Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00518050
First received: August 15, 2007
Last updated: September 11, 2014
Last verified: September 2014

August 15, 2007
September 11, 2014
October 2006
October 2015   (final data collection date for primary outcome measure)
This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors. [ Time Frame: 2 hours ]
Complete list of historical versions of study NCT00518050 on ClinicalTrials.gov Archive Site
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. [ Time Frame: half an hour ] [ Designated as safety issue: No ]
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. [ Time Frame: half an hour ]
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Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns
Melanoma Survivors: Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Eligible melanoma survivors will be initially identified and screened using the Melanoma DMT Database. We will select a random sample from the database.

  • Melanoma
  • Survivors
  • Psychological Factors
  • 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
  • Behavioral: Survey
    History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors
  • Specific Aim 1- 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
    Intervention: Behavioral: Focus group
  • Specific Aim 2- Survey Study
    A separate random sample of melanoma survivors will complete the pilot questionnaire. To enhance completion rates, survey instruments will be developed to be both self-administered and interviewer-administered. The survey will include questions from existing surveys, regarding demographics, sun sensitivity, eye and hair color, color of untanned skin, sun exposure, skin selfexamination, sun protection practices and frequency of sunburns, psychosocial/cognitive factors: skin cancer knowledge, skin awareness, cancer worry, perceived risk of recurrence, cancer risk and screening behaviors, and access to health care and insurance.
    Intervention: Behavioral: Survey
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
348
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00518050
06-128
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Susan Oliveria, ScD, MPH Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP