Development of a Mindfulness-Based Stress Reduction Program for Hematologic Malignancy Patients: A Delphi Study

Introduction

Hematologic malignancy (HM) encompasses a group of malignant clonal diseases originating from the bone marrow, lymphatic tissues, and blood, including specific subtypes such as leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia), lymphoma (Hodgkin lymphoma, non-Hodgkin lymphoma), myelodysplastic syndromes, and multiple myeloma, all confirmed by bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) or pathological examination.¹ These diseases are characterized by a high degree of malignancy and rapid progression and pose significant treatment challenges, severely diminishing patient survival and quality of life.² Statistical studies indicate that approximately 918,000 are diagnosed with HM worldwide annually.³

The etiology of HM is complex, potentially involving genetic mutations, environmental exposures, and immune dysregulation, among other factors.⁴ Treatment typically includes lengthy and arduous courses such as chemotherapy, radiation therapy, and bone marrow transplantation, imposing a heavy economic burden on patients and their families.⁵ Due to the uncertainty related to the disease and the side effects of treatment, patients often experience psychological issues such as anxiety and depression, as well as significant sleep disturbances, leading to a decline in quality of life.⁶

In the 1970s, Dr. Jon Kabat-Zinn introduced Mindfulness-Based Stress Reduction (MBSR) as the third wave of cognitive-behavioral therapy, and MBSR has proven to be an effective intervention for promoting mental health.⁷ MBSR cultivates mindfulness and acceptance of the present moment, helping individuals better cope with stress, emotions, and pain, thereby enhancing their psychological well-being.⁸ In addition to its widespread application in the management of mental health, MBSR has also been applied to help patients cope with various physiological discomforts caused by clinical diseases to achieve effects such as pain management and immune modulation, with significant results.⁹

However, despite the extensive international application and research of MBSR, its use in China is still in its infancy. Therefore, it is necessary to further explore the applicability, target population, and long-term effects of MBSR in China, particularly for special populations such as patients with HM. The present study was designed to enrich and refine the content of MBSR based on actual conditions of HM patients with the objectives of developing standardized methods tailored to this specific population and to explore the role and effectiveness of MBSR in improving patients’ psychological and physiological states. This research is expected to provide more effective psychological support and physiological adjustment for patients with HM, thereby enhancing their quality of life and treatment outcomes, and to offer new insights and methods for comprehensive treatment in China.

Materials and Methods

Research Team

Establishing a research team was a crucial step in ensuring the comprehensive and efficient implementation of this study. The team included professionals from multiple disciplines, including a Director of Nursing, a Department Director, a Head Nurse, a Deputy Chief Nurse, specialized nurses, and psychology experts. Individual members of the research team were assigned different responsibilities and roles, and worked closely together to advance the progress of the study.

The Director of Nursing played a central leadership role in the team and was responsible for overall planning and decision-making regarding the project, ensuring its smooth progress. Additionally, this person was in charge of selecting suitable expert members and conducting consultations to ensure the professionalism and scientific rigor of the study.

The Department Director and Head Nurse were responsible for specifically coordinating program implementation within the research. They organized and arranged the implementation of various activities, ensuring the smooth progress of the research process and coordinating solutions to potential problems and difficulties.

As a crucial member of the team, the Deputy Chief Nurse was responsible for the construction and design of the program. Drawing on extensive clinical experience and professional knowledge, this person formulated scientifically sound research plans tailored to the study’s objectives and requirements.

Specialized nurses were integral members of the research team, tasked with formulating, distributing, and collecting expert inquiry questionnaires. With their wealth of clinical experience and professional skills, they effectively carried out related tasks, providing strong support for the research.

Psychology experts were essential members of the research team, assisting in the development and implementation of MBSR therapy. With their extensive knowledge of psychology and clinical experience, they provided professional psychological support and guidance to patients, ensuring the smooth and effective implementation of the study.

Through the establishment of this multidisciplinary, closely coordinated research team, it was possible to fully leverage the professional strengths of each member, promote the smooth progress of the research work, ensure the scientific validity and reliability of the research results, and provide better psychological support and nursing services for patients with HM.

Construction of MBSR Therapy for HM Patients

Literature Review

A comprehensive literature review was conducted to search, compile, and analyze relevant studies on MBSR therapy conducted in China and around the world. This review served as a reference for developing the intervention protocol in this study. Utilizing search terms such as “Mindfulness” OR “MBSR” OR “Mindfulness-based stress reduction” AND “Randomized Controlled Trial” OR “Comparative Study” OR “Clinical trial”, searches were performed in English databases including Web of Science, PubMed, and MEDLINE. Additionally, the Chinese databases Wanfang Medical Online and China National Knowledge Infrastructure (CNKI) were searched using corresponding Chinese terms. The search period was limited from database inception to the present data.

