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Clinical Trials/NCT00416988
NCT00416988CompletedNot Applicable

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

Rhode Island Hospital0 sites1,135 target enrollmentStarted: December 28, 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,135

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Prevention

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • DISEASE CHARACTERISTICS:
  • Healthy participants who are scheduled for a routine or health maintenance visit with a participating primary care office that meets all of the following criteria:
  • At least 50% of patients are being seen for regular ongoing general medical care
  • Specializes in internal medicine (subspecialties allowed), family medicine, or obstetrics/gynecology
  • Employs at least 2 physicians who meet all of the following requirements:
  • Agree to participate
  • Work full-time, defined as at least 8 sessions per week of 3 or more hours
  • Completed post-graduate training
  • Not a federal employee or full-time hospital-based faculty
  • Have been in practice at least 1 year
  • Not planning on relocating or retiring within the next 3 years
  • PATIENT CHARACTERISTICS:
  • Must be able to read in either English or Spanish
  • Has no household member who has been previously enrolled on this study, including a person who has the same telephone number or address
  • Not in acute discomfort
  • Able to comply with intervention
  • No impairment that would preclude skin self-examination
  • Must be able to view video
  • No illness or disability that would preclude participation in the study interview
  • PRIOR CONCURRENT THERAPY:
  • Must not have been previously enrolled on this study

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other

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