The overall aim is to assess the feasibility and acceptability of collecting data on the patients and carers perception of care as well as to prospectively monitor end of life care.
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.
Patients may be on active cancer treatment, about to commence active cancer treatment or under observation/palliative care.
Age ≥ 18 years
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).
Unable to be comply with the protocol.
A medical or psychological condition that limits the patient´s capacity to give informed consent, such as cognitive impairment, delirium, psychosis etc.
Participation in another clinical trial.
Age ≥ 18 years
Patients in end of life with advanced gynaecological malignancies and their carers.
Cohort
Prospective
Questionaire
Other interventionPatient questionaires collecting data on quality of life, illness management, communication and decision making. Patient report data of end of life care ( i.e administration of chemotherapy, surgical interventions, palliative care involvement, hospital admissions) through as self reported diary. Carer for patients questionnaires their satisfaction with care. 5-7 weeks after patient deceased carer completes bereavement questionnaire and quality of death and dying.
Number of patients who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) instrument, CANHELP Lite Individualised version
To study the feasibility of collecting data on patient satisfaction with care. In all CANHELP Lite versions response options for each item range from 1'not at all satisfied' to 5 'completely satisfied'. All versions have an overall satisfaction with care score, as well as scores on each of the individual domains. All scores are re-scaled to range between 0 (worst possible value) to 100 (best possible value).
Number of carers who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) Lite Individualized Caregiver
To study the feasibility of collecting data on carer satisfaction with care. In all CANHELP Lite versions response options for each item range from 1'not at all satisfied' to 5 'completely satisfied'. All versions have an overall satisfaction with care score, as well as scores on each of the individual domains. All scores are re-scaled to range between 0 (worst possible value) to 100 (best possible value).
Number of carers who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) Lite bereavement and Quality of Death and Dying (QODD) questionnaire
To study the feasibility of collecting data on carer satisfaction with care leading up to the time of death and the quality of the patient´s death. CANHELP response options range from 1'not at all satisfied' to 5 'completely satisfied', with an overall satisfaction with care score and scores on each individual domains. All scores are re-scaled to range 0 (worst possible value) to 100 (best possible value). The QODD questionnaire has 24 items that assess aspects of dying and death. The QODD questionnaire contains 14 additional items that assess cargiver's demographic characteristics and relation to the deceased. Response options for each item are rated on a scale from 0 (terrible) to 10 (almost perfect). The items provide a single score, derived as a mean of the item values, transformed to a 0 to 100 scale.
Number of patients who received chemotherapy and other interventions as well as palliative care
To study use of chemotherapy, surgical interventions as well as palliative care involvement
Patient satisfaction with care
Patient satisfaction will be assessed with CANHELP Lite Individualized. In all CANHELP Lite versions response options for each item range from 1'not at all satisfied' to 5 'completely satisfied' . A 'not applicable/not discussed' response option for items that patients/cares felt was not relevant to their situation. All versions have an overall satisfaction with care score, as well as scores on each of the individual domains. All scores are re-scaled to range between 0 (worst possible value) to 100 (best possible value). The questionnaires will be administered and scored in accordance with the user manual.
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Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Lead sponsor
Australia New Zealand Gynaecological Oncology Group
Collaborator
