The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for Adolescents and Young Adults receiving Hematopoietic Cell Transplantation

促进压力管理复原力 (PRISM) 干预：一项针对接受造​​血细胞移植的青少年和年轻人的多中心随机对照试验

• 批准号: 10310773
• 负责人: Abby R Rosenberg
• 金额: $ 5.22万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10310773
• 关键词: Adherence; Adolescent and Young Adult; Affective Symptoms; Age; Anxiety; Cancer Burden; Cancer Relapse; Caring; Data Collection; Development; Disease; Goals; Health behavior; Hematologic Neoplasms; Intervention; Knowledge; Mental Depression; Mental Health; Methodology; Morbidity - disease rate; Newly Diagnosed; Oral; Outcome; Parents; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Phase; Procedures; Quality of life; Randomized Controlled Trials; Reporting; Resources; Risk; Site; Spouse Caregiver; Vocation; Vulnerable Populations; age group; age related; anxiety symptoms; brief intervention; cancer diagnosis; evidence base; experience; health related quality of life; hematopoietic cell transplantation; high risk population; improved; meetings; mindfulness; novel; psychological distress; psychosocial; randomized trial; recruit; reduce symptoms; resilience; skills; stress management; treatment as usual

PROJECT ABSTRACT The experience of hematopoietic cell transplantation (HCT) for hematologic malignancy among Adolescents and Young Adults (AYAs) is particularly difficult because age-related developmental challenges of identity, relationships, and vocation may add to the burden of cancer. Compared to other age-groups, AYAs have poorer psychosocial outcomes including increased anxiety and depression and poorer adherence to oral immunosuppressive medications potentially predisposing AYAS to disease-related morbidity and and/or cancer-relapse. A potential barrier to improving these experiences may be that AYAs have few opportunities to develop the personal resources needed to handle adversity. We have previously developed the “Promoting Resilience in Stress Management” (PRISM) intervention for AYAs with serious illness. This manualized, brief intervention is delivered in 4, 30-60-minute, one-on-one sessions, followed by a Parent/ Caregiver/ Spouse/ significant other inclusive meeting. It targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. Findings from a phase 2 randomized controlled trial among AYAs with newly diagnosed cancer demonstrate that PRISM is associated with decreased psychological distress and increased health-related quality of life. This study will build on our prior experience and fill a critical knowledge gap regarding PRISM’s impact among AYAs receiving HCT. Thus, we will conduct a multi-site randomized controlled trial among N=70 AYAs (n=35 PRISM and n=35 usual care; ages 12-24 years), with the primary trial outcome of patient-reported symptoms of anxiety and depression. We hypothesize that AYAs who receive PRISM will report fewer mixed affective symptoms, demonstrate better adherence, and show improved biomedical outcomes, while their parents report improved quality of life and psychological distress. This study offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence- based psychosocial interventions and standards of care for AYAs with hematologic malignancies and has the potential to reduce the burden of cancer in these vulnerable populations. In this proposed diversity supplement, I will contribute to evaluating PRISM’s efficacy in reducing symptoms of anxiety and depression over the first 6-months post-HCT by assisting with procedure related to recruitment, data collection, and analysis.

项目摘要