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Clinical Trials/NCT00416988
NCT00416988
Completed
Not Applicable

Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence

Rhode Island Hospital0 sites1,135 target enrollmentDecember 28, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Melanoma (Skin)
Sponsor
Rhode Island Hospital
Enrollment
1135
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 28, 2006
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

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