Poster Presentation 2025 Joint Meeting of the COSA ASM and IPOS Congress

A Study of MagiQ(Hematologic Informed Decision Support Using a Question Prompt List and Coaching) Program for Patients with Hematological Malignancies ：Protocol for a multi-center randomized controlled trial(RCT) (125708)

Miharu Morikawa 1 2 , Maiko Fujimori 3 , Junya Kanda 4 , Keita Mori 5 , Junya Makiyama 6 , Yousuke Uchitomi 7 , Yuki Shirai 1 2
  1. Palliative Nursing, Course of Advanced Nursing Sciences, Department of Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  2. Faculty of Nursing and Graduate School of Nursing, Kansai Medical University, Hirakata, Osaka, Japan
  3. Division of Survivorship Research, National Cancer Center Institute for Cancer Control, Chuo-ku, Tokyo, Japan
  4. Department of Hematology, Kyoto University Hospital, Kyoto, Japan
  5. Clinical Research Center, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
  6. Department of Hematology, Sasebo City General Hospital, Sasebo, Nagasaki, Japan
  7. Department of Cancer Survivorship and Digital Medicine, The Jikei University School of Medicine,, Minato-ku, Tokyo, Japan

Background/rationale: Patients with hematologic malignancies are confronted with complex clinical features and high-risk treatment decisions, yet lack tailored, implementable decision-support programs. This abstract introduces the protocol for a multicenter randomized controlled trial (RCT) evaluating a decision support program combining a Question Prompt List (QPL) and coaching for patients with hematologic malignancies.

Methods: This study is an open-label, multicenter RCT across six Japanese facilities. The study subjects are patients with hematologic malignancies (diffuse large B-cell lymphoma, follicular lymphoma, myelodysplastic neoplasms, or multiple myeloma) scheduled for initial inpatient treatment. Participants will be recruited and randomized using the minimization method through a secure, validated system. Based on previous studies, the sample size is 292 participants. Control-group participants will receive the facility’s standard informational brochure; intervention-group participants will receive the standard brochure plus a tailored QPL for hematologic malignancies, and nurse-led coaching before their physician consultation. Outcomes are assessed by a post-consultation questionnaire. The primary outcome is the Patient Satisfaction Scale, which evaluates patients' satisfaction with their physicians' decision-making in the two groups. Secondary outcome measures include the usefulness of decision support for decision-making preparedness, using the Preparation for Decision Making Scale; decision-making conflict, using the SURE test; anxiety, using the Generalized Anxiety Disorder-7; number of questions asked; and consultation duration. After approval from the Ethics Committee of Kansai Medical University, this study will commence and conclude in March 2027.

Impact on practice: If effective, this intervention may help patients to organize concerns before consultations and communicate them accurately to healthcare providers, fostering interactive communication. It may also encourage patients to actively participate in treatment, alleviate anxiety, and enhance their quality of life.

Discussion: The intervention used in this study (nurses encouraging patients to express their concerns using the QPL) is considered to be an approach that is easy to implement in clinical practice.