The inclusion criteria for literature screening were as follows: 1) studies involving clinical patients; 2) primary intervention method of MBSR therapy; and 3) main outcome indicators including anxiety, depression, quality of life, and sleep disturbances. The exclusion criteria were: 1) full text not available; 2) duplicate publication; 3) violation of statistical analysis principles; and 4) data in the literature not applicable.

Through the literature search, a total of 102 relevant articles were initially retrieved, including 68 published in English and 34 published in Chinese. Two researchers independently screened the articles according to the inclusion and exclusion criteria. After the exclusion of 86 articles, 2 Chinese articles^10,11 and 10 English articles^12–22 were retained. A thorough review of these studies provided an understanding of the current status of patients with HM and the progress in related nursing research. Combined with clinical practical issues, a preliminary intervention protocol for MBSR therapy for HM patients was developed, including 3 primary indicators, 12 secondary indicators, and 31 tertiary indicators.

Mindfulness Therapy Protocol Development

Insights gained from the articles identified in the literature review were integrated with clinical expertise and practical considerations in the preliminary construction of MBSR therapy specifically tailored to patients with HM. Based on the findings from the literature review and considering the unique needs and challenges faced by patients with HM, key components of MBSR therapy were identified. These components encompassed mindfulness meditation techniques, cognitive-behavioral strategies, relaxation exercises, and psychoeducation. Given the distinctive characteristics of HM and their impact on patients’ physical and psychological well-being, adaptations were made to traditional MBSR techniques. These adaptations aimed to address specific symptoms and concerns commonly experienced by patients with HM, such as fatigue, pain, treatment-related anxiety, and emotional distress.

Building upon the identified key components and adaptations, an intervention protocol was formulated through collaboration among members of the research team, including nursing directors, clinical specialists, psychologists, and specialized nurses. Each member contributed their expertise to ensure the comprehensive and effective design of the MBSR therapy program. The intervention protocol detailed the structure, content, and delivery methods of MBSR therapy for patients with HM, specifying the sequence of sessions, duration of each session, specific mindfulness exercises, and strategies for addressing individual needs and preferences.

Before implementation of the intervention protocol, pilot testing was performed with a small group of patients to evaluate its feasibility, acceptability, and preliminary efficacy. Feedback from patients and healthcare providers was collected and used to refine the protocol, ensuring its relevance and effectiveness in the context of HM.

In summary, the preliminary construction of MBSR therapy for patients with HM was achieved by identifying key intervention components, adapting techniques for the specific population, developing an intervention protocol in collaboration with the research team, and refining the protocol through pilot testing. This process aimed to create a tailored and evidence-based intervention that addresses the unique needs of patients with HM and enhances their psychological well-being and quality of life.

Delphi Expert Consultation

Development of Expert Consultation Questionnaire

To apply the expert opinions effectively, a structured questionnaire was devised, building upon the insights gleaned from the literature review and the initial framework of MBSR therapy for patients with HM. The questionnaire contained three sections: 1) the Introduction, which provided a brief overview of the research plan and guidelines for completing the questionnaire to ensure clarity and consistency in responses; 2) the Main Questionnaire, which presented the expert opinion table on MBSR therapy for HM patients. Utilizing a Likert scale ranging from “extremely important” to “not important at all”, experts rated the importance of each indicator. Additionally, experts were asked to offer modifications and suggestions for each item to acquire comprehensive feedback. Furthermore, an item addition/deletion section was included, which allowed experts to propose additional indicators deemed relevant or to suggest removal of those deemed redundant; and 3) the Basic Information Survey, which gathered demographic data and aimed to ascertain the level of familiarity of experts with the consultation content, ensuring a diverse and well-informed expert panel.

Expert Selection Criteria

Stringent criteria were applied to ensure the selection of highly qualified experts: 1) Expertise: Specialization in hematologic oncology (clinical nursing, medical oncology), clinical psychology, or nursing psychology, with academic or clinical focus on psychosocial support for cancer patients. 2) Qualifications and Experience: Minimum educational background of a bachelor’s degree; professional title of intermediate or higher (eg, associate chief nurse, chief psychologist); and at least 10 years of full-time clinical or research experience in hematologic malignancies or mindfulness-based interventions. 3) Voluntary Participation: Confirmed willingness to participate voluntarily, provide informed consent, and engage in two rounds of consultations.

