跳至主要内容
临床试验/NCT03651570
NCT03651570Unknown不适用

Implementing an e-Intervention to Reduce Anxiety Symptoms and Improve Psychosocial Oncology Uptake in Patients Newly Diagnosed With Head and Neck Cancer: Pilot Randomized Controlled Trial

Jewish General Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Feasibility of recruitment for a full trial study

研究概览

简要总结

Informed by a previous trial in general cancer patients, the investigators aim to conduct a multi-centre Phase III explanatory RCT to demonstrate a significant impact of PTSD Coach on levels of anxiety in head and neck cancer (HNC) patients, including saliva and hair cortisol as bio-immunological indicators for stress. However, prior to proposing a larger trial requiring 267 patients, the investigators aim to demonstrate feasibility of recruitment and compliance with protocol procedures in a Phase II Pilot of 60 newly diagnosed HNC patients. The EG will receive PTSD Coach + usual care, compared to two control groups (UC and AC). AC will be comprised of a game app (e.g., Tetris, Candy Crush, or Solitaire) and will be structurally equivalent to the EG to control for distraction (attention on something pleasant or a task) and the human factor involved in usage prompting (i.e., same exposure time + contacts with personnel), since either distraction or the human contact with staff may, alone, lower anxiety. From a resource allocation perspective, it is important to know if the positive effects of PTSD Coach are due to the intervention itself or to the use of an app and its usage prompting. The investigators believe that PTSD Coach will be even more effective at reducing anxiety in HNC patients, as it teaches specific CBT techniques and uses psychoeducation already found to be more effective than distraction alone.

详细描述

See above

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Newly diagnosed with HNC (all HNC sites; TNM classification system); first occurrence, progression or recurrence <4 weeks at referral.
  • Willing to complete PTSD Coach or game app within 3 weeks as they await treatment onset.
  • >18 years old
  • Alert and capable of giving free and informed consent according to referring clinician.

排除标准

  • Karnofsky Performance Status (KPS) score < 60 (rated by referring oncologists/nurses or Research Coordinator) or expected survival <6 months according to clinical judgment of physicians and/or nurses.
  • Suicidal. Present a score of ≥2 on the Beck Depression Inventory (BDI) suicide item.
  • Known diagnosis of schizophrenia or schizoaffective disorder.

结局指标

主要结局

Feasibility of recruitment for a full trial study

时间窗: 2 months post-randomization

1. Can we recruit a sufficient number (i.e., n=60 over 8 months or 8/month) of newly diagnosed head and neck cancer patients? AND 2. Can we retain a sufficient proportion (i.e., ≥85% at three months post-randomization, having completed the primary outcome) of head and neck patients in all trial arms to allow completion of a full study (n=267) in a timely fashion?

PTSD Coach app Acceptability

时间窗: 2 months post-randomization

Is the PTSD Coach app acceptable to at least 80% of newly diagnosed head and neck cancer patients, as indicated by 80% positive responses on the Pilot-Study Questionnaire (PSQ; adapted from the CSQ-8; Attkisson \& Zwick, 1982)

次要结局

  • Completion of intervention in a timely manner(2 months post-randomization)
  • Sample size calculation for full trial study(2 months post-randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Henry

Principal Investigator

Jewish General Hospital

研究点 (2)

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