Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000145808
Ethics application status
Approved
Date submitted
4/12/2020
Date registered
12/02/2021
Date last updated
9/02/2023
Date data sharing statement initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing a Stepped Care Model to Address Fear of Cancer Recurrence in Early Stage (0-II) Melanoma Patients - A Pilot Study
Scientific title
Implementing a Stepped Care Model to Address Fear of Cancer Recurrence in Early Stage (0-II) Melanoma Patients - A Pilot Study
Secondary ID [1] 302779 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
PSI (Psychological Support Implementation) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 319724 0
Fear of Cancer Recurrence 319725 0
Condition category
Condition code
Cancer 317656 317656 0 0
Malignant melanoma
Mental Health 317657 317657 0 0
Anxiety
Mental Health 318252 318252 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this pilot-study, we aim to trial the implementation of the Melanoma Care Program into routine practice. The Melanoma Care Program provided a psycho-educational intervention to early-stage high-risk melanoma patients experiencing fear of cancer recurrence (FCR). This intervention included the provision of a psycho-educational booklet titled ‘Melanoma: Questions and Answers’ and three psychotherapeutic telehealth sessions. This intervention significantly reduced patient FCR 12-months post-intervention. We aim to evaluate both the effectiveness and sustainability of implementing FCR screening and the Melanoma Care Program into routine practice at Melanoma Institute Australia and Royal Prince Alfred Hospital.

Early-stage (0-II) melanoma patients who attend either study site will complete FCR screening using the Fear of Cancer Recurrence Inventory 9-item Short-Form between 4-weeks before and 1 week after their upcoming appointment. Based on these screening results, patients will be placed into a stepped-care model, determining the level of intervention they receive. This stepped-care model is outlined below.

Step 1 - No/Low FCR
Patients who score below 13/36 will continue to receive standard care.

Step 2 - Moderate FCR
Patients who score 13-21/36 will continue to receive standard care, as well as the Melanoma: Questions and Answers booklet and three psychotherapeutic telehealth sessions.

Step 3 - Severe FCR
Patients who score above 21/36 will continue to receive standard care, as well as the Melanoma: Questions and Answers booklet and five psychotherapeutic telehealth sessions

Step 4 – Significant co-morbid mental health condition, regardless of FCR score
Patients identified to have a significant co-morbid mental health condition will be referred to a community mental health specialist to better address their needs.

Standard care involves patient education and support as per usual clinical practice. Furthermore, standard care involves offering Melanoma Institute Australia’s ‘Early Melanoma Guide’ booklet to any participant that do not already possess one. This booklet provides patients with information on diagnosis, treatments and common questions, and is provided to patients at Melanoma Institute Australia as a part of standard practice.

The ‘Melanoma: Questions and Answers’ booklet in the Melanoma Care Program was created to provide comprehensive information on a range of topics for patients diagnosed with early-stage (0-II) melanoma. This booklet has been reviewed for this study to include up to date information and to be complimentary to the 'Early Melanoma Guide' developed by Melanoma Institute Australia. Both booklets will be available to patients online and in paper.

The psychotherapeutic telehealth sessions are anticipated to be 30-90 minutes in duration and aim to provide empathetic, active listening in order to understand patient experiences and assist them in developing effective coping strategies. A session manual was created for use in the Melanoma Care Program, which will also be used in the present study. This intervention is based on psychodynamically-oriented psychotherapy and cognitive-behavioural therapy. Psychologist(s) delivering the intervention will be trained and supervised by The Lead Investigator (Dr. Iris Bartula) and the psychologist who developed the intervention (Prof Nadine Kasparian). The telehealth sessions will be conducted via telephone or videoconferencing at times convenient to the patient. The first session will take place as soon as possible after the patient completes screening, with each subsequent session taking place 2 weeks after. Session content interventions delivered and the adherence to strategies previously discussed will be monitored using a Telehealth Session Record From adapted from the original Melanoma Care Program.

