Palliation in Gynae-oncology: Patients Expectations and Assessment of Care (PEACE)

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Status: Enrolling

Conditions: Gynaecological Cancer

Treatments: Other: Questionaire

Study type: Observational

Funder types: Other

Identifiers

NCT05142150

GCIG SB-001/NSGO-CTU-PEACE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

73 participants in 2 patient groups

Patient

Description:

Patient satisfaction with end of life care. Questionnaire to be completed at baseline and every 8 week.

Treatment:

Other: Questionaire

Carer

Description:

Carer satisfaction with care leading up to the time of death and the quality of the patient's death. Questionnaire to be completed at baseline and every 8 weeks,and 5-7 weeks after patient deceased.

Treatment:

Other: Questionaire