A total of 15 experts were recruited, and their authority and expertise were gauged through a self-assessment of familiarity with the intervention plan and judgment criteria to ensure they provided a balanced and representative panel.

Implementation of Expert Consultation

In the first round of consultations held in February 2023, we distributed consultation questionnaires to experts via electronic communication channels, including email and WeChat, with a specified 1-week deadline for responses. To ensure the completeness and accuracy of the responses, we implemented rigorous quality control measures and promptly took follow-up actions to address any missing or unclear information.

Following a thorough analysis of the consultation results, we conducted project selection based on average importance scores and coefficients of variation. Projects meeting the predetermined criteria were retained, ie, projects with an average importance score ≥4 and a coefficient of variation <0.25.²³ Any discrepancies among expert opinions were carefully reviewed by the research team. Using the feedback from the experts, we refined and adjusted the intervention plans to enhance their effectiveness and relevance.

Subsequently, in the second round of consultations held in June 2023, similar protocols were adopted. The consultation outcomes indicated a growing consensus among the experts, ultimately signaling the conclusion of the consultation process.

Throughout this period, we conducted consultations and discussions via electronic communication channels, rigorously maintaining quality, and adjusted and improved the plans based on expert feedback to ensure the efficiency and relevance of the final plan.

Statistical Methods

Data analysis was conducted using SPSS 22.0 software. Descriptive analysis was employed to depict the data using measures such as the mean, standard deviation, and coefficient of variation. Furthermore, the level of expert engagement was reflected by the questionnaire response rate, providing insight into the experts’ attentiveness and participation in the study. To assess the authority of the experts, we introduced the Expert Authority Coefficient (Cr), which was calculated as follows: Cr = (Ca + Cs)/2, where Ca represents the experts’ judgment basis for the indicators and Cs indicates their familiarity with the research content. By considering both the experts’ evaluation criteria and their familiarity with the research content, we derived a comprehensive Expert Authority Coefficient to assess their contributions and influence on the study. To evaluate the consistency of expert opinions on various indicators, and thus, the stability of the expert panel, we calculated Kendall’s concordance coefficients for each indicator was calculated. Additionally, the Analytic Hierarchy Process (AHP) was utilized to calculate the weights of each indicator and their combined weights, followed by consistency testing. The results reflected the importance of each indicator in the overall study and for evaluating the interrelationships and influences among them. Finally, a significance level of P < 0.05 was applied to determine whether differences observed in the data analysis results were statistically significant.

Results

Expert Demographic Information

A total of 15 hematologic disease experts and 15 psychology experts from eight tertiary hospitals in Beijing were selected to participate in two rounds of consultations.

In the first round of consultations, the 15 experts included 4 experts aged between 30 and 39 years, 8 aged between 40 and 49 years, and 3 aged 50 years or older. Additionally, 9 experts held a master’s degree or higher, while 8 held an associate senior professional title or higher. Moreover, this panel included 8 experts specializing in hematology and 5 specializing in psychology, with 2 experts serving in administrative roles.

In the second round of consultations, the 15 experts included 3 aged between 30 and 39 years, 8 aged between 40 and 49 years, and 4 aged 50 years or older. Furthermore, 7 experts held a master’s degree or higher, while 10 held an associate senior professional title or higher. Additionally, this panel included 9 experts specializing in hematology and 4 specializing in psychology, with 2 experts serving in administrative roles.

These experts were chosen for their diverse backgrounds, qualifications, and expertise to ensure the provision of comprehensive insights and perspectives in the consultation process.

Expert Engagement and Authority

In the two rounds of consultations, a total of 15 questionnaires were collected for each round, for a response rate of 100% in both rounds. During the first round of consultations, 8 experts (53.33%) provided modification suggestions, while in the second round, 2 experts (13.33%) offered modification suggestions.

For the experts in the first round of consultations, the calculated Expert Judgment Basis (Ca), Familiarity with Content (Cs), and Expert Authority Coefficient (Cr) values were 0.882, 0.809, and 0.846, respectively. For those in the second round of consultations, the calculated Ca, Cs, and Cr values were 0.92, 0.83, and 0.875, respectively.

These statistical results indicated a high level of engagement among the experts, with a majority providing valuable feedback during the first round of consultations. The consistent participation and contribution of experts across both rounds underscore the robustness and credibility of the consultation process. Moreover, the calculated Cr values reflect the combined influence of experts’ judgment basis and familiarity with the research content, further affirming the reliability and expertise of the consulted panels.

