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Mental health
Protocol
Protocol for the implementation of a stepped-care model to address fear of cancer recurrence in patients previously diagnosed with early-stage (0–II) melanoma
  1. Jake R Thompson1,
  2. Andrea L Smith2,3,
  3. Serigne N Lo1,
  4. Nadine A Kasparian4,5,
  5. Robyn PM Saw1,6,
  6. Mbathio Dieng7,
  7. Linda Seaman8,
  8. Linda K Martin1,9,
  9. Pascale Guitera1,10,
  10. Donna Milne11,
  11. Helen Schmid3,12,
  12. Anne E Cust1,3,
  13. Iris Bartula1
  1. 1Melanoma Institute Australia, University of Sydney, North Sydney, New South Wales, Australia
  2. 2Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia
  3. 3The Daffodil Centre, The University of Sydney, a joint venture with Cancer Council NSW, Sydney, New South Wales, Australia
  4. 4Cincinnati Children's Center for Heart Disease and Mental Health, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
  5. 5Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
  6. 6Department of Melanoma and Surgical Oncology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
  7. 7NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia
  8. 8Consumer Representative, Sydney, New South Wales, Australia
  9. 9Faculty of Medicine and Health, University of New South Wales, Kensington, New South Wales, Australia
  10. 10Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
  11. 11Melanoma and Skin Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  12. 12Westmead Institute for Medical Research, The University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Jake R Thompson; jake.thompson{at}melanoma.org.au

Abstract

Introduction Fear of cancer recurrence (FCR) is commonly reported by patients diagnosed with early-stage (0–II) melanoma and can have a significant impact on daily functioning. This study will pilot the implementation of the Melanoma Care Program, an evidence-based, psychological intervention to reduce FCR, into routine practice, using a stepped-care model.

Methods and analysis Intervention effectiveness and level of implementation will be investigated using a hybrid type I design. Between 4 weeks before and 1 week after their next dermatological appointment, patients with melanoma will be invited to complete the Fear of Cancer Recurrence Inventory Short-Form, measuring self-reported FCR severity. Using a stepped-care model, clinical cut-off points will guide the level of support offered to patients. This includes: (1) usual care, (2) Melanoma: Questions and Answers psychoeducational booklet, and (3) three or five psychotherapeutic telehealth sessions. This longitudinal, mixed-methods pilot implementation study aims to recruit 108 patients previously diagnosed with stage 0–II melanoma. The primary effectiveness outcome is change in FCR severity over time. Secondary effectiveness outcomes include change in anxiety, depression, stress, health-related quality of life and melanoma-related knowledge over time. All outcomes are measured at baseline, within 1 week of the final telehealth session, and 6 and 12 months post-intervention. Implementation stakeholders at each study site and interested patients will provide feedback on intervention acceptability and appropriateness. Implementation stakeholders will also provide feedback on intervention cost, feasibility, fidelity and sustainability. These outcomes will be measured throughout implementation, using questionnaires and semistructured interviews/expert group discussions. Descriptive statistics, linear mixed-effects regression and thematic analysis will be used to analyse study data.

Ethics and dissemination Ethics approval was granted by the Sydney Local Health District–Royal Prince Alfred Zone (2020/ETH02518), protocol number: X20-0495. Results will be disseminated through peer-reviewed journals, conference presentations, social media and result summaries distributed to interested participants.

Trial registration details (ACTRN12621000145808).

  • mental health
  • anxiety disorders
  • qualitative research
  • dermatological tumours
  • adult oncology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2021-054337

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    Strengths and limitations of this study

    • This study aims to evaluate the pilot implementation of the evidence-based Melanoma Care Program into the routine clinical care of patients previously diagnosed with early-stage (0–II) melanoma.

    • It is the first study to implement a stepped-care model to routinely screen for fear of cancer recurrence (FCR) in patients previously diagnosed with early-stage melanoma and tailor the intensity of intervention to reported FCR severity.

    • Consumer representatives, practice managers, directors and clinicians have been involved throughout the study design process.

    • The hybrid type I design allows for the simultaneous evaluation of clinical and implementation outcomes.

