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临床试验/NCT03654599
NCT03654599已完成不适用

Effects of Digital Stories Intervention on Psychosocial Well-being for Cancer Patients and Caregivers Undergoing Hematopoietic Stem Cell Transplantation

Arizona State University2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
2
主要终点
Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks

研究概览

简要总结

Patients and caregivers undergoing hematopoietic stem cell transplantation often continue to experience anxiety, depression, isolation, and other psychosocial distress. A narrative-based digital stories intervention has shown promise in a pilot study with breast cancer patients in helping to alleviate emotional distress. This study is designed to test digital stories to be viewed and discussed by other HCT patients/caregivers as a psychosocial intervention in a randomized controlled trial and to test the effects of digital stories on how 110 patient and caregiver dyads (N=220) undergoing one of the most rigorous and aggressive treatments cope with treatment-related distress through supportive open dyadic communication and emotional expression.

详细描述

Patients and caregivers undergoing hematopoietic stem cell transplantation (HCT) are at particular risk for reduced psychological and social well-being due to the rigorous and unique nature of the transplant experience, such as prolonged immunosuppression and multiple post HCT complications resulting in frequent hospitalizations. However, few studies have evaluated interventions to alleviate psychosocial distress for both patients and caregivers, and those have yielded inconclusive results. A narrative-based (storytelling) approach may be an effective intervention tool for HCT patients and caregivers coping with psychosocial distress. The preliminary data show that stories shared by individuals in which a range of emotional expression or resolutions are described, may have beneficial effects on emotional well-being. In a recent pilot study of a 3-day digital storytelling workshop, investigators produced a series of digital videos with narratives from a panel of post-HCT patients. The purpose of this study is to use these digital stories (DS), to be viewed and discussed by HCT patient/caregiver dyads, as a therapeutic intervention and to examine influences on both patients' and caregivers' psychosocial status. This cost-effective, non-invasive, and easy-to-deliver psychosocial support vehicle has never been formally tested as an intervention for HCT patients or patient-caregiver dyads.

To build upon investigators' preliminary studies and to pilot test the efficacy of this series of DS, 110 adult patients undergoing HCT at the Mayo Clinic Arizona and patient respective adult caregivers (N=220 total participants) will be randomized to either (a) an intervention using DS (dyadic exposure to four 5-minute modules) or (b) an information control (IC) video group (dyadic exposure to four videos containing only information about post-HCT care) followed by encouragement to discuss as a dyad. Exposure will occur once per week over 4 weeks via a secure web-based data collection platform (REDcap) with a weekly email notification and reminder phone call. Using investigator's model of Narrative Effects on Socio-Emotional Well-Being, we will also examine expected mediating factors to determine how stories may "work" to reduce psychosocial distress by fostering emotional processing, acceptance, and dyadic disclosure of emotions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 or older
  • recently underwent Hematopoietic cell transplantation (HCT) (within a month after hospital discharge)
  • must be able to speak, read, and write in English
  • access to a working phone and e-mail account

排除标准

  • no primary caregiver
  • cognitive impairment that prohibits completion of study assessment
  • visual or hearing impairment
  • other (e.g., provider non-approval or logistical constraints such as patient moving out of town)
  • Caregiver Inclusion Criteria:
  • age 18 or older
  • family caregivers who are identified as a primary caregiver by a patient
  • have primary responsibility for the care of patients throughout the HCT process
  • Must be able to speak, read, and write in English
  • Access to a working phone and e-mail account

结局指标

主要结局

Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks

时间窗: Baseline (T1), T2 (after 4-week intervention)

Emotional Well-Being (Reduction of Emotional Distress) will be measured using the Profile of Mood States (POMS) short version (15 items, 5-point Likert scale; 0=not at all, 4=extremely). The POMS is one of the most frequently used and validated scales in studies of psychosocial interventions for cancer patients. The POMS Total Mood Disturbance (TMD) score has been shown to be most sensitive to interventions designed to facilitate emotional expression.The POMS consists of the TMD dimensions (tension-anxiety; depression-dejection; anger-hostility; and confusion-bewilderment) (Cronbach's a = .93) to be used in the current study as the primary outcome measure; and two others (fatigue-inertia; vigor-activity) will be documented. Total of Mood Disturbance= (anxious+depression+anger+fatigue)- vigor (Range from 12 to 48). The higher values represent a worse emotional well-being.

次要结局

  • Changes From Baseline Emotional Well-being (Using the Emotional Acceptance Scale) at 4 Weeks(Baseline (T1), T2 (after 4-week intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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