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

University Medical Center Groningen (UMCG)

Status: Unknown

Conditions: Melanoma (Skin)

Treatments: Other: follow-up care; Other: questionnaire administration; Procedure: quality-of-life assessment

Study type: Observational

Funder types: Other

Identifiers

NCT01018004

UMCG-MELFO

EU-20988

CDR0000659310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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