Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
研究概览
简要总结
The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual.
详细描述
The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce radiotherapy-related symptoms of anxiety and depression in patients with head and neck cancers relative to treatment as usual. Treatment as usual contains no psychological interventions to aid in distress, however participants will have access to the psychosocial supports at the cancer center available to all patients. Patients will be randomized to either condition, and surveys of their well-being will be conducted throughout the study.
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 (Outcomes Assessor)
盲法说明
Due to study design, it is not possible to blind either participants or investigators to study condition. However, the biostatistician will be blinded to participant group to minimize bias in analyzing the data.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision to sign and date the consent form.
- •Stated willingness to comply with all study procedures and be available for the duration of the study.
- •Be aged 18 -
- •Ability to read and communicate in English.
- •A confirmed malignancy of the head and neck region (including metastases from other primary tumors and cancers of unknown primary.
- •Initiation of RT at the University of Colorado Cancer Center.
- •Psychiatric and cognitive stability as assessed by chart review (i.e., no documented dementia diagnosis or unmanaged psychiatric symptoms) and study personnel (i.e., ability to attend to meeting with study personnel).
- •Ability to meet remotely via internet connection or over the phone.
排除标准
- •Any individual who does not meet the inclusion criteria.
- •Those who are determined, by mental health professionals, to be psychiatrically unstable.
结局指标
主要结局
The Desire for Patients to Want to Use Guided Imagery While Undergoing Radiotherapy: [Feasibility]
时间窗: From baseline to one month post-radiotherapy, up to 12 weeks.
Feasibility of intervention use will be assessed through self-reported use of the GI intervention measured through timeline follow-back.
The Amount of Patients Who Find Using Guided Imagery Beneficial as a Form of Treatment While Undergoing Radiotherapy: [Acceptability]
时间窗: From baseline to one month post-radiotherapy.
Acceptability of the intervention will be assessed through qualitative interviews with intervention participants. The interviews will assess participant experience in the intervention including thoughts about the intervention content and structure of the intervention. Qualitative data regarding acceptability of the intervention will be gathered through one-on-one, standardized open-ended interviews.
次要结局
- Change From Baseline in Hospital Anxiety and Depression Scales (HADS) Score(Baseline and completion of radiotherapy at 7 weeks)
- Change From Baseline in Memorial Symptom Assessment Scale Short Form (MSAS-SF) Score(Baseline and end of radiotherapy at 7 weeks.)
- The Effect Guided Imagery Has on Distress While Undergoing Radiotherapy: [Impact](From baseline to completion of radiotherapy at 7 weeks.)