NCT01018004

Brief Summary

RATIONALE: Gathering information over time from follow-up visits may help doctors plan the best follow-up schedule. It is not yet known which follow-up schedule is more effective in improving patient quality of life. PURPOSE: This randomized clinical trial is comparing follow-up schedules to see how well they work in patients with newly diagnosed stage IB or stage II melanoma.

Trial Health

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Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

August 26, 2013

Status Verified

July 1, 2010

Enrollment Period

5.8 years

First QC Date

November 20, 2009

Last Update Submit

August 23, 2013

Conditions

Melanoma (Skin)

Keywords

stage IB melanomastage II melanoma

Outcome Measures

Primary Outcomes (1)

  • Patient well-being expressed in 4 questionnaires

Secondary Outcomes (4)

  • Occurrence and type of recurrence (locoregional versus distant metastases) that develop

  • Person detecting the recurrences and the exact way of detection

  • Progress of recurrent disease and consequences for its treatment

  • Well-being of patients per group and of recurred patients

Interventions

follow-up careOTHER
questionnaire administrationOTHER
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Pathologically confirmed newly diagnosed cutaneous melanoma * AJCC stage IB or II disease * Received curative treatment * Completed the first set of questionnaires PATIENT CHARACTERISTICS: * Able to speak and understand Dutch or English * Must be able to participate in the follow-up schedule (e.g., permanently living in the Netherlands) * No known second malignancy PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Medisch Centrum Leeuwarden - Zuid

Leeuwarden, 8934 AD, Netherlands

RECRUITING

Isala Klinieken - locatie Weezenlanden

Zwolle, NL-8000 GM, Netherlands

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Aftercare

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Continuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Harald J. Hoekstra, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

March 1, 2006

Primary Completion

December 1, 2011

Last Updated

August 26, 2013

Record last verified: 2010-07

Locations

NL(4)