None listed
Conditions
Brief summary
The primary aim of our study is to test whether a psycho-educational intervention, comprising a tailored, psycho-educational booklet and individual, telephone-based psychological support, will reduce fear of melanoma recurrence, defined in this study as fear of a previous melanoma coming back somewhere else in the body as well as fear of developing a new melanoma on the skin. The secondary aims of our study are to assess the cost-effectiveness of the psycho-educational intervention, and to improve patient understanding of melanoma risk, doctor-patient communication about melanoma, melanoma-related health behaviours (e.g. skin self-examination) and unmet supportive care needs. Who is it for? To participate in the study, patients will be aged over 18 years, will have a previous melanoma diagnosed at stages 0 I or II, will be attending one of the melanoma high risk clinics in New South Wales, and have sufficient English language skills to read the booklet and complete the study questionnaires. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups – the ‘intervention’ group or the ‘standard care’ group. Four weeks before their full dermatological appointment at the high risk clinic (HRC), participants in the intervention group will receive two booklets: our newly developed psycho-educational booklet (called ‘Melanoma: Questions and answers’), and the freely-available Cancer Council booklet (called ‘Understanding Melanoma’). Participants in the intervention group (Group 1) will then have three individual telephone-based psychological support sessions (each up to 90 minutes duration) with a clinical psychologist. The first telephone session will occur about one week after participants receive the booklets (before their HRC appointment). The second telephone session will occur about one week after participants’ HRC appointment, and the third telephone session will occur about three weeks after participants’’ full HRC appointment. These telephone sessions aim to give participants the opportunity to raise questions or concerns they have after reading the melanoma booklet and after attending their clinical consultation. Their key goals are to assist participants: a) to have a point of contact; b) to use the newly developed melanoma psycho-educational booklet; c) to prioritise their goals; d) to use other available avenues of support Participants in the ‘standard care’ group will receive the Cancer Council ‘Understanding melanoma’ booklet and a blank notepad, four weeks before attending their clinic appointment. All participants will be asked to complete a questionnaire at baseline (6 weeks before their full dermatological consultation at the HRC), 2 weeks after their full dermatological consultation at the HRC, and again at 6 and 12 months, to evaluate the effect of the intervention on fear of melanoma recurrence, anxiety, stress, depression, quality of life, satisfaction with clinical care, melanoma risk knowledge, healthy behavioural adjustment to melanoma risk and unmet supportive care needs.
Interventions
The primary aim of the study is to evaluate in a randomised controlled trial, the efficacy of a psycho-educational intervention in reducing fear of melanoma recurrence (defined in this study as fear of melanoma recurrence as well as fear of developing new primary disease) in melanoma survivors at high risk of developing new primary melanoma, compared to usual care. Participants allocated to the intervention will receive: 1.The newly developed, evidence-based psycho-educational booklet in hardcopy, ‘Melanoma: Questions and Answers’ 2.The freely-available Cancer Council booklet, “Understanding melanoma” and 3.Three individual, telephone-based support sessions facilitated by a psychologist: The three telephone sessions will occur at specific time points, timed according to participants’ HRC appointments: a. Session 1 will take place approximately one week before each participant’s next full dermatological appointment at the HRC. b. Session 2 will occur approximately one week after the HRC appointment. c. Session 3 will occur approximately three weeks after the HRC appointment (i.e. two weeks after Session 2). The telephone sessions are designed to provide patient-specific assistance. Session 1 (up to 90 minutes) features an assessment, including a discussion of each participant’s background (family, work, friendships, …), experience of melanoma and clinical care, other health issues, information and support needs, and their goals and wishes for the intervention. Subsequent sessions (up to 50 minutes each) will focus on exploring each participant’s needs and concerns, utilising appropriate psychological techniques and the booklet, ‘Melanoma: Questions and Answers’. Session 2 will also include exploration of the participants’ experience of Session 1, his or her recent clinical appointment and its outcomes, the clinical care received, and related information and support needs. Session 3 will entail a summary of issues discussed during the previous two sessions, and the participant’s experience of working with a psychologist. Appropriate referrals will also be given for further information and support, as needed. The telephone sessions will be recorded with participants’ permission.
Sponsors
Study design
Eligibility
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).