Stories and Music for Adolescent/Young Adult Resilience During Transplant (SMART)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- Assess acute changes of Symptoms-related distress: Pain
研究概览
简要总结
This randomized phase III trial is studying how well music therapy works compared to listening and discussing books on tape in improving quality of life in young patients undergoing stem cell transplant. Music therapy or book discussion may improve quality of life in patients undergoing stem cell transplant. It is not yet known whether music therapy is more effective than book discussion in improving quality of life in patients undergoing stem cell transplant.
详细描述
PRIMARY OBJECTIVES:
I. Test the efficacy, in terms of resilience and quality of life, of a therapeutic music video (TMV) intervention vs listening and discussing books on tape (control group) for adolescents and young adults (AYA) undergoing autologous or allogeneic transplantation for cancer.
II. Qualitatively describe the perception of helpfulness and meaningfulness of a sub-group of both interventions for AYA and family members 100 days post-transplant.
OUTLINE: This is a randomized, controlled, limited multicenter study. Patients are randomized to 1 of 2 arms.
ARM I (books on tape [control group]): Patients undergo six 1-hour sessions twice a week for 3 weeks with a trained counselor in which they choose up to 3 books on CD and listen to the book and/or discuss their impressions and thoughts about the contents with the counselor. Patients are provided with a portable CD player to listen to the books during their hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of an oncology condition requiring allogeneic or autologous transplantation
- •Receiving or planning to receive a myeloablative treatment regimen and 1 of the following:
- •Marrow transplantation
- •Peripheral stem cell transplantation
- •Cord blood stem cell transplantation
- •Patients with cancers that do not usually occur in childhood/adolescent or young adult populations (e.g., breast or prostate cancer) are not eligible
- •Able to read and speak English
- •English does not need to be the primary language
- •Able to participate in the sessions as evaluated for alertness and engagement by the music therapist
- •No cognitive impairments that would make it difficult to participate in the intervention or complete questionnaires
- •Not married and not a parent
- •Concurrent therapy for pain control or relief of other symptoms allowed
排除标准
- 未提供
结局指标
主要结局
Assess acute changes of Symptoms-related distress: Pain
时间窗: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measure capturing information on pain. Specifically, the instrument includes a 1-item pain numeric rating scale.
Assess acute changes of Symptoms-related distress: Fatigue
时间窗: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measure capturing information on fatigue. Specifically, the instrument includes a 1-item fatigue visual analogue scale.
Assess changes in uncertainty in illness as assessed by the Mishel Uncertainty in Illness Scale
时间窗: Change from baseline, immediately after completion of study treatment and 100 days post-transplant
Mishel Uncertainty in Illness Scale-Revised (MUIS-R) consists of two factors: Complexity and Ambiguity, with higher scores indicating a high level of uncertainty. Item responses are on a 5-point Likert-type scale (ranging from 5 = Strongly Agree to 1 = Strongly Disagree
Assess acute changes of Symptoms-related distress: Anxiety
时间窗: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measure capturing information on anxiety. Specifically, the instrument includes a 5-item Anxiety scale.
Assess acute changes of Symptoms-related distress: Mood
时间窗: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
Illness-related distress will be measured by indicators of uncertainty in illness, symptom-related distress. Brief Symptoms Assessment is a self-reported measures capturing information on mood. Specifically, the instrument includes a 1-item mood scale.
Assess changes in the use of positive coping
时间窗: Change from immediately after completion of study treatment and 100 days post-transplant
Three subscales of the Jalowiec Coping Scale-Revised will measure Positive Coping (JCS): confrontive, optimistic, and supportive.
Assess changes in perceived social support from healthcare providers
时间窗: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Perceived Social Support from Health Care Providers (PSS-HCP) is a self-report, 3-point rating scale adapted by Haase from items on the Perceived Social Support-Friends scales102 to correspond to health care provider relationships. Items indicate the extent to which individuals perceive their needs for support, information, and feedback are fulfilled by health care providers.
Assess changes in Spiritual Perspective from stem cell transplantation (STC) experience
时间窗: Change from immediately after completion of study treatment, and 100 days post-transplant
Measured by indicators spiritual perspective. Reed Spiritual Perspective Scale (RSPS) is a one-factor scale that measures the saliency of spiritual beliefs and behaviors in the respondent's life.157 The response format is a 6-point Likert scale anchored with words describing the frequency of behaviors.
