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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.
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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
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Secondary ID [1]
282119
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NIL
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Universal Trial Number (UTN)
U1111-1140-5676
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
288649
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Condition category
Condition code
Cancer
288947
288947
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0
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Malignant melanoma
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Mental Health
288990
288990
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0
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Anxiety
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Mental Health
288991
288991
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0
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286723
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Rehabilitation
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Intervention code [2]
286724
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Behaviour
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Comparator / control treatment
Participants allocated to the control arm will receive:
1.Cancer Council booklet “Understanding melanoma” and
2.A blank notebook
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Control group
Active
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Outcomes
Primary outcome [1]
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Fear of Cancer Recurrence: will be assessed using a modified (i.e. melanoma-specific) version the 43-item Fear of Cancer Recurrence Inventory (FCRI).
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Assessment method [1]
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Timepoint [1]
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- 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).
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Secondary outcome [1]
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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
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Assessment method [1]
301696
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Timepoint [1]
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- 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).
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Secondary outcome [2]
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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).
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Assessment method [2]
301821
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Timepoint [2]
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- 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).
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Secondary outcome [3]
301822
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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.
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Assessment method [3]
301822
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Timepoint [3]
301822
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- 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).
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Secondary outcome [4]
301823
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Melanoma-related knowledge will be assessed using our newly developed melanoma know ledge scale.
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Assessment method [4]
301823
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Timepoint [4]
301823
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- 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).
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Secondary outcome [5]
301824
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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.
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Assessment method [5]
301824
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Timepoint [5]
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- 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).
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Secondary outcome [6]
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Satisfaction with clinical care: Doctor-patient communication will be measured using the Consultation Satisfaction Questionnaire (CSQ).
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Assessment method [6]
301825
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Timepoint [6]
301825
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- 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).
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Secondary outcome [7]
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Unmet information and support needs: Unmet information and support needs will be assess using the Cancer Survivors’ Unmet Needs (CaSUN) questionnaire.
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Assessment method [7]
301826
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Timepoint [7]
301826
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- 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).
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/05/2013
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Actual
18/02/2014
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Date of last participant enrolment
Anticipated
30/11/2014
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Actual
8/12/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
154
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Accrual to date
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Final
164
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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The Poche Centre, Melanoma Institute Australia - North Sydney
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Recruitment postcode(s) [1]
9341
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2290 - Charlestown
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Recruitment postcode(s) [2]
9342
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2050 - Camperdown
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Recruitment postcode(s) [3]
9343
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2060 - North Sydney
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Funding & Sponsors
Funding source category [1]
286885
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Charities/Societies/Foundations
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Name [1]
286885
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Beyond Blue
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Address [1]
286885
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PO Box 6100
Hawthorn West VIC 3122
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Country [1]
286885
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Australia
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Funding source category [2]
286886
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Government body
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Name [2]
286886
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Cancer Institute NSW
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Address [2]
286886
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Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
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Country [2]
286886
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Australia
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Funding source category [3]
286887
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Charities/Societies/Foundations
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Name [3]
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Sydney Catalyst Translational Cancer Research
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Address [3]
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Level 2, 6-10 Mallett Street
Camperdown
NSW 2050
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Country [3]
286887
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
University of Sydney
Research Office, Jane Foss Russell Building (G02), University of Sydney NSW 2006
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Cancer Epidemiology and Services Research (CESR)
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Address [1]
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The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
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Country [1]
285675
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Local Health District (RPAH zone)
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Ethics committee address [1]
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Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
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Ethics committee country [1]
288946
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Australia
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Date submitted for ethics approval [1]
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27/02/2013
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Approval date [1]
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13/03/2013
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Ethics approval number [1]
288946
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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.
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Trial website
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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.
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Public notes
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Contacts
Principal investigator
Name
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Dr Anne Cust
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Address
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Cancer Epidemiology and Services Research
The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
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Country
38462
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Australia
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Phone
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+61 2 8627 1565
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Miss Mbathio Dieng
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Address
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Cancer Epidemiology and Services Research
The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
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Country
38463
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Australia
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Phone
38463
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+61 2 8627 1538
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Fax
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Email
38463
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[email protected]
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Contact person for scientific queries
Name
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Dr Anne Cust
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Address
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Cancer Epidemiology and Services Research
The Lifehouse, Level 6 North,
119-143 Missenden Road
Camperdown NSW 2050
Australia
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Country
38464
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Australia
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Phone
38464
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+61 2 8627 1565
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Fax
38464
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Email
38464
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Benefits of a brief psychological intervention targeting fear of cancer recurrence in people at high risk of developing another melanoma: 12-month follow-up results of a randomized controlled trial.
2020
https://dx.doi.org/10.1111/bjd.17990
Embase
Sensitivity of preference-based quality-of-life measures for economic evaluations in early-stage Melanoma.
2018
https://dx.doi.org/10.1001/jamadermatol.2017.4701
Embase
Psychoeducational intervention for people at high risk of developing another melanoma: A pilot randomised controlled trial.
2017
https://dx.doi.org/10.1136/bmjopen-2016-015195
N.B. These documents automatically identified may not have been verified by the study sponsor.
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