Department of Nursing, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital; Shanghai Key Laboratory of Radiation Oncology; and Shanghai Engineering Research Center of Proton and Heavy Ion Radiation Therapy, Shanghai, China.
Department of Nursing, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital; Shanghai Key Laboratory of Radiation Oncology; and Shanghai Engineering Research Center of Proton and Heavy Ion Radiation Therapy, Shanghai, China
BMJ Open. 2024 Sep 5;14(9):e085551. doi: 10.1136/bmjopen-2024-085551.
The head and neck comprise vital organs and are apparent human body parts. Tumours here impair physical and sensory functions as well as appearance and social interactions, leading to body image distress (BID) and threatening mental health and quality of life. Acceptance and commitment therapy has shown effectiveness in improving BID in groups such as breast cancer patients. This study aims to apply this therapy to intervene in head and neck cancer (HNC) patients, aiming to improve BID and promote better psychological well-being.
This study is a prospective, parallel-group, randomised controlled trial. A total of 64 HNC patients will be allocated to either an intervention group or a control group. The intervention group will engage in a 3 week, six-session group-based acceptance and commitment therapy programme, while the control group will receive standard treatment. The primary outcome is cancer-related BID, and secondary outcomes are HNC-related BID, psychological flexibility, coping style and psychological distress. These indicators will be measured at baseline, postintervention and 1 month following the intervention's completion.
The trial has received approval from the Institutional Review Board of Shanghai Proton and Heavy Ion Hospital (2308-67-02). The study results will be shared through peer-reviewed journals and conferences.
ChiCTR2300077863.
头颈部包含重要器官,也是明显的人体部位。这里的肿瘤会损害身体和感官功能,以及外观和社交互动,导致身体意象困扰(BID),并威胁到心理健康和生活质量。接受和承诺疗法已在乳腺癌患者等群体中显示出改善 BID 的有效性。本研究旨在将这种疗法应用于头颈部癌症(HNC)患者,旨在改善 BID 并促进更好的心理幸福感。
这是一项前瞻性、平行组、随机对照试验。共有 64 名 HNC 患者将被分配到干预组或对照组。干预组将参加为期 3 周、共 6 节的基于群体的接受和承诺治疗方案,而对照组将接受标准治疗。主要结局是癌症相关的 BID,次要结局是 HNC 相关的 BID、心理灵活性、应对方式和心理困扰。这些指标将在基线、干预后和干预完成后 1 个月进行测量。
该试验已获得上海质子重离子医院机构审查委员会的批准(2308-67-02)。研究结果将通过同行评议的期刊和会议进行分享。
ChiCTR2300077863。