UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062823 |
|---|---|
| Receipt number | R000066184 |
| Scientific Title | A Multicenter Randomized Controlled Trial to Evaluate the Effectiveness of a Decision Support Program for Patients with Hematological Malignancies Using a Prompt List of Questions and Coaching; MagiQ Study |
| Date of disclosure of the study information | 2026/09/08 |
| Last modified on | 2026/09/08 08:48:59 |
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Basic information
Public title
A Study to Evaluate the Effectiveness of a Decision Support Program Using a Question Prompt List and Nurse-led Navigation for Patients with Hematological Malignancies (MagiQ Study)
Acronym
MagiQ Study
Scientific Title
A Multicenter Randomized Controlled Trial to Evaluate the Effectiveness of a Decision Support Program for Patients with Hematological Malignancies Using a Prompt List of Questions and Coaching; MagiQ Study
Scientific Title:Acronym
MagiQ Study
Region
| Japan |
Condition
Condition
Adult patients newly diagnosed with diffuse large B-cell lymphoma, follicular lymphoma, multiple myeloma, or myelodysplastic syndrome who are scheduled to receive first-line treatment
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether a decision support program combining a Question Prompt List(QPL) with nurse-led navigation improves patients' satisfaction with decision support compared with usual care among patients with hematological malignancies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
After consultation with the physician: Patients Satisfaction Questionnaire: PSQ
Key secondary outcomes
1. Preparation for decision making: Assessed after the physician consultation using the Japanese version of the Preparation for Decision Making Scale (J-PrepDM).
2. Level of anxiety: Assessed before randomization and after the physician consultation using the Generalized Anxiety Disorder-7 (GAD-7).
3. Number of questions asked by the patient: Assessed as the number of questions asked by the patient during the physician consultation.
4. Consultation duration: Measured from the beginning to the end of the physician consultation.
5. Acceptability of the intervention: Assessed among participants in the intervention group after the physician consultation in terms of the usefulness of the QPL and nurse-led navigation, ease of asking questions, willingness to use the intervention again, and appropriateness of its timing.
6. Qualitative data: A subset of participants in the intervention group will be contacted within two weeks after the intervention to arrange a semi-structured interview. The interview will qualitatively explore their experiences with the decision support program, its helpful aspects, and areas requiring improvement.
7. Appropriateness, acceptability, and feasibility for implementation: Physicians and nurses participating in the study will evaluate the appropriateness, acceptability, and feasibility of implementing the decision support program in clinical practice using a questionnaire and free-text responses after completion of the study.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
In addition to receiving the common booklet, participants will receive a single session of a decision support program consisting of nurse-led navigation using a Question Prompt List (QPL) for patients with hematological malignancies before the physician consultation.
Interventions/Control_2
Participants will receive usual care, including the common booklet provided to both groups.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are able to communicate in Japanese.
2. Patients who have received a sufficient explanation of the study, fully understood its content, and provided written informed consent to participate of their own free will.
Key exclusion criteria
1. Patients with a history of chemotherapy or radiotherapy.
2. Patients whom a physician judges to be unable to participate in the study because of a marked decline in physical functioning or severe distress.
3. Patients with a serious psychiatric disorder or dementia.
Target sample size
292
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Shirai |
Organization
Kansai Medical University
Division name
Faculty of Nursing and Graduate School of Nursing
Zip code
573-1004
Address
2-2-2 Shin-machi, Hirakata City, Osaka-fu
TEL
072-804-0148
shirai.yuk@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Miharu |
| Middle name | |
| Last name | Morikawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Oncology Nursing and Palliative Care, Human Health Sciences
Zip code
606-8507
Address
53 ShogoinKawaramachi, Sakyo-ku, Kyoto-shi, Kyoto-fu
TEL
080-6205-3266
Homepage URL
https://saqra.jp/studies/study/qbvw6ht5ni
magiqstudy@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Yuki Shirai
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Supporting Center for Clinical Research and Education (SaQRA)
Graduate School of Medicine, Kyoto University
National Cancer Center Japan
The Jikei University School of Medicine
Shizuoka Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1Shin-machi, Hirakata City, Osaka-fu
Tel
072-804-0101
rinriirb@kmu.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
関西医科大学附属病院（大阪府）、社会医療法人北楡会 札幌北楡病院（北海道）、医療法人 菊郷会 愛育病院（北海道）、岩手県立中央病院（岩手県）、東京慈恵会医科大学附属柏病院（千葉県）、東京慈恵会医科大学附属病院（東京都）、日本赤十字社 京都第二赤十字病院（京都府）、日本赤十字社大阪赤十字病院（大阪府）、近畿大学奈良病院（奈良県）、佐世保市総合医療センター（長崎県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066184