Degree of Expert Opinion Coordination

The coefficient of coordination for the two rounds of expert consultations yielded P values ranging from 0.002–0.000, with coefficients of variation ranging from 0–0.32. These results indicate that the opinions of the experts trended towards consensus, and the degree of coordination progressively increased. The statistically significant P values indicate a high level of agreement among the opinions and suggestions of the experts. Additionally, the low coefficient of variation suggests a minimal degree of variability in the experts’ responses across both rounds of consultations. These findings underscore the effectiveness of the consultation process in fostering consensus and coherence among the experts. The increasing degree of coordination observed over the two rounds further validates the reliability and robustness of the expert opinions obtained, enhancing the credibility of the study outcomes.

Expert Consultation Feedback

Following the first round of expert consultations, modifications were made to items of the MBSR therapy for HM patients based on the selection criteria and expert opinions, as outlined below:

Revision of Inclusion and Exclusion Criteria

• Modified the diagnostic criteria for HM to include patients diagnosed with HM confirmed by bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) ± pathological examination.
• Adjusted the expected survival period to ≥3–6 months.
• Excluded individuals who had taken psychotropic drugs in the previous month or had undertaken mindfulness-related courses systematically and/or persistently.
• Eliminated criteria such as intervention interruptions occurring four or more times due to disease exacerbation or physical reasons, and inability to continue participating in the program due to uncontrollable factors.

Refinement and Revision of Intervention Frequency and Duration

• The intervention duration was set at 8 weeks, with weekly group sessions held on Fridays at 3:00 PM for 45–60 min.
• Participants were required to engage in homework exercises and daily supervision for at least 3–5 days per week. Exercise content was posted by researchers in WeChat groups, and participants could check in daily after completing their exercises. They were encouraged to share insights, experiences, and photographs, and researchers would provide positive feedback upon successful check-ins.

Refinement and Revision of Intervention Themes and Content

• Mindful breathing was moved from the third week to the first week, while body scanning was shifted from the first week to the third week.
• Mindful eating was moved from the sixth week to the second week.
• “Mindful walking” was changed to “walking meditation” based on expert suggestions that mindful walking sessions are typically short, lasting 10–15 min, and can be interspersed with quiet practices such as mindful breathing and body scanning. Encouraging mindfulness during daily walks led to this modification.

Following the second round of expert consultations, no items were added or removed. However, the food item “chocolate” in the mindful eating theme was replaced with “raisins” due to concerns raised by experts regarding the melting nature of chocolate and its inapplicability to all patients. Additionally, experts suggested extending the duration of weekly group sessions to 1.5 or 2 h to accommodate practice time, considering that 45 min to 1 h might be insufficient. However, this recommendation was tempered by considerations for the physical condition of the patients, necessitating respect for their practical circumstances.

Finally, the MBSR therapy for HM patients constructed in this study included 2 primary items, 9 secondary items, and 27 tertiary items (Table 1).

Table 1 Components of Mindfulness-Based Stress Reduction (MBSR) Therapy for Patients with Hematologic Malignancies (HM)

Discussion

Using the Delphi methods, this study developed an MBSR therapy program tailored for patients with HM. The program consists of 2 primary items, 9 secondary items, and 27 tertiary items, ensuring comprehensive coverage of content. To the best of our knowledge, this is the first available MBSR therapy program designed specifically to provide effective psychological support and physiological adjustment for patients with HM.

Scientific Reliability of MBSR Therapy Program for HM Patients

The MBSR approach, proposed by Dr. Jon Kabat-Zinn,²⁴ is an effective intervention method for supporting the maintenance of mental health. It is primarily used to correct sub-health states, improve emotional management, and treat various psychological issues. It is also applied to assist patients with managing various physiological discomforts caused by clinical diseases. Currently, the MBSR approach is mostly based on the intervention method established by Dr. Kabat-Zinn.²⁵ The program developed in the present study is also based on this approach, which involves conducting a literature review to search, organize, and analyze related studies on MBSR both in domestic and international populations. Ultimately, two Chinese articles and ten English articles were included. Based on the results of the literature search, a systematic review of MBSR for HM patients was formed, and a preliminary draft of the MBSR program for HM patients was developed, which has been published.²⁶

The Delphi method, introduced and conceptualized by the Rand Corporation in 1964, is a consulting and decision-making technique that is applicable across diverse fields. Central to its approach is the anonymous solicitation of input from a panel of experts through multiple rounds of consultation.²⁷ In the present study, the Delphi expert consultation method was then employed, with two rounds of expert consultations conducted to revise and refine the indicators, ensuring the scientific validity and reliability of the constructed intervention program. As described in the Results section, the response rates of 100% for both consultation rounds indicated that the experts were actively engaged in each survey. Regarding the professionalism of the experts, the authority coefficients were 0.846 and 0.875 in the first and second rounds, respectively. Given that other studies typically use 0.7 as the threshold,²⁸ the coefficients in the present study demonstrate that the experts had a higher level of authority in terms of self-assessment. Additionally, the convergence of expert views and the increasing degree of harmonization were observed during the two rounds of expert consultations.

