Buddy Relationships in DermatoloGic Excisions for Skin Cancer

Quality of Life Clinical Trial

— BRIDGES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036344
• Other study ID #: 831704
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: August 27, 2019

Study information

• Verified date: March 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 27, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peer Mentorship
• Quality of Life
• Skin Cancer Face
• Skin Neoplasms
• Surgical Wound

Intervention

Behavioral:
• Peer Mentorship Program
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.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (7)

Badger K, Royse D. Adult burn survivors' views of peer support: a qualitative study. Soc Work Health Care. 2010;49(4):299-313. doi: 10.1080/00981380903493095. — View Citation

Guy GP Jr, Machlin SR, Ekwueme DU, Yabroff KR. Prevalence and costs of skin cancer treatment in the U.S., 2002-2006 and 2007-2011. Am J Prev Med. 2015 Feb;48(2):183-187. doi: 10.1016/j.amepre.2014.08.036. Epub 2014 Nov 10. — View Citation

Meyer A, Coroiu A, Korner A. One-to-one peer support in cancer care: a review of scholarship published between 2007 and 2014. Eur J Cancer Care (Engl). 2015 May;24(3):299-312. doi: 10.1111/ecc.12273. Epub 2014 Dec 16. Review. — View Citation

Pearl RL, Shao K, Shin TM, Miller CJ, Sobanko JF. Acute Appearance Concerns in Patients Undergoing Mohs Surgery: A Single-Institution Cross-Sectional Study. Dermatol Surg. 2018 Oct;44(10):1349-1351. doi: 10.1097/DSS.0000000000001431. — View Citation

Sobanko JF, Sarwer DB, Zvargulis Z, Miller CJ. Importance of physical appearance in patients with skin cancer. Dermatol Surg. 2015 Feb;41(2):183-8. doi: 10.1097/DSS.0000000000000253. Review. — View Citation

Sobanko JF, Zhang J, Margolis DJ, Etzkorn JR, Shin TM, Sarwer DB, Miller CJ. Patient-reported quality of life and psychosocial health prior to skin cancer treatment - A cross-sectional study. J Am Acad Dermatol. 2016 Jul;75(1):217-218.e2. doi: 10.1016/j.jaad.2016.01.033. — View Citation

Zhang J, Miller CJ, O'Malley V, Etzkorn JR, Shin TM, Sobanko JF. Patient quality of life fluctuates before and after Mohs micrographic surgery: A longitudinal assessment of the patient experience. J Am Acad Dermatol. 2018 Jun;78(6):1060-1067. doi: 10.1016/j.jaad.2018.02.065. Epub 2018 Mar 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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