Buddy Relationships in DermatoloGic Excisions for Skin Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Skin Cancer Face, Quality of Life, Surgical Wound, Peer Mentorship

Intervention / Treatment
-----------------
* Behavioral: Peer Mentorship Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible candidates will be English-speaking adults with non-metastatic facial skin cancers. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control participants receive treatment for a facial skin cancer with Mohs micrographic surgery (MMS), however, do not receive a peer mentor. Participants complete 3 online Skin Cancer Index (SCI) surveys at enrollment, 1 week follow-up, and 3 month follow-up. | |
| Experimental: Mentee - Preoperative Consult<br>Mentees are enrolled at preoperative consultation visit and paired with a peer mentor throughout their treatment of a facial cancer with MMS. Participants have regular contact with their mentor and complete 3 online SCI surveys at enrollment, 1 week follow-up, and 3 month follow-up. | Behavioral: Peer Mentorship Program<br>* Mentee participants are paired with a previous MMS patient (Mentor) who is greater than 1 year status post MMS treatment for a facial skin cancer. Mentors and mentees maintain regular contact by telephone, video chat, or in-person meetings throughout the mentee's facial skin cancer treatment with MMS.<br>|
| Experimental: Mentee - Same Day Surgery<br>Mentees are enrolled at same day surgery visit and paired with a peer mentor throughout their treatment of a facial cancer with MMS. Participants have regular contact with their mentor and complete 3 online SCI surveys at enrollment, 1 week follow-up, and 3 month follow-up. | Behavioral: Peer Mentorship Program<br>* Mentee participants are paired with a previous MMS patient (Mentor) who is greater than 1 year status post MMS treatment for a facial skin cancer. Mentors and mentees maintain regular contact by telephone, video chat, or in-person meetings throughout the mentee's facial skin cancer treatment with MMS.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Cancer Index (SCI) scores | 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. | Enrollment | 
| Skin Cancer Index (SCI) scores | 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. | 1-week postoperative follow-up | 
| Skin Cancer Index (SCI) scores | 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. | 3-month postoperative follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative participant feedback | Secondary measures will include a post study exit survey to evaluate participant satisfaction and program feedback via qualitative and quantitative variables. | 3-month postoperative follow-up |