Being Present-MPN: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs and CML on Tyrosine Kinase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Frequency of Primary Symptoms
研究概览
简要总结
This trial looks at how well a distress reduction intervention, called "Being Present", works to improve the quality of life of patients with BCR-ABL-negative myeloproliferative neoplasms (MPNs) or chronic phase chronic myeloid leukemia (CP-CML) who are taking tyrosine kinase inhibitors (TKIs) and their caregivers. Mindfulness meditation is the practice of repeatedly bringing attention back to the immediate experience and may help people cope with various types of illness, stress, and worry. This may help patients and caregivers to gradually learn to disconnect from reacting to and dwelling on the past and future and instead fully experiencing the present moment.
详细描述
PRIMARY OBJECTIVES:
I. To tailor the Being Present intervention to BCR-ABL-negative MPN and CP-CML patients.
II. To determine the feasibility of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, and CP-CML patients on tyrosine kinase inhibitors (TKIs), and CP-CML patients in treatment-free remission (TFR).
III. To determine the acceptability of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, CP-CML patients on TKIs, CP-CML patients on TKIs, and CP-CML patients in TFR.
SECONDARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENT: Carry a diagnosis of BCR-ABL-negative MPN or CML
- •PATIENT: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
- •PATIENT: Be able to speak and read English
- •PATIENT: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- •PATIENT: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
- •PATIENT: Be able to provide informed consent
- •CAREGIVER: Be a spouse/partner, other family member, or a close friend of a BCR-ABL-negative patient who consented to participate in the Being Present-MPN study
- •CAREGIVER: Be able to speak and read English
- •CAREGIVER: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- •CAREGIVER: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
- •CAREGIVER: Be able to provide informed consent
排除标准
- •PATIENT: Have had their BCR-ABL-negative MPN transform into acute leukemia
- •PATIENT: Have had their CP-CML transform into blast phase
- •PATIENT: Be post-allogeneic stem cell transplantation
- •PATIENT AND CAREGIVER: Have extensive hearing loss such that ability to participate in the study would be impaired
结局指标
主要结局
Frequency of Primary Symptoms
时间窗: Up to 90 days
The frequency of primary symptoms will be categorized and assessed by semi-structured qualitative interviews.
Frequency of Participants' Understanding of Hematologic Malignancies
时间窗: Up to 90 days
The frequency and categorization of participants' understanding of hematologic malignancies will be assessed by semi-structured qualitative interviews.
Frequency of Participants' Perception of web-based mindfulness meditation
时间窗: Up to 90 days
The frequency and categorization of participants' perception of web-based mediation will be assessed by semi-structured qualitative interviews.
Frequency of Reported Barriers of Web-Based Mindfulness Meditation
时间窗: Up to 90 days
The frequency and categorization of participants' reported barriers to web-based mediation will be assessed by semi-structured qualitative interviews.
Percentage of patients approached who consent to participate
时间窗: Up to 90 days
Recruitment rate will be reported as a percentage of all patients who were approached by the study team or medical professional whom consented to participate in the active study.
Frequency of Reasons for Ineligibility
时间窗: Up to 90 days
For potential study candidates who are ineligible, caregiver relationship and reasons for ineligibility will be collected. Reasons for ineligibility will be reported using descriptive statistics.
Frequency of Reasons for Refusal to Participate
时间窗: Up to 16 weeks
For potential study candidates who decide not to participate, caregiver relationship and reasons for refusal will be collected. Reasons for refusal will be reported using descriptive statistics.
Frequency of Attrition over time
时间窗: Up to 16 weeks
The number of participants who attend the web-based sessions will be recorded via a roll-call and recorded at each study visit.
Frequency of Attrition Causes
时间窗: Up to 16 weeks
Reasons for not attending the web-based interventions will be recorded and characterized. Reasons for attrition will be reported using descriptive statistics.
Frequency of meditation practice
时间窗: Up to 16 weeks
The study team will call participants and conduct a brief interview to gauge current mindfulness meditation practice. Frequency of mediation will be reported using descriptive statistics.
Median duration of meditation practice
时间窗: Up to 16 weeks
The study team will call participants and conduct a brief interview to gauge current duration of mindfulness meditation practice. Duration of mediation will be reported using descriptive statistics.
Frequency of playing recorded webinars
时间窗: Up to 16 weeks
The frequency in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics
Duration of playing recorded webinars
时间窗: Up to 16 weeks
The duration in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics
Measure of Acceptability using semi-structured interviews
时间窗: Up to 16 weeks
Information about acceptability and the overall intervention experience will come from semi-structured interviews. Audio recordings of the semi-structured interviews will be professionally transcribed and coded using Atlas.ti for categorizing acceptability using qualitative thematic analysis by at least two investigators.
次要结局
- Mean change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores(Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total)
- Mean change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale(Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total)
- Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total)
- Mean change in scores on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)(Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total)
- Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CML24)(Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total)
- Mean change in scores on the Caregiver Quality of Life Index - Cancer (CQOLC)(Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total)
- Mean change in scores on the Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)(Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total)