Reducing Skin Cancer Risk in Childhood Cancer Survivors
2 other identifiers
interventional
726
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJune 20, 2018
June 1, 2018
2.8 years
January 22, 2014
June 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
18 months
Secondary Outcomes (2)
Completion of a physician skin exam
18 months
Shorter time interval to diagnostic visit
18 months
Study Arms (3)
Patient activation and education
EXPERIMENTALPatient activation and education (PAE)
PAE plus physician activation
EXPERIMENTALPAE plus physician activation (PAE + MD)
PAE, MD, plus teledermoscopy
EXPERIMENTALPAE physician activation, plus teledermoscopy (PAE +MD +TD)
Interventions
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- personal history of a skin cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard School of Public Health (HSPH)lead
- National Cancer Institute (NCI)collaborator
- St. Jude Children's Research Hospitalcollaborator
- Dana-Farber Cancer Institutecollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- Emory Universitycollaborator
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Publications (2)
Geller AC, Coroiu A, Keske RR, Haneuse S, Davine JA, Emmons KM, Daniel CL, Gibson TM, McDonald AJ, Robison LL, Mertens AC, Elkin EB, Marghoob A, Armstrong GT. Advancing Survivors Knowledge (ASK Study) of Skin Cancer Surveillance After Childhood Cancer: A Randomized Controlled Trial in the Childhood Cancer Survivor Study. J Clin Oncol. 2023 Apr 20;41(12):2269-2280. doi: 10.1200/JCO.22.00408. Epub 2023 Jan 9.
PMID: 36623247DERIVEDDaniel 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.
PMID: 25873142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Geller, RN, MPH
Harvard School of Public Health (HSPH)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, MPH
Study Record Dates
First Submitted
January 22, 2014
First Posted
January 28, 2014
Study Start
March 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
June 20, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share