    • The primary limitation of this pilot implementation study is the absence of a recruited control group; however, control group data from the Melanoma Care Program randomised controlled trial will be used as an ad hoc comparison group.

    Introduction

    Background and rationale

    The global incidence of melanoma is increasing,1 with an estimated 324 635 individuals receiving a diagnosis of melanoma in 2020.2 Australia and New Zealand have the highest melanoma incidence rate in the world.3 In 2016, the Australian age-standardised incidence and mortality rates of melanoma were 53.5 cases per 100 000 and 4.5 deaths per 100 000, respectively.4 The average 5-year survival rates of patients with stage I and II melanoma are 99.2% and 73.6%, respectively,4 increasing the importance of their psychosocial adjustment and quality of life. Fear of cancer recurrence (FCR), defined as the fear, worry or concern that cancer may return or progress,5 is the most frequently reported challenge of this population.6 FCR is associated with: lower emotional, physical, role and social functioning, and health-related quality of life (HRQOL); poorer healthcare satisfaction; and increased reassurance-seeking behaviour, fatigue, pain, distress, anxiety and depressive symptoms.7

    A meta-analysis of 23 psychological interventions targeting FCR found them to be effective; however, only one intervention, the Melanoma Care Program (MCP), focused on Australian patients with melanoma.8 The MCP is a brief, evidence-based psychological intervention developed to address FCR in patients with a previous diagnosis of early-stage melanoma at risk of developing new primary disease.9 10 The intervention consists of two components: (1) a Melanoma: Questions and Answers (MQA) psychoeducational booklet,10 11 and (2) three psychotherapeutic telehealth sessions scheduled around patients’ dermatological visits.10 This is the first intervention specifically developed for patients with a previous diagnosis of early-stage melanoma. When investigated in a randomised controlled trial, intervention participants reported significantly lower FCR severity compared with a control group immediately post-intervention and at 6-month follow-up,9 with effects sustained at 12-month follow-up.12 The intervention was also well accepted by patients9 and cost-effective.13 While the efficacy of this intervention was established, the randomised controlled trial did not assess patients’ FCR severity prior to trial enrolment to tailor intervention intensity to patient need. The present protocol outlines a pilot implementation study to translate this evidence-based intervention into real-world clinical settings, using a stepped-care approach. Patients with a previous diagnosis of early-stage melanoma attending routine dermatological appointments will be screened for FCR, allowing the intensity of support to match the severity of the patients’ FCR.

    Study aims and hypotheses

    The primary aim of this study is to examine the effectiveness of a stepped-care model offering the MCP (henceforth referred to as the ‘Melanoma Care Program–stepped-care intervention’ or MCP-SCI) in reducing FCR severity in patients with a previous diagnosis of early-stage melanoma who are identified as having elevated FCR in routine clinical practice.

    Secondary aims include:

    • Evaluation of the effects of the MCP-SCI on patient-reported depression, anxiety, stress, melanoma-related knowledge, HRQOL and further aspects of FCR: triggers, psychological distress, coping strategies, functional impairments, insight and reassurance.

    • Evaluation of the sustainability of routine implementation of the MCP-SCI in real-world clinical settings by documenting barriers (eg, low screening uptake, time and cost of screening) and facilitators (eg, participant engagement and screening adherence) and assessing the usefulness of strategies to address barriers.

    It is hypothesised that:

    1. Patients who report elevated FCR and receive the MCP-SCI will report immediately, and at 6-month and 12-month follow-up:

      • A significant reduction in FCR severity.

      • A decrease in FCR-related triggers, psychological distress, functional impairments, reassurance-seeking behaviour and patient-reported levels of depression, anxiety and stress.

      • An increase in FCR-related coping strategies and insight, melanoma-related knowledge and HRQOL compared with baseline scores.

    2. The implementation of the MCP-SCI will be considered:

      • Acceptable and appropriate by patients who receive the intervention.

      • Acceptable, appropriate, feasible and sustainable by implementation stakeholders.

