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Implementing a Stepped Care Model to Address Fear of Cancer Recurrence in Early Stage (0-II) Melanoma Patients - A Pilot Study

Implementing a Stepped Care Model to Address Fear of Cancer Recurrence in Early Stage (0-II) Melanoma Patients - A Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000145808
Acronym
PSI (Psychological Support Implementation) Study
Enrollment
115
Registered
2021-02-12
Start date
2022-01-24
Completion date
2022-09-14
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial is evaluating the implementation of the Melanoma Care Program intervention addressing fear of cancer recurrence in routine clinical settings at both Melanoma Institute Australia and Royal Prince Alfred Hospital. Who is it for? You may be eligible for this trial if you are aged over 18 years and have a diagnosis of stage 0, I or II melanoma. Study details Based on initial screening of fear of cancer recurrence, participants will be allocated to an intervention arm based on their needs. They will receive a mix of standard care (usual patient education and support), access to the Melanoma: Questions and Answers booklet, and a variable number of psychotherapeutic telehealth sessions. They will then be asked to complete a number of questionnaires assessing their knowledge of melanoma, mental health-related outcomes and response to the program. Information from this study will be used to potentially implement the Melanoma Care Program into routine clinical practice in future.

Interventions

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-inte

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

Sponsors

Melanoma Centre for Research Excellence
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026