This intervention is anticipated to be implemented for 18 months
Intervention code [1] 319056 0
Treatment: Other
Intervention code [2] 319502 0
Behaviour
Comparator / control treatment
This trial will not recruit a control group, as it is an implementation, rather than controlled trial. Control group data from the original Melanoma Care Program will be used to estimate the likely fear of cancer recurrence patterns in patients when no intervention is implemented.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325709 0
Change in patient fear of cancer recurrence severity, assessed suing the Fear of Cancer Recurrence Inventory - 9 item severity subscale.
Timepoint [1] 325709 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [1] 388850 0
Change in patient melanoma-related knowledge assessed using the purpose-designed melanoma-related knowledge survey.
Timepoint [1] 388850 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [2] 388852 0
Change in patient quality-of-life assessed using the Assessment of Quality of Life 8-Dimensions questionnaire.
Timepoint [2] 388852 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [3] 388854 0
Patient acceptability assessed using qualitative themes derived from semi-structured interviews, process data and the Acceptability of Intervention Measure survey.
Timepoint [3] 388854 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [4] 388856 0
Appropriateness of the intervention as viewed by patients, assessed through qualitative themes derived from semi-structured interviews, process data and the Intervention Appropriateness Measure survey.
Timepoint [4] 388856 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [5] 388860 0
Implementation stakeholder acceptability assessed using qualitative themes derived from expert groups and the Acceptability of Intervention Measure survey.
Timepoint [5] 388860 0
Measured pre-implementation, every three months throughout implementation and 3 months following completion of intervention.
Secondary outcome [6] 388861 0
Appropriateness of the intervention as viewed by implementation stakeholders, assessed through qualitative themes derived from expert groups and the Intervention Appropriateness Measure survey.
Timepoint [6] 388861 0
Measured pre-implementation, every three months throughout implementation and 3 months following completion of intervention.
Secondary outcome [7] 388862 0
Feasibility of the intervention as viewed by implementation stakeholders, assessed through qualitative themes derived from expert groups and the Feasibility of Intervention Measure survey.
Timepoint [7] 388862 0
Measured pre-implementation, every three months throughout implementation and 3 months following completion of intervention.
Secondary outcome [8] 388863 0
Cost of implementing the intervention assessed through process data, collected by the investigators throughout the project (e.g. number of text messages sent, number of sessions delivered, the number of information packets sent to patients, the amount of clinical time taken to communicate to patients and routinely assess FCR).
Timepoint [8] 388863 0
Data will be collected weekly and collated at the conclusion of the intervention.
Secondary outcome [9] 388864 0
Psychologist fidelity to the psychotherapeutic telehealth session manual assessed through audio-recordings of the sessions and purpose-designed fidelity checklist.
Timepoint [9] 388864 0
Data is collected throughout the study, as the telehealth sessions are conducted, and the data will be collated and analysed at the conclusion of the intervention.
Secondary outcome [10] 388865 0
Sustainability of the intervention assessed through qualitative themes derived from expert groups with implementation stakeholders, interviews with patients and measures of intervention uptake (number of patients consenting / number of patients approached) and adherence (number of attended sessions / number of total sessions offered),
Timepoint [10] 388865 0
Patient interviews: - 1 week following completion of intervention. Implementation stakeholder interviews - 3 months before implementation, 3-monlthy throughout the intervention, and 3 months following the implementation of the intervention Intervention uptake and adherence - at the conclusion of the intervention.
Secondary outcome [11] 390638 0
Change in patient's level of anxiety, as measured by Depression, Anxiety and Stress Scales (DASS-21)
Timepoint [11] 390638 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [12] 390639 0
Change in patients' level of depression as assessed by Depression, Anxiety and Stress Scales (DASS-21)
Timepoint [12] 390639 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [13] 390640 0
Change in patient's level of stress as assessed by Depression, Anxiety and Stress Scales (DASS-21)
Timepoint [13] 390640 0
Measured at baseline; 1-week, 6-months and 12-months post-intervention.
Secondary outcome [14] 406099 0
Change in patient fear of cancer-recurrence related triggers, assessed using (FCRI-42)

Timepoint [14] 406099 0
Measured at baseline, 1 week, 6 months, 12 months post intervention.
Secondary outcome [15] 406100 0
Change in patient fear of cancer-recurrence related psychological distress, assessed using (FCRI-42)
Timepoint [15] 406100 0
Measured at baseline, 1 week, 6 months, 12 months post intervention.
Secondary outcome [16] 406101 0
Change in patient fear of cancer-recurrence related coping strategies, assessed using (FCRI-42)
Timepoint [16] 406101 0
Measured at baseline, 1 week, 6 months, 12 months post intervention.
Secondary outcome [17] 406102 0
Change in patient fear of cancer-recurrence related functioning impairments, assessed using (FCRI-42)
Timepoint [17] 406102 0
Measured at baseline, 1 week, 6 months, 12 months post intervention.
Secondary outcome [18] 406103 0
Change in patient fear of cancer-recurrence related insight, assessed using (FCRI-42)
Timepoint [18] 406103 0
Measured at baseline, 1 week, 6 months, 12 months post intervention.
Secondary outcome [19] 406104 0
Change in patient fear of cancer-recurrence related reassurance, assessed using (FCRI-42)
This change has been made prior to patient recruitment commencement.
Timepoint [19] 406104 0
Measured at baseline, 1 week, 6 months, 12 months post intervention.

Eligibility
Key inclusion criteria
Diagnosis of stage 0, I or II melanoma.
Sufficient English and cognitive skills to independently read the Participant Information Sheet, Consent Form and study materials.
Able to give informed consent to participate in the study.
Sufficient hearing to participate in the psychotherapeutic telehealth sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of stage III or IV (metastatic) melanoma.
Patients with high risk of melanoma but have never received a diagnosis of the disease.
Diagnosis of severe depression, psychotic illness or other serious psychiatric condition.
Significant cognitive and / or hearing impairment that would prevent understanding of Participant Information Statement, study materials and participation in telehealth sessions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The intervention participants receive will depend on their reported severity of FCR symptoms.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Melanoma Care Program conducted sample-size calculations based on an assumption of 80% power and a two-sided a=0.05. When evaluated in a randomised-control trial, a drop in fear of cancer recurrence of -1.4 was present at 12-months post intervention. A standardised mean difference (Cohen's d) of 0.5 was also employed. It is also anticipated that 63% of patients screened for fear of cancer recurrence will reach the clinical cut-off to receive the intervention.

Based on these values a sample size of 86 is 80% powered to detect an overall between group difference of -1.4 in fear of cancer recurrence. The sample size calculation is based on a design with 4 repeated measurements (baseline, 1 week, 6-months and 12-months), having a Compound Symmetry covariance structure when the standard deviation is 4.0, the correlation between observations on the same subject is 0.5, and the type-1 error rate alpha set to 0.05. Assuming a conservative lost-to-follow-up rate of 20%, a final sample size of 108 will be recruited.

To answer the hypothesis questions of the study, statistical analyses will include descriptive statistics, measures of central tendency, linear mixed-effects regression and moderation analysis. These statistical analyses will be completed in SAS, RStudio and SPSS. Qualitative interviews and expert groups will be transcribed verbatim and thematic / content analysis will be used.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/01/2022
Actual
24/01/2022
Date of last participant enrolment
Anticipated
23/09/2022
Actual
14/09/2022
Date of last data collection
Anticipated
15/12/2023
Actual
Sample size
Target
108
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18023 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 18024 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 31993 0
2050 - Camperdown
Recruitment postcode(s) [2] 31994 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 307195 0
Charities/Societies/Foundations
Name [1] 307195 0
The Bill and Patricia Ritchie Foundation
Country [1] 307195 0
Australia
Funding source category [2] 307208 0
Charities/Societies/Foundations
Name [2] 307208 0
Melanoma Institute Australia
Country [2] 307208 0
Australia
Funding source category [3] 307209 0
University
Name [3] 307209 0
Melanoma Centre for Research Excellence
Country [3] 307209 0
Australia
Primary sponsor type
Other
Name
Melanoma Centre for Research Excellence
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 307801 0
Charities/Societies/Foundations
Name [1] 307801 0
Melanoma Institute Australia
Address [1] 307801 0
40 Rocklands Road
Wollstonecraft NSW 2067
Country [1] 307801 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307304 0
Sydney Local Health District - Royal Prince Alfred zone
Ethics committee address [1] 307304 0
Ethics committee country [1] 307304 0
Australia
Date submitted for ethics approval [1] 307304 0
04/11/2020
Approval date [1] 307304 0
04/12/2020
Ethics approval number [1] 307304 0
Protocol No X20-0495 & Approval No 2020/ETH2518

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106758 0
Dr Iris Bartula
Address 106758 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road
Wollstonecraft NSW 2065
Country 106758 0
Australia
Phone 106758 0
+61 02 9911 7398
Fax 106758 0
Email 106758 0
[email protected]
Contact person for public queries
Name 106759 0
Iris Bartula
Address 106759 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road
Wollstonecraft NSW 2065
Country 106759 0
Australia
Phone 106759 0
+61 02 9911 7398
Fax 106759 0
Email 106759 0
[email protected]
Contact person for scientific queries
Name 106760 0
Iris Bartula
Address 106760 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road
Wollstonecraft NSW 2065
Country 106760 0
Australia
Phone 106760 0
+61 02 9911 7398
Fax 106760 0
Email 106760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be de-identified using unique patient ID's before analysis. This de-identified data will be made available for sharing, and will include patient baseline and follow-up questionnaires. De-identified transcripts of patient interviews will also be made available. No other data (audio-recordings, signed consent forms etc.) that could be used to identify a patient will be available.
When will data be available (start and end dates)?
De-identified data will be available post-publication of the study results. The de-identified data will be available indefinitely.
Available to whom?
De-identified data will be available to any researchers who submit a methodologically-sound, HREC-approved research approval to use the data to Dr. Bartula, who will consult with the investigator team and release data if deemed appropriate
Available for what types of analyses?
De-identified data will be available to achieve objectives as outlined in the proposal that has been approved by Dr Bartula and investigators.
How or where can data be obtained?
Please contact Dr. Bartula:
Melanoma Institute Australia
Poche Centre
40 Rocklands Road
Wollstonecraft NSW 2065
02 9911 7398
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9734Study protocol  [email protected]
9735OtherData dictionary [email protected] Data dictionary
9736Ethical approval  [email protected]



Results publications and other study-related documents

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