Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

July 23, 2013 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

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

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female melanoma patients during their regularly scheduled surgical clinic appointment at MSKCC.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
female patients undergoing surgical treatment of cutaneous melanoma within two years of diagnosis and treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: conclusion of study
conclusion of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the impact of illness related distress on QOL in women treated for clinically localized primary cutaneous melanoma.
Time Frame: conclusion of study
conclusion of study

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Mary Sue Brady, MD, Memorial Sloan Kettering Cancer Center

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

Helpful Links

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 Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-096

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.

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