Clinical trial NCT05142150: Palliation in Gynae-oncology: Patients Expectations and Assessment of Care (PEACE)
Official title: Palliation in Gynae-oncology: Patients Expectations and Assessment of Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynaecological Cancer
Lead sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Sponsor class: OTHER
Collaborators: name: Australia New Zealand Gynaecological Oncology Group
First posted: 2021-12-02
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in end of life with advanced gynaecological malignancies and their carers.

Brief summary: 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.

Detailed description: Prospective observational cohort study.

Little is known about end of life care (EOL) in patients with ovarian or other gynaecological cancers. Patients typically have a high symptom burden and following several prior lines of therapy or the development of platinum resistant disease response rates to further active treatment are limited. Eliciting patients' values and preferences for end-of-life care and shared decision-making are central elements of patient-centered EOL care. The aim of this study is to assess the feasibility of collecting data on patient satisfaction towards end of life. Preliminary data on patient and carer satisfaction with care, the importance of aspects of care, as well as end of life treatment will also be collected. The study will also assess the carer satisfaction with care during bereavement and with the patient's dying experience.

The study will recruit beyond the targeted number of 73 patients number if the study is progressing favourably. Ideally, each patient will nominate a carer to also complete questionnaires and the carer will be able to assist in completing the diary, although this is not mandatory.

Eligibility 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 ≥ 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.

Primary outcomes:
measure: Number of patients who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) instrument, CANHELP Lite Individualised version
timeFrame: Within 42 days before their death
Secondary outcomes:
measure: Number of carers who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) Lite Individualized Caregiver
timeFrame: Within 42 days before patient's death
measure: Number of carers who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) Lite bereavement and Quality of Death and Dying (QODD) questionnaire
timeFrame: Within 42 days of death up to 5-7 weeks after patient deceased.
measure: Number of patients who received chemotherapy and other interventions as well as palliative care
timeFrame: Within 42 days before their death
measure: Patient satisfaction with care
timeFrame: Baseline up to 5-7 weeks after patient deceased
measure: Carers satisfaction with care
timeFrame: Baseline up to 5-7 weeks after patient deceased
measure: The importance of aspects of care for patients
timeFrame: Baseline up to 5-7 weeks after patient deceased
measure: The importance of aspects of care for carers
timeFrame: Baseline up to 5-7 weeks after patient deceased
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Radium Hospital
Study officials:
References: