Determining the Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of In-home Body Image (BI) -Focused Expressive Writing (EW) Intervention for Post-treatment Adolescent and Young Adult (AYA) Cancer Survivors With BI Distress (Practicality)
研究概览
简要总结
Each year, about 89,500 adolescents and young adults (AYAs; 15-39 years old) are diagnosed with cancer and up to 60% experience body image (BI) distress. BI is largely developed in adolescence and young adulthood and has implications for self-identity and quality of life. Cancer itself and its associated treatments precipitate changes to appearance as well as body sensation and function, all of which can alter BI and lead to increased anxiety. An in-home BI-focused expressive writing (EW) program offers a promising outlet for addressing BI distress and anxiety in a way that eliminates constraints of clinical time and specialist availability.
There are no recommended interventions to help AYA cancer survivors cope with BI distress. To address this knowledge gap, the objective of this this pilot randomized-controlled trial is to determine the feasibility of a four-week BI-focused EW intervention to decrease BI distress and anxiety among AYA cancer survivors with the hypothesis that this intervention will reduce BI distress and anxiety.
详细描述
Protocol was updated to make the previous secondary outcome measures now exploratory
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
- 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
- •Age 15-39 years
- •History of one or more cancer diagnoses with all treatment (surgery, chemotherapy, radiation) completed ≥ 3 months before enrollment)
- •BIS ≥10 at time of screening
- •Ability to provide consent or assent and parental consent if applicable.
排除标准
- •Plan to receive surgery, radiation, chemotherapy (including biologic agents, immunotherapy, and other targeted agents) for cancer treatment during the study period (from baseline assessment through post-four-week assessments and interview). Participants may continue with surveillance (such as imaging or biopsies) during the study period.
- •Initiation of new treatments for body image distress or anxiety (e.g., pharmacologic, psychotherapy) ≤8 weeks prior to study enrollment. Although, participants may continue psychosocial or pharmacological treatments for anxiety or body image distress if the treatment were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant body image distress.
- •History of limb-altering surgery or amputation (surgical exclusions are based on the premise that significant appearance-altering surgeries may impact body image distress differently than other cancer therapies)
- •Currently receiving end-of-life care
研究组 & 干预措施
Expressive Writing (EW)
four- week, in- home, Body Image (BI)- focused EW intervention
干预措施: BI Focused writing (Other)
Attention Control
four- week control writing program
干预措施: Control (Other)
结局指标
主要结局
Feasibility of In-home Body Image (BI) -Focused Expressive Writing (EW) Intervention for Post-treatment Adolescent and Young Adult (AYA) Cancer Survivors With BI Distress (Practicality)
时间窗: 7 months
75% of participants complete the baseline and four-week patient-reported measures
Feasibility of In-home Body Image (BI) -Focused Expressive Writing (EW) Intervention for Post-treatment Adolescent and Young Adult (AYA) Cancer Survivors With BI Distress (Recruitment)
时间窗: 6 months
percent of patients recruited within 6 months
Feasibility of In-home Body Image (BI) -Focused Expressive Writing (EW) Intervention for Post-treatment Adolescent and Young Adult (AYA) Cancer Survivors With BI Distress (Adherence)
时间窗: 7 months
percent of patients who completed both the baseline and four week patient reported measures and considered adherent to treatment
次要结局
未报告次要终点