Clinical trial NCT00518050: Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns
Official title: Melanoma Survivors: Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Survivors
Psychological Factors
Keywords: Health Behaviors
Surveillance
06-128
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-08-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible melanoma survivors will be initially identified and screened using the Melanoma DMT Database. We will select a random sample from the database.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors.
timeFrame: 2 hours
Secondary outcomes:
measure: 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.
timeFrame: half an hour
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center 1275 York Avenue
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Susan Oliveria, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: