None listed
Conditions
Brief summary
This study will investigate the feasibility of collecting data on the satisfaction of end of life care from patients with advanced gynaecological malignancies. Who is it for? You may be eligible to join this study if you are aged 18 and above, have advanced gynaecological malignancy and a life expectancy of approximately 4 months as estimated by your treating physician. Study details All participants and their carers in this study will be asked to answer questionnaires about their experiences with the palliative care process, satisfaction with care and symptom management towards end of life. Patients and carers are expected to complete questionnaires at screening and every 8 weeks until the death of the patient. It is hoped that this research can provide preliminary insight on the satisfaction and expectations of care of patients with advanced gynaecological cancer, to inform future research aimed at understanding these issues fully and addressing unmet needs.
Interventions
The main purpose of this study is to determine the feasibility of collecting information from women with advanced gynaecological cancer about their experiences, satisfaction with care and symptom management towards end of life. The research being conducted is via the use of questionnaires completed by participants, and if available their carer. The questionnaires are focusing on how both patients and their carers are feeling about the palliative care process and the care they are receiving. Pati
The main purpose of this study is to determine the feasibility of collecting information from women with advanced gynaecological cancer about their experiences, satisfaction with care and symptom management towards end of life. The research being conducted is via the use of questionnaires completed by participants, and if available their carer. The questionnaires are focusing on how both patients and their carers are feeling about the palliative care process and the care they are receiving. Patients and carers are expected to complete questionnaires until the death of the patient. As only patients with advanced gynaecological cancer and a predicted life expectancy of ~4 months will be considered potentially suitable for the study, participation to the study is expected to be for ~4 months. At screening, information about the patient’s cancer diagnosis, previous or current cancer treatments, involvement of palliative/supportive care, and general demographic data will be collected. A blood test will also be performed. Patients will complete EORTC QLQ PAL15 at screening, CANHELP Lite Individualised Version (all domains) at screening and every 8 weeks, FACIT-TS-PS (1 domain: treatment and staff communication) at screening and every 8 weeks. CANHELP Lite Individualised Version (3 domains: illness management, communication, decision making) will be completed if a trigger event occurs such as ceasing anti-cancer therapy, change in anti-cancer treatment and or during/at discharge of unplanned hospital admissions. Patients will also keep a diary online to record any admissions to hospital or hospice, presentations to the emergency department, involvement with health care teams, or any procedures performed. At screening, general demographic data will by collection from carers. Carers will complete the CANHELP Carer Lite Individualised at screening and every 8 weeks, and the CANHELP Bereavement Lite and Quality of Death and Dying 6 weeks after bereavement. Questionnaires and diaries will be completed online on the electronic platform CANKADO on a smart phone, iPad or other device.
Sponsors
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria A patient will be eligible for inclusion only if all of the following criteria are fulfilled: 1. Patients with any advanced gynecological malignancy and a life expectancy of approximately 4 months as estimated by their treating physician*. Potential patient groups include, but are not limited to, those with platinum-resistant/refractory recurrent epithelial ovarian cancer (PRR-EOC), metastatic/recurrent cervical or endometrial cancer progressing after platinum-based chemotherapy; high grade/undifferentiated metastatic uterine sarcoma progressing after first-line chemotherapy etc. 2. Patients may be on active cancer treatment, about to commence active cancer treatment or under observation/palliative care. 3. Age greater than or equal to 18 years. 4. Able (both physically and cognitively) to complete patient-reported outcome measures independently in languages that are available in this study (i.e. without assistance from hospital translator). *Estimated life expectancy is defined as the estimated median survival time in a group of similar patients. Based on our previous research, patients with an estimated life expectancy of approximately 4 months have a 5-10% probability of surviving beyond 12 months. A patient will be asked to appoint a carer. Inclusion criteria carer 1. Age greater than or equal to 18 years. 2. A relative or close friend who is actively supporting the patient in her illness 3. Able (both physically and cognitively) to complete questionnaires independently in languages that are available in this study (i.e. without assistance from hospital translator).
Exclusion criteria
Exclusion criteria A patient will not be eligible for inclusion if any of the following criteria are fulfilled: 1. Unable to be comply with the protocol 2. A medical or psychological condition that limits the patient´s capacity to give informed consent, such as cognitive impairment, delirium, psychosis etc. 3. Participation in another clinical trial Exclusion criteria carer A carer will not be eligible for inclusion if any of the following criteria are fulfilled: 1. Unable to be comply with the protocol 2. A medical or psychological condition that limits the carer´s capacity to give informed consent, such as cognitive impairment, delirium, psychosis etc.
Outcome results
None listed