    3. The MCP-SCI will be delivered with high fidelity and adherence to the therapist manual.

    Methods

    Study design

    Translational research investigates the degree to which an evidence-based practice retains its effectiveness when implemented into ‘real-world’ settings.14 The hybrid effectiveness–implementation design, which focuses on assessing both the effectiveness and implementation of an evidence-based practice, is commonly used in translational research.15 Three variations of this design exist, based on the relative focus that is placed a priori on effectiveness and implementation outcomes. Type I designs primarily evaluate the health and well-being impact of an evidence-based practice in real-world settings, while also gathering contextual information on the implementation process to guide future implementation efforts.15 Thus, a type I design was selected for this study to investigate the effects of the MCP-SCI in routine practice, while evidence concerning its long-term sustainability is gathered to guide more extensive implementation efforts in the future.

    Setting

    Implementation will take place at two of the three dermatology clinics specialising in the diagnosis and treatment of melanoma that participated in the MCP randomised controlled trial.9 10 The first study site, Melanoma Dermatology, is located within the Poche Centre at Melanoma Institute Australia (MIA), the world’s largest melanoma research and treatment facility. The second study site, Sydney Melanoma Diagnostic Centre, is also associated with MIA and is located at Royal Prince Alfred Hospital. Both study sites are located in metropolitan Sydney, Australia; are mixed public and private practices that have extensive experience in conducting melanoma-related research and implementation studies; have strong organisational emphasis on multidisciplinary collaboration, research and clinician training; consist of roughly a dozen clinicians and administration staff; and primarily see patients with melanoma at high risk of recurrence.

    Participant selection

    Two groups of participants will be included: (1) patients with a current or previous diagnosis of early-stage melanoma who have an upcoming follow-up appointment at either of the study sites, and (2) implementation stakeholders, including investigators of the MCP randomised controlled trial, and individuals who are involved in the implementation of the MCP-SCI at one of the study sites (ie, dermatologists, nurses, practice managers, administration staff). Table 1 outlines the study inclusion and exclusion criteria.

    View this table:
    Table 1

    Participant inclusion and exclusion criteria

    Participant recruitment

    Patients

    Four weeks prior to their routine scheduled appointment, patients will be invited to participate via an automated text message. This time frame allows for individuals with high FCR to be identified and offered the intervention prior to the week of their appointment, when anxiety is likely to be greatest.16 The text message invitation contains a brief introduction to the study and a link to MIA’s Research Electronic Data Capture webpage, which includes a landing page describing the study, participant information statement, consent form, Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)17 and relevant questionnaires. During an eligible patient’s appointment, their clinician will check that the text message was received and answer any questions about the study. If the patient did not receive the text message, the clinician can discuss the study with the patient and collect their contact details if interested. A research assistant will then call the patient within 48 hours of the appointment to discuss the study.

    Implementation stakeholders

    The chief investigator at each study site will approach potential implementation stakeholders via email or in person. Additionally, members of the investigative team of the MCP randomised controlled trial will be invited to participate as implementation stakeholders, as these individuals have first-hand experience with the intervention and may foresee possible implementation issues. A reminder invitation will be sent 2 weeks following initial contact if no response is received.

    The recruitment of implementation stakeholders began in June 2021. Patient recruitment began in January 2022. Study completion is expected by October 2023.

    Intervention description

    MQA booklet and psychotherapeutic telehealth sessions

    The MCP intervention consists of the MQA booklet and psychotherapeutic telehealth sessions. These two components have not been substantially altered for this pilot implementation study. Table 2 provides a brief description of the MCP intervention provided to patients in the randomised controlled trial and outlines the justification for any modifications made for the present implementation study.

    View this table:
    Table 2

    Description of the MCP intervention

    The content of the psychotherapeutic telehealth sessions is provided in table 3.

