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

NCT05142150 | Recruiting DMC

• 1 other identifier: GCIG SB-001/NSGO-CTU-PEACE
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynaecological Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of carers who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) Lite Individualized Caregiver

  Within 42 days before patient's death

• Number of carers who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) Lite bereavement and Quality of Death and Dying (QODD) questionnaire

  Within 42 days of death up to 5-7 weeks after patient deceased.

• Number of patients who received chemotherapy and other interventions as well as palliative care

  Within 42 days before their death

• Patient satisfaction with care

  Baseline up to 5-7 weeks after patient deceased

• Carers satisfaction with care

  Baseline up to 5-7 weeks after patient deceased

Study Arms (2)

Patient

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

Other: Questionaire

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.

Other: Questionaire

Interventions

Questionaire 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; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in end of life with advanced gynaecological malignancies and their carers.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• A patient will be asked to appoint a carer.
• Age ≥ 18 years
• A relative or close friend who is actively supporting the patient in her illness
• Able (both physically and cognitively) to complete questionnaires 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 carer´s capacity to give informed consent, such as cognitive impairment, delirium, psychosis etc.

Sponsors & Collaborators

• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: lead
• Australia New Zealand Gynaecological Oncology Group: collaborator

Study Sites (1)

The Norwegian Radium Hospital

Oslo, 0310, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hematology/ biochemistry: haemoglobin, white blood cell ( WBC) Count, neutrophils, platelets, albumin, C-Reactive protein (CRP), lactate dehydrogenase (LDH), alkaline phosphatase

Central Study Contacts

Kristina Lindemann, MD, PhD

CONTACT

004722934983; klinde@ous-hf.no

Sanne Nygaard Lindberg, MSc

CONTACT

004535453398; sanne.nygaard.lindberg@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: December 2, 2021
• Study Start: January 12, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

NO (1)