Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01018004
First received: November 20, 2009
Last updated: August 23, 2013
Last verified: July 2010
  Purpose

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.


Condition Intervention
Melanoma (Skin)
Other: follow-up care
Other: questionnaire administration
Procedure: quality-of-life assessment

Study Type: Observational
Official Title: Prospective Randomized Trial for the Evaluation of a Theoretical Follow-Up Schedule in Cutaneous Melanoma Patients, the MELFO-Study.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Patient well-being expressed in 4 questionnaires [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence and type of recurrence (locoregional versus distant metastases) that develop [ Designated as safety issue: No ]
  • Person detecting the recurrences and the exact way of detection [ Designated as safety issue: No ]
  • Progress of recurrent disease and consequences for its treatment [ Designated as safety issue: No ]
  • Well-being of patients per group and of recurred patients [ Designated as safety issue: No ]

Estimated Enrollment: 178
Study Start Date: March 2006
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine the difference between conventional versus experimental follow-up schedules, in terms of patient well-being, expressed health-related quality of life, level of anxiety, and satisfaction with the follow-up schedule in patients with newly diagnosed stage IB or II cutaneous melanoma.
  • To determine the ability of these schedules to detect recurrences and second primary melanomas in these patients.

OUTLINE: Patients are stratified according to AJCC stage (I vs II). Patients are randomized to 1 of 2 follow-up arms.

  • Arm I (experimental follow-up schedule): Patients undergo a thorough history and physical examination periodically for 5 years. Patients are followed up according to the experimental schedule:

    • For stage IB disease: Patients are followed up annually for 5 years.
    • For stage IIA disease: Patients are followed up biannually for years 1 and 2 and annually for years 3, 4, and 5.
    • For stage IIB or IIC disease: Patients are followed up every 4 months during years 1 and 2, every 6 months during year 3, and annually during years 4 and 5.
  • Arm II: (conventional follow-up schedule): Patients undergo a thorough history and physical examination periodically for 5 years. Patients are followed up according to the conventional schedule:

    • For all stage disease: Patients are followed up every 3 months for year 1, every 4 months for year 2, and every 6 months for years 3-5.

In both arms, patient well-being is measured at 0, 6, 12, 24, 36, 48, and 60 months after primary diagnosis, using the following questionnaires: the health-related quality of life questionnaire (RAND-36), the anxiety questionnaire (STAI version DY-1 [state] and DY-2 [trait]), the Cancer Worry Scale, and Follow-up Satisfaction questionnaire, and the self-designed specific questions regarding self-examination and follow-up satisfaction.

All patients are instructed at primary diagnosis and receive the Melanoma-Patient-Education-Package (MPEP), which consists of information on melanoma (KWF folder "melanoma") and additional instruction on self-examination. Data on type of recurrence (locoregional versus distant), the person detecting the recurrence, progression of recurrence at time of detection, the way the recurrence was detected (e.g., self-examination, accidentally, or at follow-up by physical examination or imaging) and information regarding treatment and further follow-up are collected at each follow-up visit and the outcomes are compared in both groups. Outcomes of independent questionnaires are also compared in both groups.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01018004

Locations
Netherlands
Medisch Spectrum Twente Recruiting
Enschede, Netherlands, 7500 KA
Contact: Contact Person    31-53-487-2000      
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Contact Person    31-50-361-2317    h.j.hoekstra@chir.umcg.nl   
Medisch Centrum Leeuwarden - Zuid Recruiting
Leeuwarden, Netherlands, 8934 AD
Contact: Contact Person    31-58-286-6666      
Isala Klinieken - locatie Weezenlanden Recruiting
Zwolle, Netherlands, NL-8000 GM
Contact: Contact Person    31-38-424-2000      
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Harald J. Hoekstra, MD, PhD University Medical Centre Groningen
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01018004     History of Changes
Other Study ID Numbers: CDR0000659310, UMCG-MELFO, EU-20988
Study First Received: November 20, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IB melanoma
stage II melanoma

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 August 21, 2014