Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01885637
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2013-06-17
Brief Title:
DOMUS A Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
DOMUS A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOMUS
Brief Summary:
Danish studies have shown that the majority of palliative cancer patients wish to be cared for and spend the rest of their lives at home Nevertheless 50 of palliative cancer patients die in acute hospitals and these figures are found in countries with a highly developed palliative care service as well Some studies have suggested that among other causes delays in the discharge process represent a significant obstacle for achieving care and treatment and ultimately death at home Therefore this randomized controlled trial RCT aims at investigating an accelerated transition program from oncological treatment to continuous specialized palliative care at home for patients with incurable cancer The primary objective of the study is to investigate whether an accelerated transition from oncology care to palliative home care significantly increases home care and death The secondary objectives are to investigate whether the intervention improves symptom control and quality of life increases survival affects health care expenses improves caregiver quality of life and burden dyadic coping and grief outcomes The study will take place in the departments of oncology at Rigshospitalet where palliative cancer patients will enter the intervention or usual care arms The intervention is an accelerated transition program which consists of planning palliative home care and if needed optimization of facilities at home and a transfer to home care within 5 days of informed consent On day 1 at home the patient informal caregiver nurse representatives of the specialized palliative care team and if possible the general practitioner and project psychologist meet to organize home care A dyadic psychological intervention is offered to patients and their informal caregiver during specialized palliative care at home and to bereaved caregivers The control group will be treated according to the usual principles but if inadequate palliative care is observed in this group the study group is obliged to involve responsible professionals Both groups will be followed by assessments of the patient and the caregiver for up to 6 months and the caregivers 19 month after the patients death
Detailed Description:
The trial is a controlled randomized clinical trial in which 340 in- and outpatients in the Department of Oncology at Rigshospitalet Copenhagen University Hospital are randomly assigned to either an accelerated transition process from oncological treatment to continuing specialised palliative care SPC at home plus standard care or standard care alone
Patients are randomized immediately after their consent and will be discharged within a maximum of 5 working days from randomization If these timelines are exceeded due to practical issues the patient can participate in the trial if heshe completes a new base-line questionnaire Quality of life questionnaire - Core EORTC-QLQ-C30 Edmonton Symptom Assessment System revised version ESAS-r Hospital Anxiety and Depression Scale HADS Symptoms priority list Symptom Checklist-92 SCL-92 Medical Outcomes Study Social Support Survey mMOS-SS Dyadic Coping Inventory DCIand Relationship ladder and still meets the inclusion criteria
Data collection from patients and informal caregivers
Patients are identified informed about the study and consenting patients and their informal caregivers complete questionnaires baseline after which patients are randomized to either the intervention or the control group The intervention group will be assigned a specialised palliative care team SPT no later than 5 days after randomization The control group will continue their current treatment Two weeks after baseline patients and caregivers complete questionnaires for the 2-week follow-up Likewise the follow-up at 4 and 8-weeks consists of questionnaires completed by patients and caregivers Six months after baseline the patients vital status is retrieved If the patient is still alive questionnaires are sent to the patient and caregiver
In case of admissions of the patients in both groups data regarding causes of admission are retrieved from medical records
Throughout the psychological intervention the psychologists will register the thematic content of the sessions
Data collection from informal caregivers includes the Medical Outcomes Study SF-36 Symptom Checklist-92 SCL-92 modified Medical Outcomes Study Social Support Survey mMOS-SSS Zarit Burden Interview ZBI Dyadic Coping Inventory DCI Relationship Ladder and Experiences in Close Relationships-Short Form ECR-S Data collection from caregivers will continue after the patients death in the form of questionnaires which are to be completed after 14 days 2 7 13 and 19 months into the bereavement process Medical Outcomes Study SF-36 Symptom Checklist-92 SCL-92Pittsburgh Sleep Quality index PSQI modified Medical Outcomes Study Social Support Survey mMOS-SSS Inventory of Daily Widowed Life IDWL Experiences in Close Relationships-Short Form and Prolonged GriefPG-13 Further data on caregivers use of healthcare services will be retrieved from the National Health Care Register National Patient Registry the Psychiatric Central Register and Medicinal Product Statistics Register After the last session short semi-structured interviews will be conducted among a selected group of caregivers to identify the elements of the intervention that were experienced as helpful and to investigate the caregivers experience of having cared for their relatives at home and their bereavement process
