Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns
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| First Received Date ICMJE | August 15, 2007 | ||||||||
| Last Updated Date | April 11, 2013 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors. [ Time Frame: 2 hours ] | ||||||||
| Change History | Complete list of historical versions of study NCT00518050 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns | ||||||||
| Official Title ICMJE | Melanoma Survivors: Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 348 | ||||||||
| Estimated Completion Date | October 2014 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00518050 | ||||||||
| Other Study ID Numbers ICMJE | 06-128 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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