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Trial registered on ANZCTR


Registration number
ACTRN12613000304730
Ethics application status
Approved
Date submitted
13/03/2013
Date registered
19/03/2013
Date last updated
25/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Research study to learn more about the potential benefits and challenges of a new supportive care program for people affected by melanoma.
Scientific title
A randomised controlled trial evaluating the effect of a psycho-educational intervention on fear of cancer recurrence in melanoma survivors at high risk of developing new primary disease
Secondary ID [1] 282119 0
NIL
Universal Trial Number (UTN)
U1111-1140-5676
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 288649 0
Condition category
Condition code
Cancer 288947 288947 0 0
Malignant melanoma
Mental Health 288990 288990 0 0
Anxiety
Mental Health 288991 288991 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286723 0
Rehabilitation
Intervention code [2] 286724 0
Behaviour
Comparator / control treatment
Participants allocated to the control arm will receive:
1.Cancer Council booklet “Understanding melanoma” and
2.A blank notebook
Control group
Active

Outcomes
Primary outcome [1] 289073 0
Fear of Cancer Recurrence: will be assessed using a modified (i.e. melanoma-specific) version the 43-item Fear of Cancer Recurrence Inventory (FCRI).
Timepoint [1] 289073 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).
Secondary outcome [1] 301696 0
Economic outcomes regarding access to external psychological support or any other service, complementary therapies and medication used. This will be assess using Medicare Benefits Schedule and Pharmaceutical Benefits Scheme databases and a self-report questions regarding use of resources not covered by the MBS and PBS database
Timepoint [1] 301696 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).
Secondary outcome [2] 301821 0
General anxiety, stress and depression: Anxiety, stress and depression will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21).
Timepoint [2] 301821 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).
Secondary outcome [3] 301822 0
Quality of life: Quality of Life (QoL) will be assessed using two measures: The Functional Assessment of Cancer Therapy (FACT-M) and the AQoL-8D.
Timepoint [3] 301822 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).
Secondary outcome [4] 301823 0
Melanoma-related knowledge will be assessed using our newly developed melanoma know ledge scale.
Timepoint [4] 301823 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).
Secondary outcome [5] 301824 0
Healthy behavioural adjustment to melanoma risk (Sun exposure, Sun protection behaviours and Engagement in skin self-examination) will be assessed using The Sun Protection Habits Scale and the Manne scale.
Timepoint [5] 301824 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).
Secondary outcome [6] 301825 0
Satisfaction with clinical care: Doctor-patient communication will be measured using the Consultation Satisfaction Questionnaire (CSQ).
Timepoint [6] 301825 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).
Secondary outcome [7] 301826 0
Unmet information and support needs: Unmet information and support needs will be assess using the Cancer Survivors’ Unmet Needs (CaSUN) questionnaire.
Timepoint [7] 301826 0
- At baseline (6 weeks before their high risk clinic appointment) (T0).
- At 4 weeks after their high risk clinic appointment (T1).
- At 6 months (1 week after their subsequent full high risk clinic appointment ) (T2).
- At 12 months conditional to effectiveness at 6 months later (T3).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be performed using the telephone randomisation service at the NHMRC Clinical Trials Centre, The University of Sydney.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers will be used to generate the sequence in which participants will be randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Linear mixed models will be used to analyse the data to account for the repeated measures (and therefore non-independent) data collected from patients.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 736 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 3539 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 9341 0
2290 - Charlestown
Recruitment postcode(s) [2] 9342 0
2050 - Camperdown
Recruitment postcode(s) [3] 9343 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 286885 0
Charities/Societies/Foundations
Name [1] 286885 0
Beyond Blue
Address [1] 286885 0
PO Box 6100
Hawthorn West VIC 3122
Country [1] 286885 0
Australia
Funding source category [2] 286886 0
Government body
Name [2] 286886 0
Cancer Institute NSW
Address [2] 286886 0
Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
Country [2] 286886 0
Australia
Funding source category [3] 286887 0
Charities/Societies/Foundations
Name [3] 286887 0
Sydney Catalyst Translational Cancer Research
Address [3] 286887 0
Level 2, 6-10 Mallett Street
Camperdown
NSW 2050
Country [3] 286887 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
University of Sydney
Research Office, Jane Foss Russell Building (G02), University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 285675 0
Other Collaborative groups
Name [1] 285675 0
Cancer Epidemiology and Services Research (CESR)
Address [1] 285675 0
The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
Country [1] 285675 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288946 0
Sydney Local Health District (RPAH zone)
Ethics committee address [1] 288946 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 288946 0
Australia
Date submitted for ethics approval [1] 288946 0
27/02/2013
Approval date [1] 288946 0
13/03/2013
Ethics approval number [1] 288946 0

Summary
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.
Trial website
Trial related presentations / publications
Dieng M, Mireskandari S, Costa DJ, Butow P, Morton RL, Mann GJ, Menzies SW, Butow, Cust AE, Kasparian NA. Psycho-educational intervention for people at high risk of developing another melanoma: A pilot randomised controlled trial. Best of the Best Orals – supportive care. Clinical Oncology Society of Australia (COSA) 42nd Annual Scientific meeting; 17-19 November 2015, Hobart.

Dieng M, Kasparian NA, Morton RL et al: The Melanoma care study: protocol of a randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease. BMC Psychol 2015, 3(1):23. DOI: 10.1186/s40359-015-0074-3

Dieng M, Kasparian NA, Morton RL, Costa DJ, Mann GJ, Menzies SW, Butow P, Cust AE. A Randomised Controlled Trial of a Psycho-Educational Intervention for Melanoma Survivors at High Risk of Developing New Primary Disease. Psycho-Oncology 2013, 22 (Suppl. 3): 75. (oral) 15th World Congress of Psycho-Oncology, 4-8 November 2013, Rotterdam, The Netherlands.
Public notes

Contacts
Principal investigator
Name 38462 0
Dr Anne Cust
Address 38462 0
Cancer Epidemiology and Services Research
The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
Country 38462 0
Australia
Phone 38462 0
+61 2 8627 1565
Fax 38462 0
Email 38462 0
anne.cust@sydney.edu.au
Contact person for public queries
Name 38463 0
Miss Mbathio Dieng
Address 38463 0
Cancer Epidemiology and Services Research
The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
Country 38463 0
Australia
Phone 38463 0
+61 2 8627 1538
Fax 38463 0
Email 38463 0
mbathio.dieng@sydney.edu.au
Contact person for scientific queries
Name 38464 0
Dr Anne Cust
Address 38464 0
Cancer Epidemiology and Services Research
The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
Country 38464 0
Australia
Phone 38464 0
+61 2 8627 1565
Fax 38464 0
Email 38464 0
anne.cust@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary