None listed
Conditions
Brief summary
The purpose of this study is to determine if a nurse-led, distance-delivered intervention called ‘Re-engage’ can be used in childhood brain cancer survivors to increase health-related self-efficacy, improve their long-term physical and mental health, and quality of life. Who is it for? Survivors are eligible if they were diagnosed with a brain cancer (any nervous system tumour) prior to the age of 18 years, and were diagnosed more than 5 years prior to participation in the study. At the time of study participation, survivors may be of any age, however if aged 14 years or younger, parents participate on their behalf. Survivors must have completed active treatment, be in remission and have not received any specialist survivorship care in the past 18 months. Study details: This project will offer young ‘disengaged’ survivors of childhood brain cancer who currently access no cancer follow-up care a novel, free, and low burden intervention to identify their risk factors and improve their physical and mental health. All participants in this study will receive two live, online consultations with a clinical nurse consultant, and a medical case review with a multi-disciplinary team. The purpose of these consultations and reviews is to triage and provide referral pathways to appropriate follow-up services. The primary outcome for the trial will be survivors’ self-reported health-related self-efficacy and quality of life. Participants will also need to complete four questionnaires at 1, 6, 12, and 24 months post-intervention. Despite recommendations for regular medical follow-up, many young survivors do not access any regular cancer-specific follow-up care to address health concerns. Without early intervention, late effects can shorten survivors’ lives and can severely impact quality of life. Critically, many of the health and psychosocial problems childhood brain cancer survivors experience can be prevented or managed better with effective survivorship care. Summation: It is hoped that this research will determine whether a novel nurse-led intervention is acceptable to, and enables re-engagement of childhood brain cancer survivors which may lead to improved health outcomes in the longer term.
Interventions
This project is a Type II Hybrid effectiveness-implementation study aimed at evaluating a nurse-led, distance delivered intervention for survivors of childhood brain cancer who have become disengaged with their cancer follow-up.
The Engage program will offer ‘disengaged’ survivors of childhood brain cancer (i.e. survivors who have not received specialist survivorship care in the past 2 years), a remotely delivered multidisciplinary case review to identify their risk factors and improve their p
This project is a Type II Hybrid effectiveness-implementation study aimed at evaluating a nurse-led, distance delivered intervention for survivors of childhood brain cancer who have become disengaged with their cancer follow-up. The Engage program will offer ‘disengaged’ survivors of childhood brain cancer (i.e. survivors who have not received specialist survivorship care in the past 2 years), a remotely delivered multidisciplinary case review to identify their risk factors and improve their physical and emotional health. Engage is a synchronous, i.e. ‘live’, intervention with the option of being delivered online using videoconferencing or alternatively by telephone if requested. Participants will be survivors who were diagnosed with brain cancer prior to the age of 18. For participants aged 14 or younger, parents of survivors will participate instead of the survivor. The most appropriate party (survivor or parent) to participate is at the decision of the family in discussion with the Clinical Nurse Consultant and based on the maturity of the young adult and family preferences. The intervention involves four components: 1. An online, ‘live’, consultation with a clinical nurse consultant (CNC) specializing in childhood cancer survivorship, to collect the patients’ medical history and assess their personal risk factors. The anticipated duration of the initial ‘live’ consultation with a clinical nurse consultant is 40 to 60 minutes. The ‘e-Health management tool’ has been replaced by an online survey about the survivor’s health and a nurse consultation conducted via zoom. All digital components of the study or e-health use is on an as-needs basis (i.e. dependent on how long it takes to complete the questionnaire or how long the survivor would like to talk to the nurse). 2. Medical case review by a multi-disciplinary team (MDT) specializing in cancer survivorship to determine tailored recommendations for each survivor. Recommendations are to address the survivor’s physical and mental health, as well as early intervention/prevention measures such as surveillance schedules and the discussion of positive health behaviours. The MDT will include at a minimum, a pediatric oncologist, general practitioner, survivorship nurse, social worker, or psychologist. Additional panel members may include an adult oncologist, endocrinologist, neurologist, radiation oncologist, and allied health specialists (e.g. occupational therapists, exercise physiology, or physiotherapy). 3. A written treatment summary and MDT summary report will be sent to the survivor and their GP. The detailed report will outline in lay language the survivor’s risk of developing specific late effects and provide tailored recommendations that reflect the survivor’s health care needs and appropriate surveillance schedules. 