Kolva Elissa, Karam Sana D, Carr Alaina L, Roberts Sydneyjane, Torkko Kathleen, Lanning Ryan, Cox-Martin Emily
Division of Medical Oncology, Department of Medicine, School of Medicine, University of Colorado - Anschutz Medical Campus, MS 8117 12801 E. 17th Ave, Aurora, CO, 80045, USA.
Department of Radiation Oncology, University of Colorado Denver - Anschutz Medical Campus, Aurora, CO, USA.
Pilot Feasibility Stud. 2022 Sep 5;8(1):199. doi: 10.1186/s40814-022-01134-9.
Cancers of the head and neck region are associated with high symptom burden and elevated levels of psychological distress. Radiotherapy (RT) is a common treatment for patients with head and neck cancer (HNC) that is associated with psychological distress related to the immobilizing nature of the treatment, frequency of treatment delivery, and side effects. Guided imagery is a relaxation technique that is beneficial in reducing psychological distress in patients with other cancer diagnoses but has not been studied in this patient population. The purpose of this study is to evaluate the feasibility and acceptability of a brief guided imagery intervention (guided imagery for treatment, GIFT) to reduce RT-related anxiety and depression in patients with HNC relative to treatment as usual (TAU).
Patients with HNC planning to receive RT will be recruited to participate in a randomized controlled trial evaluating a brief, two-session guided imagery intervention (GIFT) relative to TAU alone. Primary aims include acceptability and feasibility evaluated through quantitative and qualitative methods. Measures of anxiety and depression, symptom burden, health-related quality of life, and anxiolytic medication use will be collected at baseline, during treatment, and at 1-month follow-up.
There are no published interventions of guided imagery for anxiety and depression in patients with HNC despite its efficacy in other populations of patients with cancer. This proposed project evaluates the feasibility and acceptability of an intervention that has the potential to reduce psychological distress in a vulnerable population. Additionally, we will preliminarily examine the impact of behavioral intervention on psychological distress and the use of anxiolytic medication, a novel area of study.
Clinicaltrials.gov NCT03662698 ; registered on 9/6/2018.
头颈部癌症与高症状负担和心理困扰水平升高相关。放射治疗（RT）是头颈部癌（HNC）患者的常见治疗方法，它与因治疗的固定性质、治疗频率和副作用而导致的心理困扰有关。引导式意象是一种放松技巧，对减轻其他癌症诊断患者的心理困扰有益，但尚未在该患者群体中进行研究。本研究的目的是评估一种简短的引导式意象干预（治疗用引导式意象，GIFT）相对于常规治疗（TAU）减轻HNC患者放疗相关焦虑和抑郁的可行性和可接受性。
计划接受放疗的HNC患者将被招募参加一项随机对照试验，评估相对于单独TAU的简短的两阶段引导式意象干预（GIFT）。主要目标包括通过定量和定性方法评估的可接受性和可行性。将在基线、治疗期间和1个月随访时收集焦虑和抑郁、症状负担、健康相关生活质量以及抗焦虑药物使用情况的测量数据。
尽管引导式意象对其他癌症患者群体有效，但尚无关于其用于HNC患者焦虑和抑郁的已发表干预措施。本拟议项目评估了一种有可能减轻弱势群体心理困扰的干预措施的可行性和可接受性。此外，我们将初步研究行为干预对心理困扰和抗焦虑药物使用的影响，这是一个新的研究领域。
Clinicaltrials.gov NCT03662698；于2018年9月6日注册。
