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Trial registered on ANZCTR


Registration number
ACTRN12621001031853
Ethics application status
Approved
Date submitted
28/06/2021
Date registered
5/08/2021
Date last updated
5/08/2021
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
PEACE – Palliation in Gynae-oncology: Patient Expectations and Assessment of Care
Scientific title
PEACE – Palliation in Gynae-oncology: Patient Expectations and Assessment of Care
Secondary ID [1] 304465 0
ANZGOG Protocol Number - ANZGOG1923/2020
Universal Trial Number (UTN)
N/A
Trial acronym
PEACE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Gynaecological Cancer 322287 0
Condition category
Condition code
Cancer 319965 319965 0 0
Cervical (cervix)
Cancer 319966 319966 0 0
Ovarian and primary peritoneal
Cancer 319967 319967 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The main purpose of this study is to determine the feasibility of collecting information from women with advanced gynaecological cancer about their experiences, satisfaction with care and symptom management towards end of life. The research being conducted is via the use of questionnaires completed by participants, and if available their carer. The questionnaires are focusing on how both patients and their carers are feeling about the palliative care process and the care they are receiving. Patients and carers are expected to complete questionnaires until the death of the patient. As only patients with advanced gynaecological cancer and a predicted life expectancy of ~4 months will be considered potentially suitable for the study, participation to the study is expected to be for ~4 months.
At screening, information about the patient’s cancer diagnosis, previous or current cancer treatments, involvement of palliative/supportive care, and general demographic data will be collected. A blood test will also be performed. Patients will complete EORTC QLQ PAL15 at screening, CANHELP Lite Individualised Version (all domains) at screening and every 8 weeks, FACIT-TS-PS (1 domain: treatment and staff communication) at screening and every 8 weeks. CANHELP Lite Individualised Version (3 domains: illness management, communication, decision making) will be completed if a trigger event occurs such as ceasing anti-cancer therapy, change in anti-cancer treatment and or during/at discharge of unplanned hospital admissions. Patients will also keep a diary online to record any admissions to hospital or hospice, presentations to the emergency department, involvement with health care teams, or any procedures performed.
At screening, general demographic data will by collection from carers. Carers will complete the CANHELP Carer Lite Individualised at screening and every 8 weeks, and the CANHELP Bereavement Lite and Quality of Death and Dying 6 weeks after bereavement. Questionnaires and diaries will be completed online on the electronic platform CANKADO on a smart phone, iPad or other device.
Intervention code [1] 320812 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327845 0
Proportion of patients who complete scheduled assessments with CANHELP Lite Individualized within 42 days of death.
Timepoint [1] 327845 0
Assessed at screening, and every 8 weeks until death.
Secondary outcome [1] 396742 0
Proportion of carers who complete scheduled assessment with CANHELP Lite Individualized Caregiver within 42 days before patient's death.
Timepoint [1] 396742 0
Assessed at screening, and every 8 weeks until death of patient.
Secondary outcome [2] 396743 0
Proportion of carers who complete scheduled assessment with CANHELP Lite Bereavement and Quality of Death and Dying Questionnaire.
Timepoint [2] 396743 0
Assessed at 6 weeks (+/- 1 week) after patient's death.
Secondary outcome [3] 399249 0
Patients’ satisfaction with care. Assessed by completion of CANHELP Lite Individualised Version, FACIT-TS-PS, 1 domain: treatment and staff communication.
Timepoint [3] 399249 0
Assessed at screening, and every 8 weeks until patient's death.
Secondary outcome [4] 399250 0
Carers’ satisfaction with care. Assessed by completion of CANHELP Carer Lite Individualised Version.
Timepoint [4] 399250 0
Assessed at screening, and every 8 weeks until patient's death.
Secondary outcome [5] 399251 0
Patient’s assessment of importance of aspects of care. Assessed by the completion of CANHELP Lite Individualised Version, FACIT-TS-PS, 1 domain: treatment and staff communication.
Timepoint [5] 399251 0
Assessed at screening, and every 8 weeks until patient's death.
Secondary outcome [6] 399252 0
Carer’s assessment of importance of aspects of care. Assessed by the completion of CANHELP Carer Lite Individualised Version.
Timepoint [6] 399252 0
Assessed at screening, and every 8 weeks until patient's death.

Eligibility
Key inclusion 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 greater than or equal to 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).

*Estimated life expectancy is defined as the estimated median survival time in a group of similar patients. Based on our previous research, patients with an estimated life expectancy of approximately 4 months have a 5-10% probability of surviving beyond 12 months.

A patient will be asked to appoint a carer.
Inclusion criteria carer
1. Age greater than or equal to 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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

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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 19731 0
The Canberra Hospital - Garran
Recruitment hospital [2] 19732 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [3] 20136 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 34369 0
2605 - Garran
Recruitment postcode(s) [2] 34370 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 34857 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 23775 0
Norway
State/province [1] 23775 0

Funding & Sponsors
Funding source category [1] 308823 0
Hospital
Name [1] 308823 0
Private Practice Fund Minor Grants (Canberra Hospital)
Address [1] 308823 0
Building 23, Level 2
Yamba Drive, Garran ACT 2605
Country [1] 308823 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address
Level 6, Chris O’Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 309740 0
Other Collaborative groups
Name [1] 309740 0
Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU)
Address [1] 309740 0
Nordic Society of Gynaecological Oncology -
Department of Oncology, 9431
Rigshospitalet
Copenhagen University Hospital
Blegdamsvej 60, 2100 Copenhagen
Country [1] 309740 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308736 0
Sydney Local Health District Human Research Ethics Committee – RPAH Zone
Ethics committee address [1] 308736 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Campberdown NSW 2050
Ethics committee country [1] 308736 0
Australia
Date submitted for ethics approval [1] 308736 0
23/02/2021
Approval date [1] 308736 0
27/04/2021
Ethics approval number [1] 308736 0
X21-0051 & 2021/ETH00320

Summary
Brief summary
This study will investigate the feasibility of collecting data on the satisfaction of end of life care from patients with advanced gynaecological malignancies.

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have advanced gynaecological malignancy and a life expectancy of approximately 4 months as estimated by your treating physician.

Study details
All participants and their carers in this study will be asked to answer questionnaires about their experiences with the palliative care process, satisfaction with care and symptom management towards end of life. Patients and carers are expected to complete questionnaires at screening and every 8 weeks until the death of the patient.

It is hoped that this research can provide preliminary insight on the satisfaction and expectations of care of patients with advanced gynaecological cancer, to inform future research aimed at understanding these issues fully and addressing unmet needs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111710 0
Dr Alison Davis
Address 111710 0
Canberra Hospital
Yamba Drive, Garran ACT 2605
Country 111710 0
Australia
Phone 111710 0
+61 2 5124 2220
Fax 111710 0
Email 111710 0
alison.davis@act.gov.au
Contact person for public queries
Name 111711 0
Dr Alison Davis
Address 111711 0
Canberra Hospital
Yamba Drive, Garran ACT 2605
Country 111711 0
Australia
Phone 111711 0
+61 2 5124 2220
Fax 111711 0
Email 111711 0
alison.davis@act.gov.au
Contact person for scientific queries
Name 111712 0
Dr Alison Davis
Address 111712 0
Canberra Hospital
Yamba Drive, Garran ACT 2605
Country 111712 0
Australia
Phone 111712 0
+61 2 5124 2220
Fax 111712 0
Email 111712 0
alison.davis@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual Participant Data will not be made available, as participant data is coded for privacy reasons.
What supporting documents are/will be available?
No other documents available
Summary results
No Results