Specificity of MBSR Therapy Program for HM Patients

Malignant hematologic diseases comprise a group of malignant clonal disorders originating from the bone marrow, lymphoid tissue, and blood, including various types of leukemia, lymphoma, and myelodysplastic syndromes.²⁹ Because these diseases are highly malignant, they are challenging to treat and pose dual challenges to both the physical and mental health of patients. Previous studies have shown that psychological support and intervention have a positive impact on the mental health and quality of life of patients.³⁰ However, challenges persist in the provision of psychological intervention for patients with HM, and more effective and comprehensive approaches are needed to help patients cope with the physical and mental distresses caused by these diseases. The 8-week intervention program proposed in this study is rooted in MBSR and customized to suit the characteristics and physical condition of patients with HM, thus ensuring a highly specific approach to MBSR for this patient population. The program is designed to progress gradually, starting from simple exercises and advancing to more complex ones, transitioning from static to dynamic movements and incorporating a combination of both. It evolves from lying to sitting to standing to stretching, gradually guiding patients towards embracing life fully while establishing mindfulness both physically and psychologically. Safety is prioritized throughout the intervention, with medical staff accompanying patients during mindfulness exercises. Patients are encouraged to rest or discontinue exercises if they experience any discomfort. Particularly in the “Mindful Stretching” component, patients are not pressured to perform exercises beyond their capabilities; instead, they are encouraged to acknowledge and accept their body’s sensations in each moment. When engaging in stretching or balancing exercises, patients learn to peacefully coexist with any discomfort they may experience.

Strengths and Innovations

The strengths and innovations of this project are primarily manifested in the following aspects. The first is personalization and integration: the MBSR treatment plan developed in this study fully considers the special needs and challenges of patients with malignant hematologic diseases. It integrates various elements such as mindfulness meditation, cognitive-behavioral strategies, and physical stretching in a progressive and comprehensive manner. This holistic approach, ranging from static to dynamic exercises and from lying down to sitting to standing positions, aims to enhance patients’ psychological health and quality of life comprehensively. The second aspect related to self-management and coping skills: MBSR therapy emphasizes cultivating patients’ acceptance and awareness of their current situation as well as their ability to effectively cope with stress and emotions. By learning mindfulness techniques, patients can better cope with the discomfort and challenges they experience during treatment, enhancing their self-management and self-regulation abilities. This self-management ability not only helps alleviate patients’ psychological pressure but also enhances their adaptation to the disease, improving treatment outcomes. A third aspect is physiological and immune regulation: in addition to its positive effects on psychological health, MBSR therapy has been shown to regulate physiological and immune functions to some extent. This is particularly important for patients with HM, as it can help them better cope with treatment side effects and enhance their physical resistance. Through mindfulness practice, patients can regulate physiological responses to reduce physical discomfort and strengthen their immune system, thereby reducing the economic burden on patients and helping them to better cope with the impact of the disease. An important fourth aspect is the program’s practicality and generalizability: MBSR therapy is worth promoting due to its simplicity, environmental friendliness, wide applicability, and good clinical outcomes. Additionally, the intervention protocol developed in this study specifically for patients with HM further enriches the content of MBSR therapy, making it more practical.

While this study focused on psychological outcomes (anxiety, depression, sleep quality), future research should explore the potential impact of this MBSR program on long-term clinical outcomes, such as overall survival (OS) and disease-free survival (DFS). Preliminary evidence in other cancer populations suggests mindfulness interventions may indirectly influence survival through improved treatment adherence and immune modulation, but further randomized controlled trials (RCTs) in HM patients are needed to validate these associations.

Conclusion

Through a comprehensive literature search and two rounds of expert consultations, an MBSR therapy program was devised specifically for patients with HM, comprising 2 primary items, 9 secondary items, and 27 tertiary items. The program demonstrated scientific reliability, specificity to HM patients’ needs, and practical innovation. Next, we will conduct a randomized controlled trial to evaluate its efficacy in improving psychological outcomes (anxiety, depression) and explore potential impacts on clinical outcomes such as treatment adherence and quality of life. Limitations of this study include potential selection bias in expert recruitment (focused on Beijing tertiary hospitals) and the need for multi-center validation to enhance generalizability. This program provides a standardized framework for integrating mindfulness-based interventions into clinical and psychosocial oncology care for HM patients in China.