Survivorship After Head And Neck Cancer: Validation of Treatment Summary and Survivorship Care Plans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Physician implementation of TSSP
研究概览
简要总结
The aim of the study is to establish the highest level of evidence to evaluate treatment summary and survivorship care plans (TSSPs) by piloting the TSSPs on patients with HNC.
Hypothesis: HNC patients who receive the intervention of the TSSP will have an increased rate of implementation of recommendations for their needs, greater adherence with follow-up schedules, improved quality of life and improved satisfaction with post-treatment care.
Aim 1 (Validation of TSSP): To validate a treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of HNC patients based on the best available evidence.
Approach: In the first phase of the project the investigators will pilot the London Heath Sciences Centre TSSP with head and neck cancer survivors and then have the TSSP extensively reviewed and modified by our multidisciplinary head and neck oncology treatment team.
Aim 2 (Evaluation of TSSP): To evaluate the implementation of a TSSP in survivors of head and neck cancer compared to usual treatment in a randomized fashion to determine whether TSSPs result in improved implementation of recommendations for HNC survivors and improved quality of life and satisfaction.
Approach: In the second phase of the project the investigators will conduct a randomized controlled trial to compare patient reported outcomes in HNC patients who have received the TSSP to patients who have not received the TSSP.
详细描述
Validation of TSSP: The investigators have performed an extensive literature review to create a comprehensive draft TSSP specifically tailored for HNC patients. The investigators will pilot this study among 20 head and neck cancer survivors. Once the investigators have the feedback from the pilot patients, the investigators will conduct a focus group with the members of our head and neck multidisciplinary group to gain input on the TSSP.
Evaluation of TSSP: The investigators will recruit head and neck cancer survivors with curable stage I-IVA head and neck mucosal cancer at a tertiary level cancer center in Ontario. Patients will receive a survivorship care plan (TSSPs) intervention. The intervention will consist of a survivorship care nurse or radiation therapist counseling session coupled with the provision of individualized TSSPs to patients and their health care providers. After a baseline telephone or in-person interview, eligible participants will be provide with the TSSP.
The primary outcome will be physician implementation of TSSP care recommendations over the course of 12 months, assessed by quarterly patient interviews. Secondary outcomes will include adherence to recommended follow-up schedules, quality of life using validated measures and patient satisfaction with care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •18 years or older
- •willing to provide informed consent
- •diagnosis of stage I-IVA head and neck mucosal cancer (larynx, hypopharynx, oral cavity, oropharynx, nasopharynx)
- •last definitive treatment (surgery, chemotherapy, radiotherapy) at least 1 month but no greater than 3 months from enrollment
- •English speaking
排除标准
- •Second concurrent non-cutaneous malignancy
- •metastatic disease
- •clinically apparent cognitive impairment
- •unable or unwilling to complete questionnaires
- •suspected residual disease after treatment completion
结局指标
主要结局
Physician implementation of TSSP
时间窗: 12 months
Physician implementation of treatment summaries and survivorship care plans (TSSP) recommendations over the course of 12 months, assessed by quarterly patient interviews.
次要结局
- Satisfaction with Care and Communication(baseline and 12 months post-treatment)
- KATZ Comorbidity Scale(baseline and 12 months post-treatment)
- Personal Health Questionnaire Depression Scale (PHQ-8)(baseline and 12 months post-treatment)
- Social support survey(baseline and 12 months post-treatment)
- Patient Self-Efficacy (PEPPI)(baseline and 12 months post-treatment)
- 36-Item Short Form Survey Instrument (SF-36)(baseline and 12 months post-treatment)
- Knowledge and Preparedness for Survivorship Scale (PLANS scale)(baseline and 12 months post-treatment)
- Short-Form Patient Satisfaction Questionnaire (PSQ-18)(baseline and 12 months post-treatment)
研究者
Danielle MacNeil
Assistant Professor - Department of Otolaryngology Head & Neck Surgery
Western University, Canada