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临床试验/NCT05551286
NCT05551286已完成不适用

The 'Young Adult Taking Action' Programme for Young Adult Cancer Survivors: a Feasibility Study Evaluating Content and Delivery

REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
Acceptability; Affective attitude

研究概览

简要总结

Young adult cancer survivors (YACS) aged 18-39 report physical and psychosocial late effects following cancer treatment, impairing quality of life and participation in everyday life. To address such multifactorial challenges complex or multicomponent rehabilitation interventions are needed. Based on this, the 'Young Adult Taking Action' (YATAC) programme was developed to increase participation in everyday life and improve health-related quality of life. The development of the intervention is guided by the British Medical Research Council's guidance (MRC) and the framework for the co-production and prototyping of public health interventions by Hawkins et al.

The present study will investigate the acceptability and fidelity of the intervention at the research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care in Nyborg, Denmark. A mixed method one-armed feasibility study will be conducted and the results of the study will be used to revise version 1.0 of the programme.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being between 18-39 years old at baseline
  • Have had any type of cancer
  • Have completed primary/active cancer directed treatment (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention, while current hormonal treatments or maintenance therapies are permissible)
  • Determined a need for rehabilitation determined by the REHPA scale (a linear analogue scale, where the participants indicate how close they are to living the life they desire after ending cancer treatment). The scale ranges from 0= 'goal reached' to 9= 'infinitely far from'
  • Have access to a device with Internet options (i.e., smartphone or tablet)

排除标准

  • Dependent in basic personal activities of daily living (personal care, dressing and eating)
  • No permanent residence in Denmark
  • Not able to speak and understand Danish

结局指标

主要结局

Acceptability; Affective attitude

时间窗: 10 weeks

The participants feelings about the intervention. Scores between 0-5, with higher scores indicating better feeling.

Fidelity

时间窗: 10 weeks

Defined as the consistency of whether the intervention was implemented as intended. The professionals register to what extent they have implemented the session as intended on a 5-point Likert scale. Scores between 0-5, with higher scores indicating higher consistency.

Dose

时间窗: 10 weeks

Defined as the quantity of intervention implemented. The professionals will report the number of elements implemented and the time used. In addition, the professional will give information on reasons for deviation from the manual.

Adaptions

时间窗: 10 weeks

Defined as any adjustments made to the intervention. The professionals register and describe any adaptions they make and the reasons for this.

Acceptability; burden

时间窗: 10 weeks

The participants perceived amount of effort required to participate. Scores between 0-5, with higher scores indicating high degree of effort.

Acceptability; Ethicality

时间窗: 10 weeks

The participants opinion about the intervention's fit with their individuals value system. Scores between 0-5, with higher scores indicating higher consistency with value system.

Acceptability; intervention cohesion

时间窗: 10 weeks

The participants understanding of the intervention and how it works. Scores between 0-5, with higher scores indicating higher understanding of the intervention.

Acceptability; opportunity costs

时间窗: 10 weeks

The participants experience of opportunity costs, like benefits, values, or profits that must be given up to engage in the intervention. Scores between 0-5, with higher scores indicating higher degree of giving up on opportunity costs, like benefits, values, or profits.

Acceptability; Perceived effectiveness

时间窗: 10 weeks

The participants experience of perceived effectiveness of the intervention. Scores between 0-5, with higher scores indicating higher degree of perceived effectiveness of the intervention.

Acceptability; Self-efficacy

时间窗: 10 weeks

The participants confidence that they can perform the behavior(s) required to participate in the intervention. Scores between 0-5, with higher scores indicating higher confidence that they can perform the behavior(s) required to participate in the intervention.

次要结局

未报告次要终点

研究者

发起方
REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
申办方类型
Other
责任方
Sponsor

研究点 (2)

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