    View this table:
    Table 3

    Outline of psychotherapeutic telehealth sessions

    Stepped-care model of intervention delivery

    The addition of a stepped-care model of care will allow the intervention to be tailored to each patient’s severity of FCR, potentially maximising overall benefit and service provision efficiency while conserving resources.18

    Patients will be invited to complete FCR screening using the FCRI-SF. The FCRI-SF is measured using a nine-item, 5-point Likert scale with scores ranging from 0 to 36, with higher scores indicating greater FCR severity.17 Multiple cut-off scores have been suggested in the literature. For the purpose of this pilot implementation study, a cut-off score of ≥1319 will be used to identify patients with clinically indicative levels of FCR to receive the MCP-SCI, with a second cut-off core of ≥2220 used to identify patients with more severe levels of FCR at baseline (table 4). These cut-off scores were chosen as a preference was placed on sensitivity over specificity to ensure patients experiencing FCR are captured, and the MCP randomised controlled trial subgroup analysis finding participants scoring ≥13 at baseline experienced a significant decrease in FCR severity at 6-month follow-up,9 whereas participants scoring ≥22 at baseline experienced no significant decrease,12 which investigators attributed to potential dose-response effect. Hence, it was decided to offer two additional sessions to those who score ≥22 at baseline to investigate its effects.

    View this table:
    Table 4

    Stepped-care model

    Patients triaged to step 1 (no/low FCR) will receive usual care, consisting of clinical follow-up and MIA’s Your Guide to Early Melanoma (Third Edition) booklet. Patients triaged to step 2 (moderate FCR) and step 3 (severe FCR) will continue to receive usual care as well as being offered the MCP intervention, with the difference between these steps being the number of telehealth sessions offered to the patient (table 3). The psychologist(s) will contact patients to schedule their first session, ideally conducting the first session before the patients’ upcoming appointment. Subsequent telehealth sessions will be conducted on a flexible 2-week basis.

    Data collection

    Patients

    In addition to completing the FCRI-SF, patients triaged to step 1 (no/low FCR) will complete a demographic questionnaire. Patients triaged to step 2 (moderate FCR) and step 3 (severe FCR) will complete the demographic questionnaire plus a baseline questionnaire collecting data relating to outcome measures of interest. Patients triaged to step 2 or 3 will also complete questionnaires within 1 week of completing their final telehealth session and at 6-month and 12-month follow-up. All patients who receive the intervention will be invited to participate in a semistructured interview during their first follow-up questionnaire to explore their experiences of the MCP-SCI. Recruitment will continue until thematic saturation is reached, and purposeful sampling used to ensure a range of experiences are captured. The Theoretical Framework of Acceptability21 will be used to guide these semistructured interviews. This framework consists of seven constructs relevant to intervention acceptability: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.

    Patients will choose whether to complete questionnaires electronically or in paper format. A reminder email/letter will be sent to patients who do not provide a response after 2 weeks, with a telephone reminder after 4 weeks.

    Implementation stakeholders

    Three expert groups will be formed to explore the perceptions of implementation stakeholders to gather information about barriers and facilitators to implementation. The first group, consisting of investigators of the MCP randomised controlled trial, will meet pre-implementation to discuss barriers and facilitators experienced during the trial and any foreseeable barriers during implementation in routine clinical practice. The second and third groups, consisting of implementation stakeholders at the two study sites, will meet 3 months prior to, and quarterly throughout implementation, to discuss key barriers and strategies to address them, meeting a final time 3 months post-implementation to discuss long-term sustainability of the intervention. These expert group discussions will be guided by the Consolidated Framework for Implementation Research and will be audio-recorded and transcribed for thematic analysis.22

    Formative evaluation will be used to assess the effectiveness of any strategies put in place to address barriers that are identified during the implementation process,14 with information collected shared with investigators and stakeholders allowing the implementation process to adapt to any barriers. Summaries of each expert group and agreed upon modifications will be provided to the study sites within a week of each expert group discussion, allowing implementation stakeholders to enact any changes. This will allow investigators to evaluate the effects of strategies used to address barriers to implementation.

    At the conclusion of each expert group, implementation stakeholders will be offered questionnaires to quantitatively explore the acceptability, appropriateness and feasibility of the intervention.

    Outcomes

    Consistent with the hybrid type I design, the primary outcome is the effectiveness of the MCP-SCI in reducing patient FCR severity. A summary of the outcome assessment methods is presented in table 5.

