Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

NCT00745862 | Completed

• 1 other identifier: 08-096
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Keywords

Skin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To examine the impact of illness related distress on QOL in women treated for clinically localized primary cutaneous melanoma.

  conclusion of study

Study Arms (1)

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

Interventions

questionnaire on-line or if uncomfortable with a computer interface, paper copies will be provided BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Atkinson TM, Noce NS, Hay J, Rafferty BT, Brady MS. Illness-related distress in women with clinically localized cutaneous melanoma. Ann Surg Oncol. 2013 Feb;20(2):675-9. doi: 10.1245/s10434-012-2635-5. Epub 2012 Sep 11.

  PMID: 22965568 DERIVED

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mary Sue Brady, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: September 3, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

US (1)