Reducing Skin Cancer Risk in Childhood Cancer Survivors
Primary Purpose
Skin Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient activation and education (PAE)
PAE plus physician activation (PAE + MD)
PAE physician activation, plus teledermoscopy (PAE +MD +TD)
Sponsored by
About this trial
This is an interventional screening trial for Skin Neoplasms focused on measuring Skin neoplasms, Radiation, Screening, Self-examination, Comparative effectiveness research, Dermoscopy
Eligibility Criteria
Inclusion Criteria:
- treated with radiation for a childhood cancer
- have a regular healthcare provider whom he/she has seen in the previous 2 years, or plans to see in the next year
- have a phone that can receive text messages
- have access to a dermlite compatible smartphone or tablet
Exclusion Criteria:
- personal history of a skin cancer diagnosis
Sites / Locations
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Patient activation and education
PAE plus physician activation
PAE, MD, plus teledermoscopy
Arm Description
Patient activation and education (PAE)
PAE plus physician activation (PAE + MD)
PAE physician activation, plus teledermoscopy (PAE +MD +TD)
Outcomes
Primary Outcome Measures
Patient thorough skin self-examination (TSSE)
Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 2 months prior to the 18-month follow-up assessment.
Secondary Outcome Measures
Completion of a physician skin exam
Completion of a physician skin exam will be assessed by participant report and chart review.
Shorter time interval to diagnostic visit
A shorter time interval between the first finding of a suspect lesion after randomization and a diagnostic visit will be assessed by participant report and chart review.
Full Information
NCT ID
NCT02046811
First Posted
January 22, 2014
Last Updated
June 19, 2018
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
National Cancer Institute (NCI), St. Jude Children's Research Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Emory University
1. Study Identification
Unique Protocol Identification Number
NCT02046811
Brief Title
Reducing Skin Cancer Risk in Childhood Cancer Survivors
Official Title
Reducing Skin Cancer Risk in Childhood Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
National Cancer Institute (NCI), St. Jude Children's Research Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. This randomized controlled trial uses a three-group design.
Our specific aims are to: (1) Determine the impact of a Patient Activation and Education intervention with and without physician activation and teledermatology on skin cancer early detection practices, (2) Determine the impact of the intervention on time to diagnosis, and (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.
Detailed Description
There are currently more than 420,000 Americans who are long-term survivors of childhood and adolescent cancer. While these groups have greatly benefited from recent medical advances, primarily increasing overall survival rates, treatment advances have come at a cost. It is now clear that childhood radiation therapy has caused survivors to be at extremely high risk for non-melanoma skin cancer (NMSC) and increased risk of melanoma. Early detection is crucial to reduce the morbidity caused by NMSCs and the morbidity and mortality incurred due to melanoma. Both patient and provider action are needed to detect and treat early skin cancers and to find new solutions to ensure expedited follow-up care and treatment, especially among those who live where they have little access to dermatologists.
The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. All participants will receive text messages encouraging them to examine their skin and request physician examinations while concurrently driving them to a study website that provides education related to the associated skills, and reinforces and expands the text messages. To reduce skin cancers among this young and dispersed patient population, this study will address several key issues: (1) how to provide patients with the skills needed to conduct effective skin self-examinations; 2) how to prompt action from patient's physicians when worrisome moles and lesions are found; and 3) how to ensure rapid access to dermatologic exams, which in some parts of the US can take weeks or months to schedule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Neoplasms
Keywords
Skin neoplasms, Radiation, Screening, Self-examination, Comparative effectiveness research, Dermoscopy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
726 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient activation and education
Arm Type
Experimental
Arm Description
Patient activation and education (PAE)
Arm Title
PAE plus physician activation
Arm Type
Experimental
Arm Description
PAE plus physician activation (PAE + MD)
Arm Title
PAE, MD, plus teledermoscopy
Arm Type
Experimental
Arm Description
PAE physician activation, plus teledermoscopy (PAE +MD +TD)
Intervention Type
Behavioral
Intervention Name(s)
Patient activation and education (PAE)
Intervention Description
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)
Intervention Type
Behavioral
Intervention Name(s)
PAE plus physician activation (PAE + MD)
Intervention Description
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients
Intervention Type
Behavioral
Intervention Name(s)
PAE physician activation, plus teledermoscopy (PAE +MD +TD)
Intervention Description
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients, and participant receipt of a dermoscopic lens
Primary Outcome Measure Information:
Title
Patient thorough skin self-examination (TSSE)
Description
Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 2 months prior to the 18-month follow-up assessment.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Completion of a physician skin exam
Description
Completion of a physician skin exam will be assessed by participant report and chart review.
Time Frame
18 months
Title
Shorter time interval to diagnostic visit
Description
A shorter time interval between the first finding of a suspect lesion after randomization and a diagnostic visit will be assessed by participant report and chart review.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
treated with radiation for a childhood cancer
have a regular healthcare provider whom he/she has seen in the previous 2 years, or plans to see in the next year
have a phone that can receive text messages
have access to a dermlite compatible smartphone or tablet
Exclusion Criteria:
personal history of a skin cancer diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Geller, RN, MPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25873142
Citation
Daniel CL, Armstrong GT, Keske RR, Davine JA, McDonald AJ, Sprunck-Harrild KM, Coleman C, Haneuse SJ, Mertens AC, Emmons KM, Marghoob AA, Elkin EB, Dusza SW, Robison LL, Geller AC. Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial. Trials. 2015 Mar 24;16:109. doi: 10.1186/s13063-015-0637-x.
Results Reference
derived
Learn more about this trial
Reducing Skin Cancer Risk in Childhood Cancer Survivors
We'll reach out to this number within 24 hrs