Determining the Feasibility of Virtual, Tailored, Music-Based Relaxation for Anxiety in Adolescent and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Acceptability of TiMBRe
研究概览
简要总结
Demonstrate the feasibility of conducting an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in adolescent and young adult (AYA) cancer survivors with clinically-relevant anxiety.
详细描述
Initially Sessions 7 and 8 were both body percussion; however, the 04FEB2025 changed this to Session 7 will be body percussion and session 8 will be selected by the participant. This will allow for more tailoring of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 - 39 years old
- •at least one month post cancer treatment
- •report clinically relevant anxiety in the past seven days (PROMIS Anxiety 4a scores ≥ 55)35
- •speak/read English.
排除标准
- •prognosis less than 3 months
- •documentation of significant hearing impairment
- •plan to receive surgery, radiation, or chemotherapy for cancer treatment during the study period
- •plans in place to begin new psychosocial (i.e., cognitive behavioral therapy14 or mindfulness-based stress reduction15) or pharmacological treatments for anxiety during the study. Although, participants may continue psychosocial or pharmacological treatments for anxiety if the treatments were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant anxiety in the last week.
研究组 & 干预措施
TiMBRe
an eight-week, (45 min/week), theory driven, virtually-delivered, tailored music-based relaxation (TiMBRe) intervention to decrease anxiety in AYA cancer survivors with clinically-relevant anxiety.
干预措施: TiMBRe (Other)
Attention-Control
Standard of care study staff calls and cancer survivorship resources
干预措施: Control (Other)
结局指标
主要结局
Acceptability of TiMBRe
时间窗: up to 8 weeks post start of intervention
mean scores for the Acceptability E-scale Items are ≥ 4/5
Demand of TiMBRe
时间窗: up to 3 years from start of study
percent of patients recruited over three years
Adherence to TiMBRe
时间窗: From enrollment to end of treatment at 8 weeks
percent of TiMBRe participants to complete the baseline and 8 weeks patient report measures
Practicality of TiMBRe
时间窗: From enrollment to end of treatment at 8 weeks
percent of TiMBRe group participants self-report practicing music-based relaxation skills for at least 10 minutes on at least three days per week
次要结局
- Identification of facilitators and barriers to virtual TiMBRe participation(up to 8 weeks post start of intervention)
- Change in Anxiety management(at baseline and eight weeks post initiation of treatment)