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

18 Years
Not Enrolling
Melanoma (Skin), Weight Changes

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Trial Information

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
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

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.

Inclusion Criteria


- 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

- 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


- 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


- Must not have been previously enrolled on this study

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Martin A. Weinstock, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Rhode Island Hospital


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Weight Changes
  • melanoma
  • weight changes
  • Body Weight Changes
  • Melanoma