- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00518050
Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns
Melanoma Survivors: Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center 1275 York Avenue
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Specific Aim 1- Focus Group
Conduct focus groups in melanoma survivors to enhance the understanding of the behavioral aspects of:
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Conduct focus groups in melanoma survivors to enhance the understanding of the behavioral aspects of:
|
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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.
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History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors.
Time Frame: 2 hours
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2 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
half an hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan Oliveria, ScD, MPH, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-128
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