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, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Melanoma
Survivors
Psychological Factors
Behavioral: Focus group
Behavioral: Survey

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Melanoma Survivors: Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 348
Study Start Date: October 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
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.
Behavioral: Survey
History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518050

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Susan Oliveria, ScD, MPH Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00518050     History of Changes
Other Study ID Numbers: 06-128
Study First Received: August 15, 2007
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Health Behaviors
Surveillance
06-128

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 23, 2014