Partner Assistance in Learning and Performing Skin Self-Examination

This study has been completed.
Sponsor:
Collaborators:
Loyola University
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
June Robinson, Northwestern University
ClinicalTrials.gov Identifier:
NCT01013844
First received: November 11, 2009
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. The patient is randomized to receive the educational intervention either as a solo learner or with the partner.


Condition Intervention
Melanoma
Behavioral: Skin Self Examination Information and ABCDE Rule

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Partner Assistance in Learning and Performing Skin Self-Examination

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Mean Number of Skin Examinations Without Partner Over 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.

  • Mean Number of Skin Examinations With Partner Over 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.

  • Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.


Enrollment: 130
Study Start Date: December 2003
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Solo Learning
Participant learning alone (without partner).
Behavioral: Skin Self Examination Information and ABCDE Rule
Card with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter > or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens.
Active Comparator: Dyadic Learning
Participant and partner learning together.
Behavioral: Skin Self Examination Information and ABCDE Rule
Card with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter > or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Personal or family history of melanoma. If a personal history of melanoma, the patient was treated at least 1 month ago
  • Evidence of dysplastic nevus syndrome or a large number of moles (Greater than 50)
  • Able to see to read a newspaper, can read at an eighth grade level
  • Speaks English
  • 18 to 70 years old with a spouse or cohabitating partner

Exclusion Criteria:

  • Under 18 years of age
  • Patient overburden by other co-morbid diseases such as chronic immunosuppression from organ transplantation
  • Have insufficient vision to to read a newspaper
  • Unable to read English
  • Have insufficient cognitive skills to follow instructions provided at an eighth grade language level
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013844

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Loyola University
Maywood, Illinois, United States, 60153
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Northwestern University
Loyola University
Dartmouth-Hitchcock Medical Center
Investigators
Study Director: Dennis P West, PhD Northwestern University
Principal Investigator: June K Robinson, MD Northwestern University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: June Robinson, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01013844     History of Changes
Other Study ID Numbers: 2003-01
Study First Received: November 11, 2009
Results First Received: December 3, 2010
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
skin self-examination
SSE
melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 21, 2014