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临床试验/NCT04036344
NCT04036344已完成不适用

Buddy Relationships in DermatoloGic Excisions for Skin Cancer ("BRIDGES"): A Trial of One-to-one Peer Support in Patients With Facial Skin Cancers Treated With Mohs Surgery

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Skin Cancer Index (SCI) scores

研究概览

简要总结

More than 5 million skin cancer surgeries are performed each year in the United States with 80% of tumors appearing on the head and neck. Facial skin cancer diagnosis negatively affects patient quality of life (QOL) and treatment of skin cancer creates visible scars early in the postoperative period, increases anxiety, and impairs social interactions. We believe that these negative psychosocial changes represent an unmet need for additional social support and practical guidance. A one-to-one peer support program designed for skin cancer patients could provide a focused, cost-effective, patient-centered intervention to improve quality of life and increase satisfaction. Comparable one-to-one peer support programs have demonstrated high rates of patient satisfaction and positive QOL outcomes in a wide range of conditions. This prospective peer support program would be the first of its kind for melanoma and keratinocytic skin cancers. Our pilot program was designed in consultation with leading peer mentorship program researchers and we will implement a structured system to match volunteer mentors with patients. Through qualitative and quantitative data, we will evaluate the program's effect on patient QOL at 3 separate intervals: at initial consultation, 1-2 weeks post-surgery, and 3 months post-surgery. We hope that this study will enable us to design and execute a larger multi-center clinical trial in order to establish a best practice for surgeons to usher patients through the postoperative healing process after skin cancer surgery.

详细描述

Skin cancer is a common, often chronic condition that negatively impacts patient quality of life. Currently, more than 5 million skin cancer surgeries are performed in the United States each year, at a cost of over $8 billion per year. Eighty percent of these tumors occur on the head and neck, anatomic sites most visible to society. Recent studies have demonstrated that patients have reduced concern about the severity and prognosis of their skin cancer in the period immediately following Mohs micrographic surgery (MMS). However, patient QOL related to appearance and social interactions is impaired in the weeks following MMS due to elevated distress regarding post-surgical physical appearance.

One-to-one peer support programs benefit both the patient and the mentor. In one-to-one peer support programs, individuals previously affected by a disease or condition volunteer to provide support to current patients in a loosely structured, mentorship setting. Peer mentors provide mentees with social and emotional support as well as practical guidance on health system navigation. Similar peer mentorship programs with burn patients who had significant changes to outward physical appearance resulted in positive experiences for both mentee and mentor. Notable mentee feedback included the formation of an immediate connection with a peer supporter and feelings of "automatic trust" even after previously seeing a mental health professional for their care. Mentors described their participation in peer programs as a source for continued learning and inspiration for their own recovery.

One-to-one peer support is a cost-effective, well-received intervention that increases patient satisfaction and objective QOL measures across many fields. Outcome measurements of one-to-one peer mentorship programs have demonstrated high rates of patient satisfaction and positive psychological outcomes in patients suffering from diabetes, breast cancer, prostate cancer, colon cancer, and gynecologic cancers. The operating cost of peer support mentorship is low, and these programs can further relieve the health care system by reallocating access to patient support services to a community level.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible candidates will be English-speaking adults with non-metastatic facial skin cancers.

排除标准

  • Candidates with severe symptoms of mood, anxiety, or substance use at time of recruitment screening. Participants who require interdisciplinary collaboration (e.g. MMS + plastic surgery, ENT, etc.) for treatment of their facial skin cancer.

结局指标

主要结局

Skin Cancer Index (SCI) scores

时间窗: 3-month postoperative follow-up

Primary study measures include patient responses from the Skin Cancer Index (SCI), a disease-specific, 15-question validated QOL instrument. The SCI is divided into 3 subscales: appearance, emotion, and social domains. Higher scores indicate increased QOL.

次要结局

  • Qualitative participant feedback(3-month postoperative follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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