Promoting Post-traumatic Growth in Cancer Patients: a Study Protocol for a Randomized Controlled Trial of Guided Written Disclosure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in post-traumatic growth from baseline to post-intervention assessment and at 6 months follow-up. Post-Traumatic Growth Inventory (PTGI) will be used to assess this outcome
研究概览
简要总结
This study aims to investigate the efficacy of Guided Written Disclosure Protocol (GWDP) in promoting post-traumatic growth through a process of meaning reconstruction in cancer patients at the end of chemotherapy. Also, the intervention (GWDP) intends to reduce distress symptoms (i.e. intrusive thoughts, avoidance, depression and anxiety).
详细描述
Study aims The primary aim of this study is to assess the efficacy of the Guided Written Disclosure Protocol in promoting post-traumatic growth in stage I-III breast and colon cancer patients at the end of their adjuvant chemotherapy.
The secondary aims of the study include
- Evaluating the efficacy of the GWDP in terms of intrusive thoughts and avoidance reduction
- Assessing the efficacy of the GWDP in terms of reduction of depression and anxiety
- Investigating the relationship between constructed meaning and post-traumatic growth.
Methods Study design The study is a randomized controlled trial. Eligible patients who give their consent to participate in the study will be randomized to receive the GWDP intervention (experimental group) or a control intervention (control group).
Participants Participants will be recruited in the Oncological Day Hospitals (DH) of the Scientific Research and Care Institute (IRCCS) Santa Maria Nuova Hospital of Reggio Emilia - Oncology Unit
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A histologically-confirmed stage I-III breast or colon cancer
- •Adjuvant chemotherapy completed by no more than eight months
- •Disease free (no evidence of metastatic disease) according to what reported by the oncologist during the follow-up oncological consultation
- •Aged 18 years or over
- •Property of written and spoken Italian language
排除标准
- •Having received a structured psychological intervention performed by a psychologist or by a psychiatrist, for at least six months during the last three years
- •Having received a psychopharmacological treatment for a codified psychiatric disorder (according to the DSM-V) during the last three years
结局指标
主要结局
Change in post-traumatic growth from baseline to post-intervention assessment and at 6 months follow-up. Post-Traumatic Growth Inventory (PTGI) will be used to assess this outcome
时间窗: Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.
21-item questionnaire
次要结局
- Change in intrusive thoughts and avoidance from baseline to post-intervention assessment and at 6 months follow-up. Impact of Event Scale (IES) will be used to assess this outcome(Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.)
- Change in constructed meaning from baseline to post-intervention assessment and at 6 monts follow-up. Constructed Meaning Scale (CMS) will be used to assess this outcome(Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.)
- Change in anxiety and depression from baseline to post-intervention assessment and at 6 months follow-up. Hospital Anxiety and Depression Scale (HADS) will be used to assess this outcome(Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.)