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

Primary Purpose

Melanoma (Skin), Weight Changes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
educational intervention
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma (Skin) focused on measuring melanoma, weight changes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 27, 2006
    Last Updated
    June 19, 2013
    Sponsor
    Rhode Island Hospital
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00416988
    Brief Title
    Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants
    Official Title
    Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rhode Island Hospital
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melanoma (Skin), Weight Changes
    Keywords
    melanoma, weight changes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    1135 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    educational intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin A. Weinstock, MD, PhD
    Organizational Affiliation
    Rhode Island Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18406492
    Citation
    Lee KB, Weinstock MA, Risica PM. Components of a successful intervention for monthly skin self-examination for early detection of melanoma: the "Check It Out" trial. J Am Acad Dermatol. 2008 Jun;58(6):1006-12. doi: 10.1016/j.jaad.2008.03.008. Epub 2008 Apr 11.
    Results Reference
    result

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