Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
- 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
- Evaluate the efficacy of this intervention package in improving performance of TSE in
- 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
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.
Allocation: Randomized, Primary Purpose: Prevention
Martin A. Weinstock, MD, PhD
Rhode Island Hospital
United States: Federal Government