Research study to learn more about the potential benefits and challenges of a new supportive care program for people affected by melanoma.

Not Applicable

Active, not recruiting

• Conditions: Melanoma; Cancer - Malignant melanoma; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12613000304730
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Participants will be eligible for the study if they meet all of the following criteria:
a. Previously diagnosed with melanoma stage 0, I or II;
b. At high risk of developing new primary melanoma (attending a high risk clinic);
c. Able to give informed consent for the study;
d. Possess sufficient English language skills to read the booklet and complete the study questionnaires without an aide; and
e. Aged 18 years or older.

Exclusion Criteria

Individuals will not be eligible to take part if they meet any one of the following criteria:
*Current stage III or IV (metastatic) melanoma, as research suggests that these patients may have different psychosocial needs to stage I/II patients (where the melanoma has been confined to a primary tumour only);
*At high risk of melanoma but have never had the disease (e.g. people without melanoma who carry a high penetrance genetic mutation);
*Have a known past or current diagnosis of severe major depression, active psychotic illness, or other serious psychiatric condition or cognitive deficit (e.g. dementia).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fear of Cancer Recurrence: will be assessed using a modified (i.e. melanoma-specific) version the 43-item Fear of Cancer Recurrence Inventory (FCRI).[- At baseline (6 weeks before their high risk clinic appointment) (T0).<br>- At 4 weeks after their high risk clinic appointment (T1).<br>- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).<br>- At 12 months conditional to effectiveness at 6 months later (T3).]