4. A second online consultation with the CNC will be provided to ensure that the survivor receives education about their cancer treatment, risks, and the MDT’s recommendations for the care of late effects. It will ensure survivors are engaged and empowered to manage their own health and there are no known barriers to prevent their adherence to the MDTs recommendations. The nurse will also focus on the importance of having a regular primary care physician and maintaining positive health behaviors (such as exercise, diet, sunscreen use, and abstaining from smoking, and excessive alcohol consumption/drug use). The consultation is expected to have a duration of approximately 40 to 60 minutes, but this is dependent on the nature and number of recommendations provided to the participant. 5.A brief booster session will be provided by the CNC 3-months after the MDT review. It will discuss the survivor’s adherence to recommendations and troubleshoot any barriers to care. Participants will also be invited to complete a questionnaire 1 week prior to the intervention (T1), followed by follow-up questionnaires at 1 month, 6 months, 12 months and 24 months (T2, T3, T4, T5). Adherence will be monitored in a number of ways. In terms of adherence to the intervention’s delivery, all nurse consults will be audio recorded and transcribed verbatim by a professional transcription service. These transcripts will be coded and independently reviewed to assess intervention fidelity. The nurse will also be required to complete a survey during/after each consultation to report whether or not they adhered to each component of the planned consultation. Consultation length (hours and minutes) will be recorded. Participants’ adherence to the recommendations made by the MDT will be assessed via the research questionnaires (administered at one-, six-, twelve- and twenty-four months post-intervention). The questionnaires will ask the participant whether they have adhered to each individual recommendation, as well as health behaviour guidelines. As well as analyzing the effectiveness of this intervention, we seek to better understand how a clinical intervention such as this is implemented within a hospital setting. As such, our implementation science team will be conducting qualitative interviews with various stakeholders, including hospital management, the clinical team involved in intervention delivery, and participants. This will take a staged approach, initially reflecting on lessons learned from the pilot study, followed by interviews related to the processes necessary to implement the program, and finally, after the completion of the trial, reflections on how to improve future implementation.
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Study inclusion criteria are defined as any individual who: i) Was diagnosed with a brain cancer* prior to age 18 years (the survivor may currently be any age**); ii) Was diagnosed with brain cancer more than 5 years prior to study participation (i.e. they have entered long term survivorship); iii) Was treated for brain cancer at one of the participating hospitals (Sydney Children’s Hospital, The Children’s Hospital at Westmead, and Perth Children’s Hospital); iv) Has completed active treatment, is alive and in remission at the time of study participation; and v) Has not received specialist survivorship care in the past 18 months***. vi) Provides a referral letter from their GP, addressed to the lead specialist of the MDT (as would be the case in all instances where a specialist is requested to provide clinical care). Note: * Brain cancer is defined as any central nervous system tumour, including but not limited to intracranial tumours. Both low- and high-grade brain cancers will be eligible for inclusion. Survivors who have experienced cancer recurrence after their first brain cancer diagnosis will remain eligible, as long as they have completed treatment for the recurrence with curative intent before their first consultation with the nurse. ** For survivors who are aged 14 years or younger, we will request the parent participate on their behalf. For survivors aged between 14-18 years of age, they or their parent(s), may participate in the study, based on the maturity of the young adult and family preferences. For all minors (<18 years of age), parents will be approached via the Parent Invitation Letter, and encouraged to provide the accompanying Survivor Invitation Letter and Survivor Information Sheet to their child in order to jointly make a decision around participation. *** “Has not received specialist survivorship care” will be defined as a survivor who has not received care from an oncologist with survivorship expertise. The survivor will remain eligible for inclusion if they have received cancer-related care from their GP. The survivor will remain eligible for inclusion if they have received cancer-related care from their GP. . Survivors whose specialist survivorship care physician believes they would benefit from further engagement will also be eligible. Survivors who express that they have not received adequate care to address the full spectrum of their medical and psychosocial needs will also be eligible.
Exclusion criteria
Study exclusion criteria are defined as any individual who: i) Was first diagnosed with brain cancer when they were over 18 years of age; ii) Was diagnosed with brain cancer less than 5 years ago; iii) Is currently receiving active cancer treatment; iv) Is currently receiving specialist survivorship care from their treating centre; v) Is currently experiencing severe difficulties that would make participation too burdensome in the clinical opinion of their treating team, or if spontaneously reported by the survivor or their family (e.g. diagnosed with current psychosis, incapacitating alcohol/drug use, suicidal ideation).
Outcome results
None listed