None listed
Conditions
Brief summary
This study is evaluating a Centralised Specialist Cancer SurvivOrship (CISCO) Assessment Unit for people who have completed curative therapy. Who is it for? You may be eligible for this study if you have a histologically confirmed diagnosis of early breast cancer or ductal carcinoma and are completing or have recently completed chemotherapy and/or radiotherapy. Study details All participants will complete a series of questionnaires and have a consultation with a survivorship specialist team, who will provide information for ongoing cancer care and symptom management. Participants and their general practitioner will receive a care plan (called a survivorship care plan (SCP)) to easily manage their follow up care together. Supportive resources will be reviewed and pathways for contacting the oncology service will be established. Participants will be followed-up 6-12 months later and complete some questionnaires to evaluate the CISCO assessment unit. It is hoped this study will establish the feasibility and acceptability of the CISCO model and improve the transition from cancer care to primary care for patients who have completed treatment.
Interventions
This study aims to implement a dedicated specialist-led clinic that will review patients who have completed their definitive cancer treatment, and workup a comprehensive, individually-tailored, survivorship care plan (SCP). This will consist of a single amalgamated document containing 1) a chronological summary of the patient’s cancer treatment (surgery, +/- adjuvant radiotherapy and/or any systemic therapies), 2) clear recommendations for the nature and timing of follow-up investigations, 3) a list of common potential clinical issues to watch for and management thereof, 4) recommended referrals to support services, and 5) relevant oncology team contacts. The assessment process will be co-led by an oncology medical and nursing specialist. Referrals to the clinic will be electronic, and will be risk stratified based on pre-defined clinical risk, assessed by the treating Oncologist. For this study, we will be commencing with early breast cancer or ductal carcinoma-in-situ patients who are completing post-operative radiotherapy and/or chemotherapy. Patients may be commencing endocrine therapy at the time of the CISCO Unit referral / assessment. The SCP will be outlined for the patients’ GP to review and administer as necessary, with referrals to supportive wellness programs, psycho-social care or medical needs recommended, and information provided for ongoing tests, scans, follow-up schedules, as well as flagging any symptoms of concern and what to do if cancer recurrence is suspected. The assessment and/or SCP will be standardised but also individually-tailored, and built into Mosaiq, the hospital oncology electronic medical record (EMR). The CISCO Assessment Unit will be set up as an implementation trial, and will include patient, clinician and GP feedback on the information provided, GP compliance to recommendations from the CISCO consultation and the written SCP, and a review of changes in the activity type in oncology (ie if there is a shift in the patterns of specialist follow-up). The study will evaluate the outcomes and assess the feasibility and efficacy of implementing this type of cancer survivorship clinic as standard practice. Patients will be identified by their treating oncologist and/or breast nurse coordinator via clinic and/or Multi-Disciplinary Team (MDT) meeting lists to determine their eligibility to participate in the study, which will involve a referral to the CISCO Assessment Unit for a face-to-face consultation, which is ideally but not exclusively timed at the completion of definitive hospital-based treatment. the referral pathway to the CISCO Unit, incorporates a risk-stratified approach to screening and referral. Once eligible patients are identified, research staff will then mail an information and consent pack to these patients and will telephone them 2 weeks later to confirm receipt of study materials, answer any questions about participation, and initially obtain verbal consent. Patients who return a signed consent form or who provide verbal consent when phoned by research staff will be booked to attend the CISCO Assessment Unit at the Liverpool Cancer Therapy Centre. Patients who are willing to participate will be mailed their CISCO Assessment Unit consultation appointment details and also sent an sms reminder regarding the appointment 2-3 days prior. Patients who require more time to consider their participation will have the opportunity to consent at a later time and will be re-approached by phone 2 weeks later. Consenting patients will also be mailed in hard copy, or emailed an on-line link, to enable completion of the PROMPT-Care assessment measures. The psychosocial measures and assessments used in the PROMPT-Care project encompass the following validated measures : the Distress Thermometer (DT), the Edmonton Symptom Assessment Scale (ESAS), the Supportive Care Needs Survey–Screening Tool 9 (SCNS-ST9), Fear of cancer recurrence (FCR) and the quality of life scale AQOL-8D. In addition, to further characterise the study cohort, patients’ clinico-demographic, ECOG status, cancer and treatment details, as well as their treating oncology team and primary care practitioner, will be extracted from Mosaiq, the oncology EMR. Patients will be asked to complete these assessments ideally in the week prior to their CISCO Assessment Unit consultation. Tablets will also be available at the clinic for patients to complete their PROMPT-Care assessment online immediately prior to their CISCO consultation, if they have not already completed their baseline measures. Research staff will be available to assist patients who need help completing these measures. The results of the patient’s assessment will be available to the care team in real time, to be addressed in that consultation. If required, interpreters will also be present at the face-to-face consultations. Family members / carers are also welcome to attend the clinic appointments upon request from the patient. The CISCO Assessment Unit staff will include an experienced oncologist and cancer nurse coordinator who will jointly co-lead the Unit and oversee its processes and operations. At the appointment, each patient will consult sequentially with both the CISCO medical and nursing specialist, each with delegated issues to address which result from the patient’s PROMPT-Care assessment. Patients will be booked to attend both an initial 1hr consultation and at least one 30minute follow-up consultation at the CISCO Assessment Unit, scheduled 6-12 months later, depending on the patient’s survivorship care trajectory and also designed to reflect scheduled recommendations eg timing of follow-up investigations contained within their SCP so that compliance with these recommendations can be assessed. Patients will be surveyed immediately after both their initial and follow-up CISCO Assessment Unit consultations regarding their experience of the CISCO Assessment Unit and how well they thought their informational and psycho-social needs were addressed. A smaller sample of patients who have completed such surveys will be invited to participate in qualitative interviews either face-to-face or by phone, as per patient preference. After the follow-up CISCO Assessment Unit consultation is completed, patients will be assessed for appropriateness for ongoing care to occur solely with their primary care practitioner, so long as the patient, their GP and their treating oncology specialists are agreeable.
Sponsors
Study design
Eligibility
Inclusion criteria
• Histologically confirmed diagnosis of early breast cancer or Ductal Carcinoma in-situ (DCIS) • Considered appropriate for the study as per their treating oncologist based on clinico-demographic, treatment and/or psychosocial characteristics. • Have a nominated GP / primary care practitioner or practice. -Patients who have completed radiotherapy or chemotherapy under a participating clinician at the trial site.
Exclusion criteria
• Patients who are unable to complete study surveys / evaluation measures • Patients with cognitive impairment precluding study consent and study measure completion • Patients who have ongoing intensive hospital-based treatment planned