Gynaecological Cancer Clinical Trial
— PEACEOfficial title:
Palliation in Gynae-oncology: Patients Expectations and Assessment of Care
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.
Status | Recruiting |
Enrollment | 73 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 = 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). 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. A patient will be asked to appoint a carer. Inclusion criteria carer: 1. Age = 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 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. |
Country | Name | City | State |
---|---|---|---|
Norway | The Norwegian Radium Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Australia New Zealand Gynaecological Oncology Group |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Within 42 days before their death | |
Secondary | 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). | Within 42 days before patient's death | |
Secondary | 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. | Within 42 days of death up to 5-7 weeks after patient deceased. | |
Secondary | 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 | Within 42 days before their death | |
Secondary | 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. | Baseline up to 5-7 weeks after patient deceased | |
Secondary | Carers satisfaction with care | Satisfaction will be assessed with CANHELP Lite bereavement and quality of death and dying (QODD) questionnaire.
The QODD questionnaire has 24 items that assess various aspects of dying and death including whether the patient's symptoms were adequately controlled, whether dignity was maintained, time spent with loved ones in days leading up to death and whether the patient's wishes were adhered to. The QODD questionnaire also contains 14 additional items that assess the cargiver's demographic characteristics and relation to the deceased. The 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. |
Baseline up to 5-7 weeks after patient deceased | |
Secondary | The importance of aspects of care for patients | Importance of aspects of care will be assessed through CANHELP Lite. | Baseline up to 5-7 weeks after patient deceased | |
Secondary | The importance of aspects of care for carers | Importance of aspects of care assessed through CANHELP Lite. | Baseline up to 5-7 weeks after patient deceased |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05918770 -
Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
|
N/A | |
Completed |
NCT04379232 -
Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center
|
||
Recruiting |
NCT03580109 -
Spa Therapy for Upper or Lower Limb Lymphoedema
|
N/A | |
Recruiting |
NCT04839874 -
Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes?
|
||
Completed |
NCT02275403 -
Standard Care Alone or With Acupuncture for CIPN in Breast Cancer and Multiple Myeloma
|
Phase 2 |