Assess changes of Higher Resilience: Haase Adolescent Resilience in Cancer Scale
时间窗: Change from after completion of study treatment and 100 days post-transplant
Haase Adolescent Resilience in Cancer Scale measures resilience related to illness. The scale uses a 6-point Likert-type scale ranging form: 1 (strongly disagree) to 4 (strongly agree); higher summative scores indicate greater resilience. Validity of the scales was found in predictive correlations with self-esteem, self-transcendence, confidence/mastery and quality of life. In Haase's preliminary studies, alpha reliability coefficients were 0.84 - 0.86.
Assess changes in adaptability or cohesion as assessed by FACES II
时间窗: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Family Adaptability and Cohesion Scale II (FACES II) is a self-report scale using Likert response scales and measuring the 2 factors: Adaptability or cohesion
Assess changes in the use of defensive coping
时间窗: Change from immediately after completion of study treatment and 100 days post-transplant
Defensive Coping will be measured by three subscales of the Jalowiec Coping Scale-Revised (JCS): evasive, emotive, and fatalistic coping. JCS is a self-report, 0-3 point rating scale. The items are scored for both use and effectiveness.
Assess changes in perceived social support from friends
时间窗: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Perceived Social Support from Friends (PSS-Fr) is a self-report scale using 3-point rating responses ranging from 0 to 2 designed to measure the extent to which individuals perceive that their needs for support, information, and feedback are fulfilled by friends.
Assess changes in Hope from stem cell transplantation (STC) experience:
时间窗: Change from immediately after completion of study treatment, and 100 days post-transplant
Measured by indicators of hope. Herth Hope Index (HHI) items are on a 4-point scale, ranging from 1 (strongly disagree) to 4 (strongly agree); higher summative scores indicate greater hope.
Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): NCS
时间窗: Change from after completion of study treatment, and 100 days post-transplant
Nowotny Confidence Subscale (NCS) of the Nowotny Hope Scale is a self-report of confidence in one's own ability, which uses a 4-point Likert response format of strongly agree to strongly disagree
Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): STS
时间窗: Change from after completion of study treatment, and 100 days post-transplant
Reed Self-Transcendence Scale (STS) assesses activities and perspectives individuals engage in to expand their boundaries via 4-point Likert response scales
Assess changes in Higher Resilience (self esteem, confidence, self-transcendence): SES
时间窗: Change from after completion of study treatment, and 100 days post-transplant
Rosenberg Self-esteem Scale (SES) measures attitudes toward one's self. Responses are on a 4-point Likert scale.
Assess changes in indicators of well-being and global quality of life: IWB
时间窗: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Measured by indicators of well-being and global quality of life. Index of Well-being (IWB) is a semantic differential scale describing present life using adjective extremes such as discouraging/hopeful.
Assess changes in communication with family as assessed by Parent-Adolescent Communication
时间窗: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Parent Adolescent Communication (P-AC) self-report items are on 5-point Likert scales that assess adolescents' views regarding their perceptions and experience of communicating with each parent rated separately. The two subscales, Open Family Communication and Problems in Family Communication, respectively measure positive and negative aspects of communications within a family and are scored independently.
Assess changes in perceived social support from family
时间窗: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Perceived Social Support from Family (PSS-Fa) is a self-report, 3-point response (Yes, No, I don't know) scale, designed to measure the extent to which individuals perceive that their needs for support, information and feedback are fulfilled by family.
Assess changes in indicators of well-being and global quality of life: LASA Uniscale
时间窗: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Measured by indicators of well-being and global quality of life.LASA Uniscale is a global QOL self-report one-item instrument: "Please score how you feel your life has been affected by the state of your health (any disease or treatment) during the last week".160 The item is adopted from the Southwest Oncology Group protocol, which adapted the scale from a linear analogue to categorical format with 5 response categories ranging from extremely unpleasant to normal (no change).
次要结局
- Qualitatively describe the perception of helpfulness and meaningfulness of both the low-dose and TMV interventions for AYA and family members(100 days post-transplant)