Trial record 1 of 280 for:    "Skin Neoplasms"
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Reducing Skin Cancer Risk in Childhood Cancer Survivors

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
St. Jude Children's Research Hospital
Dana-Farber Cancer Institute
Memorial Sloan-Kettering Cancer Center
Emory University
Information provided by (Responsible Party):
Alan Geller, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT02046811
First received: January 22, 2014
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Skin Neoplasms
Behavioral: Patient activation and education (PAE)
Behavioral: PAE plus physician activation (PAE + MD)
Behavioral: PAE physician activation, plus teledermoscopy (PAE +MD +TD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Reducing Skin Cancer Risk in Childhood Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Patient thorough skin self-examination (TSSE) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Completion of a physician skin exam will be assessed by participant report and chart review.

  • Shorter time interval to diagnostic visit [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 801
Study Start Date: September 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient activation and education
Patient activation and education (PAE)
Behavioral: Patient activation and education (PAE)
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone app)
Experimental: PAE plus physician activation
PAE plus physician activation (PAE + MD)
Behavioral: PAE plus physician activation (PAE + MD)
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone app), 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
Experimental: PAE, MD, plus teledermoscopy
PAE physician activation, plus teledermoscopy (PAE +MD +TD)
Behavioral: PAE physician activation, plus teledermoscopy (PAE +MD +TD)
Text messaging and web-based tutorials for a 12-month duration (a website and smartphone app), 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

Detailed Description:

There are currently more than 325,000 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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 smart phone and/or a tablet

Exclusion Criteria:

  • personal history of a skin cancer diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02046811

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Harvard School of Public Health
St. Jude Children's Research Hospital
Dana-Farber Cancer Institute
Memorial Sloan-Kettering Cancer Center
Emory University
Investigators
Principal Investigator: Alan Geller, RN, MPH Harvard School of Public Health
  More Information

No publications provided

Responsible Party: Alan Geller, RN, MPH, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02046811     History of Changes
Other Study ID Numbers: 1 R01 CA175231, R01CA175231
Study First Received: January 22, 2014
Last Updated: January 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Harvard School of Public Health:
Skin neoplasms
Radiation
Screening
Self-examination
Comparative effectiveness research
Dermoscopy

Additional relevant MeSH terms:
Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014