Blood samples from a subgroup of caregivers
To analyze Telomere length 10-milliliter ml blood samples from caregivers will be collected in a heparinized glass before and after the intervention The white blood cells leukocytes are isolated and frozen to - 80 degrees Celsius Blood samples are taken before randomization and after termination of the intervention When the investigation is complete and all blood samples have been obtained and frozen we will follow a standard protocol for isolation of telomere DNA This protocol describes how DNA is analyzed for TL in the leukocytes by using a quantitative polymerase chain reaction PCR and how the total average TL is calculated from both the amount of telomeric product and each copy gene
The intervention
1 Before the patient agrees to participate an information meeting will be held If the patient gives consent to participate the CRFs will be completed the blood sample taken from the caregiver and the patient will be randomized
2 At day one or two after randomization the research nurse the patient and informal caregiver discuss the patients wishes for specialised palliative care in their own home and how these can be reconciled with the caregivers wishes The patient and caregivers perceptions of challenges and concerns related to home care are explored and addressed
3 Immediately after the planning meeting the conditions in the home are optimized if needed
4 Four to five days after randomization a home conference is held with the patient and caregiver representatives of the SPT nurse and as far as possible with the patients GP and the project psychologist The SPT in collaboration with the GP and district nursing is now responsible for the distribution of tasks related to treatment and care
5 Patient and caregiver the primary informal caregiver appointed by the patient will be offered a psychological intervention as part of the multi-disciplinary intervention The psychological intervention will be guided by an intervention manual developed specifically for the study After the patients death bereaved caregivers will be offered one or two additional session concluding the intervention
Elements of the psychological intervention
The psychological intervention will provide a continuum of sessions both before and after the patients death so caregivers continue to be supported after the death of their loved ones The session content will depend on the specific situation and needs of each patient-caregiver dyad The sessions may thus address several themes that can support the patient in being at home for example communication between the patient and the caregiver reconciliation of different expectations and wishes for being cared for at home psycho-education about stress and coping and focus on caregivers self-care The psychologist may also serve as a navigator in the event of unresolved issues and problems ie help patients and caregivers to identify the most important issues for them and the right people to contact
The duration of the study
The study is completed when 340 patients have been randomized into the study and after the last patient has been followed six months after baseline Patients in the intervention group can then choose to continue with the SPT after the study completion
Duration of the study of caregivers ranges from randomization to the end of follow-up 19 months after the death of the patient
In the control group the patients continue to be attached to the health care system in line with current practice This means that the patient typically remains in hospital or ambulatory clinic and may have contact with one or more hospitals GP and possibly homecare later in the process Caregivers in the control group may receive psychological counseling through referral from a GP
Patients are randomized immediately after their consent and will be discharged within a maximum of 5 working days from randomization If these timelines are exceeded due to practical issues the patient can participate in the trial if heshe completes a new base-line questionnaire Quality of life questionnaire - Core EORTC-QLQ-C30 Edmonton Symptom Assessment System revised version ESAS-r Hospital Anxiety and Depression Scale HADS Symptoms priority list Symptom Checklist-92 SCL-92 Medical Outcomes Study Social Support Survey mMOS-SS Dyadic Coping Inventory DCIand Relationship ladder and still meets the inclusion criteria
Data collection from patients and informal caregivers
Patients are identified informed about the study and consenting patients and their informal caregivers complete questionnaires baseline after which patients are randomized to either the intervention or the control group The intervention group will be assigned a specialised palliative care team SPT no later than 5 days after randomization The control group will continue their current treatment Two weeks after baseline patients and caregivers complete questionnaires for the 2-week follow-up Likewise the follow-up at 4 and 8-weeks consists of questionnaires completed by patients and caregivers Six months after baseline the patients vital status is retrieved If the patient is still alive questionnaires are sent to the patient and caregiver
In case of admissions of the patients in both groups data regarding causes of admission are retrieved from medical records
Throughout the psychological intervention the psychologists will register the thematic content of the sessions
Data collection from informal caregivers includes the Medical Outcomes Study SF-36 Symptom Checklist-92 SCL-92 modified Medical Outcomes Study Social Support Survey mMOS-SSS Zarit Burden Interview ZBI Dyadic Coping Inventory DCI Relationship Ladder and Experiences in Close Relationships-Short Form ECR-S Data collection from caregivers will continue after the patients death in the form of questionnaires which are to be completed after 14 days 2 7 13 and 19 months into the bereavement process Medical Outcomes Study SF-36 Symptom Checklist-92 SCL-92Pittsburgh Sleep Quality index PSQI modified Medical Outcomes Study Social Support Survey mMOS-SSS Inventory of Daily Widowed Life IDWL Experiences in Close Relationships-Short Form and Prolonged GriefPG-13 Further data on caregivers use of healthcare services will be retrieved from the National Health Care Register National Patient Registry the Psychiatric Central Register and Medicinal Product Statistics Register After the last session short semi-structured interviews will be conducted among a selected group of caregivers to identify the elements of the intervention that were experienced as helpful and to investigate the caregivers experience of having cared for their relatives at home and their bereavement process
Blood samples from a subgroup of caregivers
To analyze Telomere length 10-milliliter ml blood samples from caregivers will be collected in a heparinized glass before and after the intervention The white blood cells leukocytes are isolated and frozen to - 80 degrees Celsius Blood samples are taken before randomization and after termination of the intervention When the investigation is complete and all blood samples have been obtained and frozen we will follow a standard protocol for isolation of telomere DNA This protocol describes how DNA is analyzed for TL in the leukocytes by using a quantitative polymerase chain reaction PCR and how the total average TL is calculated from both the amount of telomeric product and each copy gene
The intervention
1 Before the patient agrees to participate an information meeting will be held If the patient gives consent to participate the CRFs will be completed the blood sample taken from the caregiver and the patient will be randomized
2 At day one or two after randomization the research nurse the patient and informal caregiver discuss the patients wishes for specialised palliative care in their own home and how these can be reconciled with the caregivers wishes The patient and caregivers perceptions of challenges and concerns related to home care are explored and addressed
3 Immediately after the planning meeting the conditions in the home are optimized if needed
4 Four to five days after randomization a home conference is held with the patient and caregiver representatives of the SPT nurse and as far as possible with the patients GP and the project psychologist The SPT in collaboration with the GP and district nursing is now responsible for the distribution of tasks related to treatment and care
5 Patient and caregiver the primary informal caregiver appointed by the patient will be offered a psychological intervention as part of the multi-disciplinary intervention The psychological intervention will be guided by an intervention manual developed specifically for the study After the patients death bereaved caregivers will be offered one or two additional session concluding the intervention
Elements of the psychological intervention
The psychological intervention will provide a continuum of sessions both before and after the patients death so caregivers continue to be supported after the death of their loved ones The session content will depend on the specific situation and needs of each patient-caregiver dyad The sessions may thus address several themes that can support the patient in being at home for example communication between the patient and the caregiver reconciliation of different expectations and wishes for being cared for at home psycho-education about stress and coping and focus on caregivers self-care The psychologist may also serve as a navigator in the event of unresolved issues and problems ie help patients and caregivers to identify the most important issues for them and the right people to contact
The duration of the study
The study is completed when 340 patients have been randomized into the study and after the last patient has been followed six months after baseline Patients in the intervention group can then choose to continue with the SPT after the study completion
Duration of the study of caregivers ranges from randomization to the end of follow-up 19 months after the death of the patient
In the control group the patients continue to be attached to the health care system in line with current practice This means that the patient typically remains in hospital or ambulatory clinic and may have contact with one or more hospitals GP and possibly homecare later in the process Caregivers in the control group may receive psychological counseling through referral from a GP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007--58--0015 | OTHER | The Danish Data Protection Agency | None |