    View this table:
    Table 5

    Outcome variables, measures, psychometric properties and timeline of data collection

    Primary outcome

    The primary outcome of this study is change in patient self-reported levels of FCR severity over time, measured using the FCRI-SF, the severity subscale of the Fear of Cancer Recurrence Inventory 42-item Form (FCRI).17

    Secondary effectiveness outcomes

    Changes over time in all other subscales of the FCRI (triggers, psychological distress, coping strategies, functional impairments, insight and reassurance) will be measured and reported as secondary outcomes. The FCRI consists of 42 items that patients answer using a 5-point Likert scale. Higher scores indicate higher levels of FCR. The FCRI has demonstrated psychometric properties (table 5) and has been validated in Australians with a history of early-stage melanoma.23

    Change over time in melanoma-related knowledge will be measured using a purpose-designed questionnaire, adapted from the MCP randomised controlled trial. This questionnaire was updated in tandem with the MQA booklet, to ensure the questions and answers continue to reflect the information provided in the booklet. Higher scores on this scale correspond to higher levels of melanoma-related knowledge, which is measured using multiple choice, true/false and yes/no style questions.

    Changes over time in depression, anxiety and stress will be measured using the Depression, Anxiety and Stress Scales 21-item Short Form (DASS-21).24 The DASS-21 is measured using a 4-point Likert scale, with higher scores indicating more severe symptoms of depression, anxiety or stress. The DASS-21 has demonstrated psychometric properties (see table 5) and has clinical cut-off24 and clinically meaningful25 scores defined.

    Change over time in HRQOL will be measured using the Assessment of Quality of Life–8 Dimensions (AQOL-8D).26 The AQOL-8D contains 35 questions to which patients respond using Likert scales ranging from 4 to 6 points. The AQOL-8D has demonstrated psychometric properties (see table 5). The AQOL-8D scores comprise two super dimensions (physical and psychosocial) consisting of eight smaller dimensions (independent living, pain, senses, mental health, happiness, coping, relationships and self-worth). Higher scores indicate worse quality of life.

    Secondary implementation outcomes

    The acceptability and appropriateness of the MCP-SCI from a patient’s perspective will be quantitatively measured using the Acceptability of Intervention Measure and Intervention Appropriateness Measure, respectively.27 Each of these measures consists of four positively worded items, measured on a 5-point Likert scale. As no cut-off scores exist, scores of 4/5 (agree) and 5/5 (strongly agree) will be used to indicate that the MCP-SCI is considered acceptable and appropriate by patients. Furthermore, semistructured interviews with patients will be used to further explore the perceptions of patients. Acceptability will also be measured using intervention adherence rates.

    Implementation stakeholders will provide further feedback regarding the acceptability and appropriateness of the MCP-SCI. This will be quantitatively measured using the Acceptability of Intervention and Intervention Appropriateness Measures. Furthermore, implementation stakeholders will also provide feedback regarding the feasibility or the MCP-SCI, quantitatively measured using the Feasibility of Intervention Measure.27 Lastly, expert group discussions with implementation stakeholders will be used to further explore their perceptions of the MCP-SCI.

    The cost of implementation will be reported using process data, which will include costs associated with the MQA booklet (ie, time to update, graphic design and printing), training, salary of a psychologist, text messaging, online screening and survey development, stationery, transcribing interviews and any other incidental expenses. These expenditures will be categorised into costs associated with research, initiating implementation and ongoing implementation.

    Fidelity of the telehealth sessions to the psychologist manual will be assessed using a purpose-designed fidelity checklist adapted from the MCP.9 This checklist includes items specifically designed to review the content of each session, including the items from the Comparative Psychotherapy Process Scale,28 Revised Cognitive Therapy Scale,29 and Interpretive and Supportive Technique Scale.30 To ensure the psychologist manual is adequately followed, 10% of conducted telehealth sessions will be randomly reviewed and assessed.

    Finally, sustainability will be assessed through the degree to which the intervention has been incorporated into routine clinical care at the study sites. The sustainability of the MCP-SCI will be discussed with implementation stakeholders through expert group discussions.

