Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants

June 19, 2013 updated by: Rhode Island Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1135

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Martin A. Weinstock, MD, PhD, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 27, 2006

First Submitted That Met QC Criteria

December 27, 2006

First Posted (Estimate)

December 28, 2006

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000454855
  • RIH-R01-CA78800

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma (Skin)

Clinical Trials on educational intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe