Gynaecological CancerPEACENCT05142150
Palliation in Gynae-oncology: Patients Expectations and Assessment of Care (PEACE)
An observational study of Gynaecological Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynaecological Cancer
- What is being tested?
- Questionaire
- How many people
- 73 participants
- Where
- 1 siteNorway
- Study dates
- 12 Jan 2023to 31 Dec 2027
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients in end of life with advanced gynaecological malignancies and their carers.
Who may be able to join
- A patient will be eligible for inclusion only if all of the following criteria are fulfilled:
- 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).
- 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).
Who cannot join
- A patient will not be eligible for inclusion if any of the following criteria are fulfilled:
- 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.
- A carer will not be eligible for inclusion if any of the following criteria are fulfilled:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
The Norwegian Radium Hospital
Oslo, 0310
Kristina Lindemann, MD, PhD, +47 22934000 ext. 5690, klinde@ous-hf.no
Kristina Lindemann, MD, PhD
About this study
Official title: Palliation in Gynae-oncology: Patients Expectations and Assessment of Care
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.
Read the 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
- Being tested
- Questionaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patient satisfaction with end of life care. Questionnaire to be completed at baseline and every 8 week. Receives: 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. Receives: Other: Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
To study the feasibility of collecting data on carer 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).
Measured: 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
To study the feasibility of collecting data on carer satisfaction with care leading up to the time of death and the quality of the patient´s death. CANHELP response options range from 1'not at all satisfied' to 5 'completely satisfied', with an overall satisfaction with care score and scores on each individual domains. All scores are re-scaled to range 0 (worst possible value) to 100 (best possible value). The QODD questionnaire has 24 items that assess aspects of dying and death. The QODD questionnaire contains 14 additional items that assess cargiver's demographic characteristics and relation to the deceased. Response options for each item are rated on a scale from 0 (terrible) to 10 (almost perfect). The items provide a single score, derived as a mean of the item values, transformed to a 0 to 100 scale.
Measured: 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
To study use of chemotherapy, surgical interventions as well as palliative care involvement
Measured: Within 42 days before their death
Patient satisfaction with care
Patient satisfaction will be assessed with CANHELP Lite Individualized. In all CANHELP Lite versions response options for each item range from 1'not at all satisfied' to 5 'completely satisfied' . A 'not applicable/not discussed' response option for items that patients/cares felt was not relevant to their situation. 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). The questionnaires will be administered and scored in accordance with the user manual.
Measured: Baseline up to 5-7 weeks after patient deceased
Carers satisfaction with care
Satisfaction will be assessed with CANHELP Lite bereavement and quality of death and dying (QODD) questionnaire.
The QODD questionnaire has 24 items that assess various aspects of dying and death including whether the patient's symptoms were adequately controlled, whether dignity was maintained, time spent with loved ones in days leading up to death and whether the patient's wishes were adhered to. The QODD questionnaire also contains 14 additional items that assess the cargiver's demographic characteristics and relation to the deceased. The response options for each item are rated on a scale from 0 (terrible) to 10 (almost perfect). The items provide a single score, derived as a mean of the item values, transformed to a 0 to 100 scale.
Measured: Baseline up to 5-7 weeks after patient deceased
The importance of aspects of care for patients
Importance of aspects of care will be assessed through CANHELP Lite.
Measured: Baseline up to 5-7 weeks after patient deceased
The importance of aspects of care for carers
Importance of aspects of care assessed through CANHELP Lite.
Measured: Baseline up to 5-7 weeks after patient deceased
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start12 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecological CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Australia New Zealand Gynaecological Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142150
- Sponsor's protocol ID
- GCIG SB-001/NSGO-CTU-PEACE
- Acronym
- PEACE
- Status last verified
- Sep 2024
- First submitted
- 8 Oct 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliation in Gynae-oncology: Patients Expectations and Assessment of Care
- ClinicalTrials.gov ID
- NCT05142150
- Acronym / sponsor ID
- PEACE / GCIG SB-001/NSGO-CTU-PEACE
- Conditions
- Gynaecological Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Collaborators
- Australia New Zealand Gynaecological Oncology Group
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: QuestionairePatient satisfaction with end of life care. Questionnaire to be completed at baseline and every 8 week. |
| Carer | – | Other: QuestionaireCarer 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in end of life with advanced gynaecological malignancies and their carers.
Key inclusion criteria (8 listed)
- A patient will be eligible for inclusion only if all of the following criteria are fulfilled:
- 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).
Key exclusion criteria (8 listed)
- A patient will not be eligible for inclusion if any of the following criteria are fulfilled:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionairePatient 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. | Other | Carer, Patient |
Primary outcome
Number of patients who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) instrument, CANHELP Lite Individualised version
Time frame: Within 42 days before their death
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).
7 secondary outcomes
Number of carers who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) Lite Individualized Caregiver
Time frame: 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
Time frame: 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
Time frame: Within 42 days before their death
Patient satisfaction with care
Time frame: Baseline up to 5-7 weeks after patient deceased
Carers satisfaction with care
Time frame: Baseline up to 5-7 weeks after patient deceased
The importance of aspects of care for patients
Time frame: Baseline up to 5-7 weeks after patient deceased
The importance of aspects of care for carers
Time frame: Baseline up to 5-7 weeks after patient deceased
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynaecological Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Lindemann, MD, PhD (004722934983, klinde@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who complete scheduled assessments with Canadian Health Care Evaluation Project (CANHELP) instrument, CANHELP Lite Individualised version (time frame: Within 42 days before their death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.