    Sample size

    At 12 months post-intervention, the MCP randomised controlled trial demonstrated a reduction in FCR severity of −1.41.12 Based on this value, a sample size of 86 will provide 90% power to detect an overall before/after difference of −1.41 in FCR severity between baseline and 12 months post-intervention. This sample size calculation is based on a paired mean difference design with an SD of 4.0 and type 1 (alpha) error rate set to 0.05.31 Assuming a conservative lost-to-follow-up rate of 20%, a final sample of 108 patients across both study sites will be recruited and offered the MCP-SCI. As it is anticipated that approximately 63% of patients who complete screening will be offered the intervention,32 an estimated 172 patients will complete screening, with recruitment continuing until the required sample of 108 patients is achieved.

    Data analysis plan

    All patients who receive the intervention will be analysed as one group with the number of psychotherapeutic telehealth sessions received and baseline FCR scores treated as covariates. Linear mixed-effects regression will be used to analyse the effect of the intervention on patient psychosocial outcomes, as it can robustly deal with missing data and perform hypothesis testing on longitudinal data.33 Furthermore, the FCR trajectory of both the intervention group and the control group recruited in the MCP randomised controlled trial12 will be graphically displayed in the same figure using mean scores at baseline, 1-week, 6-month and 12-month follow-up with 95% CIs for ad hoc comparison. No formal statistical inference will be performed to compare the two groups. Moderation analysis will also be used to examine the effects of covariates on the relationship between all outcomes and independent variables through linear regression.34 Thematic analysis will be used to analyse the semistructured interviews and expert group discussions conducted throughout the study for common themes regarding facilitators and barriers.35 Quantitative analysis will be completed in IBM SPSS Statistics V.26 (IBM Corp) and RStudio (RStudio Team 2019, V.1.2.5033); qualitative analysis will be conducted using NVivo V.12 Plus (QSR International).

    Ethics

    Ethical approval was received from the Sydney Local Health District–Royal Prince Alfred Zone (2020/ETH02518). Any future amendments to the protocol will be approved by the Steering Committee, Human Research Ethics Council, site approval boards and the corresponding clinical trial registry updated. Participants enrolled in the study will be informed by JRT. Based on the MCP randomised controlled trial, it is unlikely that patient participants will experience adverse effects from the stepped-care intervention, as only three participants (4%) found discussing their melanoma experiences with a psychologist confronting.36 Any discomfort will be addressed during the telehealth sessions. Furthermore, any participants identified to have a significant comorbid mental health condition will be referred for community mental health support to better address their needs.

    Dissemination plans

    Results will be shared with academics, researchers, clinicians, interested patients and other key stakeholders. Results will be disseminated to peer-reviewed journals, scientific meetings and conferences and reported according to the Standards for Reporting Implementation Studies statement.37 The associated checklist38 will be used to ensure all relevant aspects of the intervention study are included in analysis and reporting. Authorship will be determined by the criteria outlined in the International Committee for Medical Journal Editors.39

    Data availability

    To facilitate research transparency, reproducibility and accuracy, de-identified data will be available for sharing. Interested researchers can contact the corresponding investigator following the publication of the 12-month follow-up data. Data access will be granted to the projects that are considered by the investigative team to be methodologically sound and Human Research Ethics Committee approved. The investigative team will create a project-specific workspace within MIA’s secure server, which will house the de-identified data and technical appendices.

    Patient and public involvement

    The design of this study, its aim and outcome measures are a result of the positive outcomes and satisfaction reported by the participants of the MCP randomised controlled trial,36 as well as the clinical experiences of the investigative team regarding patients experiencing anxiety and FCR. The investigative team also includes a consumer representative who has provided guidance on the design of the study and its materials, approved of the intervention’s possible burden on patients and will continue to provide guidance throughout implementation as barriers are identified. No consumers are directly involved in the recruitment process. A lay summary of results will be provided to any interested patients and posted on the MIA website.

    Discussion

    Strengths

    This pilot implementation study represents the next logical step in the translation of an evidence-based psychotherapeutic intervention to reduce FCR in patients with a previous diagnosis of early-stage melanoma into routine clinical practice. The study design will allow for concurrent assessment of effectiveness and implementation variables using a mixed-methods design which includes quantitative data obtained through use of validated and accepted outcome measures, with contextual information obtained from interviews and expert groups. Screening will be used to identify patients experiencing elevated FCR and ensure patients are offered the appropriate level of support to address their needs. This screening will take place between 4 weeks before and 1 week after a scheduled appointment in an attempt to capture the background levels of FCR experienced by the patient, as fear often increases in the week before an appointment.16 Consumer representatives, practice managers, directors and clinicians were included in the study design process, ensuring the intervention has the utmost relevance to patient needs and will suit the organisational structure of the study sites.

