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

NCT ID: NCT05142150

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2027-12-31

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.

Conditions

Gynaecological Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient

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

Questionaire

Intervention Type: OTHER

Patient 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.

Carer

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.

Questionaire

Intervention Type: OTHER

Patient 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.

Interventions

Questionaire

Patient 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.

Intervention Type: OTHER

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).

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

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Australia New Zealand Gynaecological Oncology Group

OTHER

Sponsor Role: collaborator

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Norwegian Radium Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Kristina Lindemann, MD, PhD

Role: CONTACT

klinde@ous-hf.no

004722934983

Sanne Nygaard Lindberg, MSc

Role: CONTACT

sanne.nygaard.lindberg@regionh.dk

004535453398

Facility Contacts

Kristina Lindemann, MD, PhD

Role: primary

klinde@ous-hf.no

+47 22934000 ext. 5690

Other Identifiers

GCIG SB-001/NSGO-CTU-PEACE

Identifier Type: -

Identifier Source: org_study_id