Building a Renewed ImaGe After Head & Neck Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Body Image Disturbance
研究概览
简要总结
This study will evaluate whether a time-limited cognitive behavioral therapy (CBT) intervention in the post-treatment time period can address body image disturbance (BID) in patients with surgically-treated head and neck cancer (HNC), thereby improving BID and quality of life (QOL).
详细描述
The investigators will complete a single-arm, phase II pilot study of time-limited CBT on BID in patients with surgically-treated HNC. Reliable, validated patient-reported outcome (PRO) measures of BID will be collected before, 1 month and 3 months after the CBT intervention to provide preliminary data on the effectiveness of CBT for BID in patients with surgically-treated HNC, addressing this critical knowledge gap. It is expected that time-limited CBT implemented in the post-treatment period will decrease BID and improve QOL in affected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Pathologic diagnosis of squamous cell carcinoma of the upper aerodigestive tract (oral cavity, oropharynx, hypopharynx, larynx) or cutaneous malignancy of the head and neck (e.g. squamous cell, basal cell, melanoma, etc)
- •Age > 18
- •American Joint Committee on Cancer (AJCC) stages I-IV
- •Curative intent therapy with surgery with or without adjuvant therapy
- •Body Image Scale (BIS) score > 5 up to 1 year post-treatment
排除标准
- •Inability to speak English
- •Known distant metastatic disease
- •Inability or unwillingness of subject or legal guardian/representative to give informed consent
研究组 & 干预措施
CBT (face to face)
Self-limited cognitive behavioral therapy (CBT) delivered via 6 weekly sessions, face-face
Up to one year after completion of treatment, patients with body image disturbance (BID) as determined by a Body Image Scale (BIS) score > 5 will undergo time-limited CBT consisting of 6 weekly sessions. Each session will be guided by the HNC BID module that we develop but customized to each patient's specific concerns. Each session will last ~60 minutes and be conducted one-one with a psychologist. Patients will complete questionnaires prior to CBT and 1 and 3 months after CBT.
干预措施: cognitive behavioral therapy, face to face (Behavioral)
CBT (telemedicine)
Self-limited cognitive behavioral therapy (CBT) delivered via 6 weekly sessions, via tablet-based telemedicine platform
Up to one year after completion of treatment, patients with body image disturbance (BID) as determined by a Body Image Scale (BIS) score > 5 will undergo time-limited CBT consisting of 6 weekly sessions. Each session will be guided by the HNC BID module that we develop but customized to each patient's specific concerns. Each session will last ~60 minutes and be conducted one-one with a psychologist. Patients will complete questionnaires prior to CBT and 1 and 3 months after CBT. To overcome the expected travel distance-related barrier to receipt of CBT, patients will receive the intervention via tablet-based telemedicine delivery platform
干预措施: cognitive behavioral therapy, telemedicine (Behavioral)
结局指标
主要结局
Change in Body Image Disturbance
时间窗: Prior to intervention until 3 months after completion of intervention
Change in body image disturbance will be measured using Body Image Scale (BIS) scores from before and 3 months after intervention. The BIS has been validated in oncology patients and is the most widely used scale for BID in oncology. It is a 10-item measure that is scored on a 4-point Likert scale; higher scores indicate greater body image dissatisfaction. It addresses the affective, cognitive, and emotional aspects of body image. There are no subscales.
次要结局
- Change in Quality of Life(Prior to intervention until 3 months after completion of intervention)
- Change in Body Image Coping Strategies(Prior to intervention until 3 months after completion of intervention)
- Change in Body Image Investment(Prior to intervention until 3 months after completion of intervention.)
研究者
Evan Graboyes
Associate Professor, Department of Otolaryngology
Medical University of South Carolina