    Limitations

    Similar to the MCP, the study design precludes determination of the relative contribution of the MQA booklet and psychotherapeutic telehealth sessions in achieving outcomes. Further studies may be designed to systematically investigate this. Furthermore, a control group will not be recruited, as withholding evidence-based intervention from patients who may screen high on FCR in the control group was not considered ethical. Available control group data from the MCP randomised controlled trial will act as a comparison group to estimate 12-month FCR trajectories without an intervention. Furthermore, there is a risk of recruitment bias as patients with severe FCR may avoid participating in this study. The extent of this recruitment bias will be estimated by comparing recruitment rates with other interventional studies in the melanoma literature.

    Significance

    Information on the implementation of evidence-based psychosocial interventions into routine melanoma practice is sparse. Only one study was identified that evaluated the implementation of an FCR intervention into routine practice. The Fear-Less40 Study evaluated a stepped-care model on patients with metastatic (stage IV) melanoma, using the ConquerFear41 intervention, which, in a clinical trial, was found to be effective in reducing FCR in patients with breast and colorectal cancer and melanoma.42 Fear-Less was found to be both acceptable and feasible. The small sample size precluded determination whether the observed reduction in FCR was statistically significant or clinically meaningful. This study will be the first to provide a stepped-care intervention for patients with a previous diagnosis of early-stage melanoma reporting elevated FCR in routine clinical practice, using an intervention that has been specifically created for patients with melanoma; addresses both the international43 and Australian44 research agenda for FCR, specifically as it uses a stepped-care model, facilitates routine implementation of an evidence-based intervention, and provides access to telehealth interventions to patients outside of clinical trials; is sufficiently powered to assess the impact of the intervention on FCR severity; and will be the first to investigate the acceptability, appropriateness, feasibility, fidelity and sustainability of a psychosocial intervention implemented into routine practice to address FCR in patients previously diagnosed with early-stage melanoma, from both the consumer and service-provider perspective. The implementation information obtained may be used in future implementation efforts as research moves from the strict confines of clinical trials into real-world settings.

    Ethics statements

    Patient consent for publication

    Acknowledgments

    The authors wish to thank Ms Ivy Tan for software assistance, Dr Niamh O’Sullivan for assisting with the Melanoma: Questions and Answers booklet review, Melanoma Institute Australia and Sydney Melanoma Diagnostic Centre.

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    Footnotes

    • Contributors NAK, RS, MD, JRT, IB and AEC were responsible for the concept of this study. A Steering Committee comprising of JRT, IB, ALS, LS, LM, PG, NAK, RS, MD, HS, AEC, SL and DM contributed to study design, intervention and material development. JRT, IB, LM, PG and ALS will be responsible for overseeing the implementation process. JRT, IB and ALS will be responsible for data collection and management. JRT, IB, ALS, MD and SL will conduct the statistical analysis of results. All authors will be involved in results interpretation. All authors contributed and approved this manuscript.

    • Funding This implementation trial was supported by the Melanoma Centre of Research Excellence (The University of Sydney, New South Wales, Australia), which is funded by the National Health and Medical Research Council of Australia (grant number: 1135285). This work was also supported by Melanoma Institute Australia and the Bill and Patricia Ritchie Foundation. NAK is the recipient of a National Heart Foundation of Australia Future Leader Fellowship (101229) and support from the Heart Institute Research Core at Cincinnati Children’s Hospital. AEC has received a National Health and Medical Research Council Career Development Fellowship (1147843).

    • Disclaimer The funding sources had no role in the design of this study and will not have any role during its implementation, analysis or decision to publish results.

    • Competing interests RS has received honoraria for advisory board participation from MSD, Novartis and QBiotics, and speaking honoraria from BMS. DM has received honoraria for advisory board participation from MSD, BMS and Novartis, and speaking honoraria from BMS and MSD.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.