the past week of anxiety within the 4-week study period.
The secondary outcome measures were heart rate variability (HRV) and the number of steps taken daily.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025519
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