ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2464 for:    melanoma
Previous Study | Return to List | Next Study

Melanoma Perception and Health Literacy in People of Color

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02437305
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : November 3, 2016
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Melanoma
Interventions: Behavioral: ABCDEs of Melanoma Skin Cancer
Behavioral: ABCDEs of Melanoma

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were consecutive patients seen for care at Northwestern Medicine's dermatology clinic in Chicago, IL between May and July 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ABCDEs of Melanoma Skin Cancer

A modified melanoma educational intervention that uses the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature "melanoma skin cancer"; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.

ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color.

ABCDEs of Melanoma

A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.

ABCDEs of Melanoma: Conventional melanoma educational intervention.


Participant Flow:   Overall Study
    ABCDEs of Melanoma Skin Cancer   ABCDEs of Melanoma
STARTED   50   50 
COMPLETED   32   38 
NOT COMPLETED   18   12 
Lost to Follow-up                18                12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ABCDEs of Melanoma Skin Cancer

A modified melanoma educational intervention that uses the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature "melanoma skin cancer"; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.

ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color.

ABCDEs of Melanoma

A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.

ABCDEs of Melanoma: Conventional melanoma educational intervention.

Total Total of all reporting groups

Baseline Measures
   ABCDEs of Melanoma Skin Cancer   ABCDEs of Melanoma   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age, Customized 
[Units: Participants]
     
18-25   3   5   8 
26-50   26   29   55 
51-75   21   14   35 
76+   0   2   2 
Gender 
[Units: Participants]
Count of Participants
     
Female      42  84.0%      43  86.0%      85  85.0% 
Male      8  16.0%      7  14.0%      15  15.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American   39   39   78 
Asian/Pacific Islander   5   6   11 
American Indian and Alaskan Native   0   0   0 
Hispanic   6   5   11 
Education 
[Units: Participants]
     
<12 years   1   1   2 
High school   2   4   6 
Some college/technical school   12   11   23 
College graduate   14   17   31 
Graduate/professional   21   17   38 
Personal history of skin cancer 
[Units: Participants]
     
Yes   1   1   2 
No   49   49   98 
Family history of skin cancer 
[Units: Participants]
     
Yes   1   6   7 
No   49   44   93 
Skin reaction to the sun 
[Units: Participants]
     
Always burn/never tan   3   1   4 
Usually burn/rarely tan   3   1   4 
Rarely burn/usually tan   18   24   42 
Never burn/always tan   17   19   36 
None of these   9   5   14 


  Outcome Measures

1.  Primary:   Number of Participants That Performed Regular Self-Skin Examinations   [ Time Frame: 2 months post-intervention ]

2.  Primary:   Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention   [ Time Frame: 2 months post-intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size and high dropout rate; recruitment from dermatology clinic patients with a majority having college degrees or higher so the study results are less generalizable.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Roopal Kundu
Organization: Northwestern Univeristy
phone: 312-926-4926
e-mail: rkundu@nm.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Roopal Kundu, Northwestern University
ClinicalTrials.gov Identifier: NCT02437305     History of Changes
Other Study ID Numbers: STU00200459
First Submitted: April 16, 2015
First Posted: May 7, 2015
Results First Submitted: September 14, 2016
Results First Posted: November 3, 2016
Last Update Posted: January 27, 2017