Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

Melanoma Clinical Trial

Official title:

Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745862
• Other study ID #: 08-096
• Status: Completed
• Phase: N/A
• First received: August 22, 2008
• Last updated: July 23, 2013
• Start date: August 2008
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the experiences and quality of life of women who have been treated for melanoma. By quality of life, we mean how they are feeling about different aspects of their life. In this study, we are especially interested in their feelings about survival, physical appearance and any family concerns. We will administer a series of QOL questionnaires, data sheets with many questions, to get their response to measure their feelings about these issues.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Clinically node-negative primary cutaneous melanoma.

• Patients participating must be female

• Patients must have completed surgical treatment for melanoma at least 10 days ago and less than 2 years at the time of study entry.

Exclusion Criteria:

• Prior history of cancer with the exception of squamous or basal cell carcinoma of the skin.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Intervention

Behavioral:
• questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided
This pilot study will measure illness related distress in female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment. Areas of particular focus will be survival anxiety, family functioning/childbearing concerns, and aesthetic impact of surgery. Patients will complete a one time only set of quality of life assessments these questionnaires will take 30-45 minutes to complete.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure illness related distress regarding survival, family planning and functioning, and aesthetic satisfaction and QOL in post-surgical female patients diagnosed with clinically localized primary cutaneous melanoma.		conclusion of study	No
Secondary	To examine the impact of illness related distress on QOL in women treated for clinically localized primary cutaneous melanoma.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center