Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns

Melanoma Clinical Trial

Official title:

Melanoma Survivors: Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518050
• Other study ID #: 06-128
• Status: Completed
• Phase: N/A
• First received: August 15, 2007
• Last updated: July 15, 2015
• Start date: October 2006
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• 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 health behaviors of melanoma survivors. We want to know about their thoughts and concerns. Melanoma is a type of skin cancer. The number of people being diagnosed with melanoma is growing. Many people who are diagnosed with melanoma are young. Little research has been done to find out how melanoma survivors feel years after they have been treated.

Description:

The rapidly rising incidence and mortality rates of melanoma, the most fatal form of skin cancer, are among the greatest increases of all preventable cancers over the past decade. However, because of recent advances in early detection, secondary prevention efforts, and treatment, the number of melanoma survivors is increasing. Little research has been conducted on melanoma survivors and important opportunities exist for research in this understudied population. Understanding recurrence and second primary cancer risk, cognitive characteristics, behaviors, surveillance patterns, economic sequelae, and family issues of melanoma survivors is imperative from a public health standpoint to promote the health and well-being of this cohort. The objectives of this study are to: 1) conduct focus groups to enhance our understanding of the behaviors of melanoma survivors, and 2) conduct a pilot survey study based on the results of the focus groups to further describe the behavioral and psychosocial issues in melanoma survivors. This will be among the first studies that explores behavioral and psychosocial issues in melanoma survivors. The study findings will inform a large-scale melanoma survivorship grant proposal to the National Cancer Institute or other federal/private sources of funding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For the focus group recruitment (Specific Aim 1) - Patients with melanoma (invasive primary cutaneous melanoma, stages 1-III), who have been treated at MSKCC from 1996-2005

For the survey group recruitment (Specific Aim 2):

patients with melanoma (invasive primary cutaneous melanoma, stages 1-III), who have been treated at MSKCC from 2001-2011• Ability to sign informed consent which indicates the psychosocial, behavioral, epidemiological nature of this study

• Age = or = to 18 years and fluent in the English language

Exclusion Criteria:

• Patients with intraepithelial (in situ) melanoma

• Patients with stage IV melanoma

• Patients with nodal or visceral melanoma without a documented primary lesion

• Patients with prior malignancies For the focus group recruitment (Specific Aim 1): (patients treated at MSKCC from 1996-2005) who have a diagnosis >10 years ago from treatment. For the survey group recruitment (Specific Aim 2): patients treated at MSKCC from 2001-2011)who have a diagnosis >10 years ago from treatment.

• Patients with a recent diagnosis of melanoma, <12 months

• Patients who are one year or more post diagnosis and are still receiving treatment for their melanoma

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Melanoma
• Psychological Factors
• Survivors

Intervention

Behavioral:
• Focus group
Conduct focus groups in melanoma survivors to enhance the understanding of the behavioral aspects of: Screening, skin self-examination, sun protection, and other cancer preventive practices; Cognitive factors (knowledge, awareness, melanoma worry, and perceived risk) related to screening and sun protection practices; and, Impact of melanoma on quality of life, family relationships, and economic issues arising from treatment
• Survey
History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center 1275 York Avenue	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	This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors.		2 hours	No
Secondary	Conduct a pilot survey study of melanoma survivors to describe the behavioral and psychosocial issues in melanoma survivors. Results from the survey will enable us to obtain preliminary data in order to conduct a larger scale study.		half an hour	No

External Links

•   Memorial Sloan Kettering Cancer Center