Buddy Relationships in DermatoloGic Excisions for Skin Cancer (BRIDGES)

March 3, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
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
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
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.
EXPERIMENTAL: Mentee - Same Day Surgery
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative participant feedback
Time Frame: 3-month postoperative follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 12, 2018

Primary Completion (ACTUAL)

August 27, 2019

Study Completion (ACTUAL)

August 27, 2019

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (ACTUAL)

July 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 831704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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