Loading clinical trials...
Loading clinical trials...
Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
RATIONALE: An educational program may be effective in increasing monthly skin self-examinations to detect melanoma in healthy participants. PURPOSE: This randomized clinical trial is studying how well an educational program works in increasing monthly skin self-examinations to detect melanoma in healthy participants.
OBJECTIVES: * Determine the incidence of monthly thorough skin self-examinations (TSE) for early detection of melanoma in healthy participants who are under routine care by their primary care physician. * Determine the impact of the intervention package and the resulting change in TSE performance, in terms of visits to healthcare providers for skin problems, in these participants. * Evaluate the efficacy of this intervention package in improving performance of TSE in these participants. * Estimate potential effect of this intervention on health care resource use. OUTLINE: This is a controlled, randomized study. Two weeks prior to their appointment with their physician, participants undergo a baseline assessment. During the appointment, participants are randomized to 1 of 2 intervention arms. * Arm I (control): Participants receive written educational materials and watch a video on healthy dietary habits during their appointment. They receive nutrition tip sheets, including information related to reducing fat, saturated fat, and cholesterol in the diet, at 2 and 6 months after their initial appointment. Participants also undergo telephone assessments at 2, 6, and 12 months after their initial appointment. * Arm II (skin self-examinations): Participants undergo a 10- to 15-minute face-to-face counseling session with the study intervention specialist and receive training in thorough skin self-examination (TSE) directly after their appointment. They also receive written educational materials and watch a 25-minute video designed to motivate and teach them to do TSE. Two weeks later, participants receive a follow-up call from the same study intervention specialist. Participants receive tailored feedback at 2 and 6 months and a motivational postcard at 4 months after their initial appointment. Participants also undergo telephone assessments as in arm I. Participating physicians seeing participants in both arms attend a 60-minute educational session regarding skin cancer detection, prevention, identification, and triage, supplemented by written materials. They are also trained and prompted to deliver a 30-second message emphasizing the desirability of performing monthly TSE during their appointment with participants. After completion of the study intervention, participants are offered the educational materials of the intervention arm to which they were not randomized. PROJECTED ACCRUAL: A total of 1,135 participants will be accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Last Updated
June 20, 2013
1,135
ESTIMATED participants
educational intervention
OTHER
Lead Sponsor
Rhode Island Hospital
Collaborators
NCT04079166
NCT04911998
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions