Music Video for AYA-Parent Communication and Resilience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 16
- 主要终点
- Parent family environment measured by the Family Adaptability and Cohesion Scale
研究概览
简要总结
This randomized trial studies how well music therapy and parents' education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents. Making a music therapy video may improve communication, emotional distress, and recovery in younger patients undergoing treatment for cancer. It is not yet known whether music therapy and counseling for parents is more effective than information handouts for parents in improving communication and emotional distress in patients undergoing treatment for cancer.
详细描述
PRIMARY OBJECTIVES:
I. Compare the efficacy of a Therapeutic Music Video (TMV) intervention with a Therapeutic Music Video plus Parent (TMV+P) intervention on outcomes for adolescents/young adults (AYA) undergoing treatment for high-risk cancer.
II. Compare the efficacy of a TMV intervention with a TMV+P intervention on outcomes for parents of AYA with high-risk cancer.
III. Determine relationships of parent distress and parent perceived family environment with AYA outcomes using a mixed methods approach. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to age in years (11-13 vs 14-17 vs 18-24). Parents are randomized to 1 of 2 intervention arms.
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
- Single (Investigator)
入排标准
- 年龄范围
- 11 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AYA has initial or relapsed cancer diagnosis and is actively on treatment and will continue to be on treatment long enough to complete the intervention and evaluation (4 to 6 weeks)
- •AYA meets at least 1 of 3 criteria indicating potentially high palliative care or end-of-life needs:
- •Any high-risk cancer (i.e., metastatic or stage IV)
- •Receiving moderate- to high-intensity chemotherapy during 3-5 consecutive days in an in- or out-patient setting
- •A diagnosis with an estimated 5-year event-free survival of < 50%
- •AYA is able to participate in sessions as evaluated by the Karnofsky/Lansky score of 50% or greater
- •One consistent parent is willing and available to participate in all parent and evaluation sessions
- •AYA is not married and has no children
- •AYA and parent are able to read, understand, and speak English
排除标准
- •Cancers not usually occurring in childhood/adolescent or young adult populations, such as lung or prostate cancer
- •Cognitive impairments that would make it difficult for AYA/parents to participate in the intervention or complete questionnaires (determination in consultation with attending physician, oncologist, and, for adolescents below age 18, the parents)
结局指标
主要结局
Parent family environment measured by the Family Adaptability and Cohesion Scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent family environment measured by the Parent-Adolescent Communication scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent family environment measured by the Perceived Social Support-Health Care Providers
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA illness-related distress measured by the Mishel Uncertainty in Illness Scale and the McCorkle Symptom Distress scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable analysis of covariance (ANCOVA) to account for measurement error and to reduce the number of comparisons.
AYA social integration measured by the Perceived Social Support-Family scale, the Perceived Social Support-Friends scale, and the Perceived Social Support-Health Care Providers
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parental distress measured by the Perceived Stress Scale, the Profile of Mood States-Short Form, and the Spielberger's State-Trait Anxiety Inventory-State Component
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA defensive coping measured by the Jalowiec Coping Scale-Revised
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA family environment measured by the Family Adaptability and Cohesion Scale II
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA family environment measured by the Parent-Adolescent Communication scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA family environment measured by the Family Strengths Scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA spiritual perspective measured by the Reed Spiritual Perspective Scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA positive coping measured by the Jalowiec Coping Scale-Revised
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA hope-derived meaning measured by the Herth Hope Index
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA self-transcendence measured by the Reed Self-Transcendence scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
AYA resilience measured by the Nowotny Confidence subscale, the Haase Resilience in Illness Scale, and the Index of Well-Being
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent family environment measured by the Family Strengths Scale
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Parent quality of life measured by the Index of Well-being
时间窗: Up to 90 days
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
次要结局
未报告次要终点