NCT00518050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

8.8 years

First QC Date

August 15, 2007

Last Update Submit

July 15, 2015

Conditions

Keywords

Health BehaviorsSurveillance06-128

Outcome Measures

Primary Outcomes (1)

  • This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors.

    2 hours

Secondary Outcomes (1)

  • 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.

    half an hour

Study Arms (2)

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

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

Interventions

Focus groupBEHAVIORAL

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 1- Focus Group
SurveyBEHAVIORAL

History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors

Specific Aim 2- Survey Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center 1275 York Avenue

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

MelanomaHealth Behavior

Interventions

Focus GroupsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Susan Oliveria, ScD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 17, 2007

Study Start

October 1, 2006

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations