Incurable CancerDOMUSNCT01885637
DOMUS: A Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
A study testing Transition program in people with Incurable Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incurable Cancer
- What is being tested?
- Transition program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (at least 18 year old) cancer patients connected to the Department of Oncology, Copenhagen University Hospital
- Patients who want to spend as much time as possible in their own homes supported by an SPT
- Patients with incurable cancer
- Patients with no or limited antineoplastic treatment options or patients who resign antineoplastic treatment
- Patients living in the Capital Region
- Written informed consent
Who cannot join
- Patients who have already been referred to an SPT
- Hospitalized patients who are not judged capable of being discharged home
- Patients who are admitted to other hospitals
- Patients who do not speak Danish well enough to answer the questionnaires
- Patients who are considered incapable of cooperating in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
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 patient's death.
Read the 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 he/she 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 (DCI)and 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 patient's 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 patient's 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-92),Pittsburgh 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 Grief(PG-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:
- 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.
- At day one or two after randomization the research nurse, the patient and informal caregiver discuss the patient's wishes for specialised palliative care in their own home and how these can be reconciled with the caregiver's wishes. The patient and caregiver's perceptions of challenges and concerns related to home care are explored and addressed.
- Immediately after the planning meeting the conditions in the home are optimized, if needed.
- 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 patient's 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.
- 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 patient's 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 patient's 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 (i.e. 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.
- Conditions
- Incurable Cancer
- Being tested
- Transition program
- Keywords
- Palliative, Palliation, Cancer, Care, SPC, Caregivers, Home Care Services, Hospital-Based, Psychological, From Oncological Treatment to Palliative Care at Home, Place of death
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition programOther
Accelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 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. |
| Intervention Group | Other | Accelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients Receives: Other: Transition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Place of care and death
To investigate whether the transition process and SPC at home in patients with incurable cancer results in more patients in accordance with his/her own request obtains treatment, care, and death in their own homes.
Measured: Up to 4.5 years
Secondary outcomes (19)
HRQL
Whether there is a difference between intervention - and the control groups in change from baseline to the weighted average of 2, 4 and 8-week follow up ("mixed-effect" regressions model) for symptoms / problems and quality of life measured with EORTC QLQ-C30 and The Edmonton Symptom Assessment System (ESAS) and for anxiety and depression measured by HADS. In addition, patients will be asked to prioritize their symptoms after how annoying they are according to a list of symptoms / side effects.
Measured: Up to 4.5 years
Use of medicine
Whether there is a difference between the intervention and control groups in the change from baseline to the weighted average of 2, 4 and 8-week follow up ("mixed-effect" regressions model) in medication use.
Measured: Up to 4.5 years
Survival time
Whether there are differences in the proportion surviving in the two groups and whether the survival time is different between the 2 groups.
Measured: Up to 4.5 years
Healthcare services and informal care
Whether there are differences in resource use (healthcare services and informal care) between the two groups.
Measured: Up to 4.5 years
Cooperation and quality of the process
Whether there is a difference between the professionals' assessments of cooperation and quality of the process in the intervention and control groups.
Measured: Up to 4.5 years
Anxiety and depression
Whether patients in the intervention group will have less anxiety and depression than patients in the control group.
Measured: Up to 4.5 years
Caregiver: anxiety and depression
Whether there is a difference between caregivers in the intervention and control groups in the change from baseline to 2, 4 and 8-week follow up in anxiety and depression (as assessed by the SCL-92), and whether there is a difference in anxiety and depression between caregivers in the intervention and control groups at follow-up 2 weeks, 2, 7, 13, and 19 months after bereavement.
Measured: Up to 4.5 years
Caregiver: prolonged grief
Whether caregivers in the intervention group will less frequently exhibit prolonged grief (as measured by the PG-13 questionnaire) and have fewer symptoms of prolonged grief than caregivers in the control group at follow-up assessments at 2 weeks, 2, 7, 13, and 19 months after bereavement.
Measured: Up to 4.5 years
Dyadic coping
Whether there is a difference between patient and caregiver dyads in the intervention and control groups in the change from baseline to 2, 4 and 8-week follow up in dyadic coping (as assessed by subscales of the Dyadic Coping Inventory (DCI)).
Measured: Up to 4.5 years
Preference for place of treatment and care
Whether there will be a difference in the preference for place of treatment and care between patients and caregivers in the intervention and control groups, as assessed at baseline and the 2, 4, and 8 week follow-up.
Measured: Up to 4.5 years
Caregiver: HRQoL
Whether there is a difference between caregivers in the intervention and control group in the change from baseline to 2, 4 and 8-week follow up in health related quality of life, as measured by the SF-36 (incl. subscales) , and between bereaved caregivers in the intervention and control group at 2 weeks, 2, 7, 13, and 19 months after bereavement.
Measured: Up to 4.5 years
Caregiver: Use of health services
Whether there is a difference in use of health care services between caregivers in the intervention and control group, as obtained from registers.
Measured: Up to 4.5 years
Caregiver burden
Whether there is a difference between caregivers in the intervention and control groups in the change from baseline to 2, 4 and 8-week follow up in caregiver burden, as measured by the Zarit Burden Interview (ZBI).
Measured: Up to 4.5 years
Caregiver: telomere degradation
Whether telomere degradation will be lower and telomerase activity higher between baseline and 2 months after bereavement among caregivers in the intervention group than among caregivers in the control group.
Measured: Up to 4.5 years
Caregiver: The psychological intervention
Within the intervention group, it will be examined which elements of the psychological intervention were experienced as meaningful / efficacious by the bereaved caregivers after the intervention.
Measured: Up to 4.5 years
Caregiver Grief
Whether there will be a difference in bereaved caregivers' grief in the intervention and control group, as measured by the Inventory of Daily Widowed Life(IDWL) (and its subscales) at 2 weeks, 2, 7, 13, and 19 months after bereavement.
Measured: Up to 4.5 years
Caregiver health behavior
Whether there is a difference between bereaved caregivers' health behavior in the intervention and control group, as measured by items on alcohol consumption, smoking, meals, and physical activity, and the PSQI at 2 weeks, 2, 7, 13, and 19 months after bereavement.
Measured: Up to 4.5 years
Hospital admissions
Whether there is a difference in cause, number, type, length and outcome of admissions between the groups.
Measured: Up to 4.5 years
Non-participation
To investigate differences between participants and non-participants on demographic and clinical characteristics, and self-reported symptom burden, as well as reasons for non-participation in the DOMUS study and their relation to non-participant-characteristics
Measured: up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2017
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Incurable CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, TRYG Foundation, The Danish Institute for Health Services Research, Copenhagen, Denmark, University of Copenhagen, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
- Responsible party
- Principal investigator, Per Sjogren, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Per Sjøgren, Proff., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885637
- Sponsor's protocol ID
- H-4-2013-016
- Other IDs
- 2007--58--0015
- Acronym
- DOMUS
- Status last verified
- May 2022
- First submitted
- 17 Jun 2013
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Halling CMB, Wolf RT, Sjogren P, Von Der Maase H, Timm H, Johansen C, Kjellberg J. Cost-effectiveness analysis of systematic fast-track transition from oncological treatment to specialised palliative care at home for patients and their caregivers: the DOMUS trial. BMC Palliat Care. 2020 Sep 15;19(1):142. doi: 10.1186/s12904-020-00645-7.
PubMed 32933489Benthien K, Diasso P, von Heymann A, Nordly M, Kurita G, Timm H, Johansen C, Kjellberg J, von der Maase H, Sjogren P. Oncology to specialised palliative home care systematic transition: the Domus randomised trial. BMJ Support Palliat Care. 2020 Sep;10(3):350-357. doi: 10.1136/bmjspcare-2020-002325. Epub 2020 Jul 17.
PubMed 32680894von Heymann-Horan A, Bidstrup P, Guldin MB, Sjogren P, Andersen EAW, von der Maase H, Kjellberg J, Timm H, Johansen C. Effect of home-based specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression: a randomised controlled trial. Br J Cancer. 2018 Nov;119(11):1307-1315. doi: 10.1038/s41416-018-0193-8. Epub 2018 Nov 14.
PubMed 30425351Nordly M, Skov Benthien K, Vadstrup ES, Kurita GP, von Heymann-Horan AB, von der Maase H, Johansen C, Timm H, Kjellberg J, Sjogren P. Systematic fast-track transition from oncological treatment to dyadic specialized palliative home care: DOMUS - a randomized clinical trial. Palliat Med. 2019 Feb;33(2):135-149. doi: 10.1177/0269216318811269. Epub 2018 Nov 12. No abstract available.
PubMed 30415608von Heymann-Horan A, Bidstrup PE, Johansen C, Rottmann N, Andersen EAW, Sjogren P, von der Maase H, Timm H, Kjellberg J, Guldin MB. Dyadic coping in specialized palliative care intervention for patients with advanced cancer and their caregivers: Effects and mediation in a randomized controlled trial. Psychooncology. 2019 Feb;28(2):264-270. doi: 10.1002/pon.4932. Epub 2018 Nov 15.
PubMed 30353600Skov Benthien K, Nordly M, von Heymann-Horan A, Rosengaard Holmenlund K, Timm H, Kurita GP, Johansen C, Kjellberg J, von der Maase H, Sjogren P. Causes of Hospital Admissions in Domus: A Randomized Controlled Trial of Specialized Palliative Cancer Care at Home. J Pain Symptom Manage. 2018 Mar;55(3):728-736. doi: 10.1016/j.jpainsymman.2017.10.007. Epub 2017 Oct 19.
PubMed 29056562Benthien KS, Nordly M, Videbaek K, Kurita GP, von der Maase H, Timm H, Simonsen MK, Johansen C, Sjogren P. Classification of a palliative care population in a comprehensive cancer centre. Support Care Cancer. 2016 Apr;24(4):1865-73. doi: 10.1007/s00520-015-2979-z. Epub 2015 Oct 13.
PubMed 26463644Nordly M, Benthien KS, Von Der Maase H, Johansen C, Kruse M, Timm H, Vadstrup ES, Kurita GP, von Heymann-Horan AB, Sjogren P. The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home. BMC Palliat Care. 2014 Sep 9;13:44. doi: 10.1186/1472-684X-13-44. eCollection 2014.
PubMed 25242890
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
- ClinicalTrials.gov ID
- NCT01885637
- Acronym / sponsor ID
- DOMUS / H-4-2013-016
- Conditions
- Incurable Cancer
- Keywords
- Palliative, Palliation, Cancer, Care, SPC, Caregivers, Home Care Services, Hospital-Based, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society, TRYG Foundation, The Danish Institute for Health Services Research, Copenhagen, Denmark, University of Copenhagen, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
- Study start
- Jun 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 25 Jun 2013 (estimated)
- 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.
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 patient's 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 he/she 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 (DCI)and 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 patient's 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 patient's 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-92),Pittsburgh 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 Grief(PG-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:
- 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.
- At day one or two after randomization the research nurse, the patient and informal caregiver discuss the patient's wishes for specialised palliative care in their own home and how these can be reconciled with the caregiver's wishes. The patient and caregiver's perceptions of challenges and concerns related to home care are explored and addressed.
- Immediately after the planning meeting the conditions in the home are optimized, if needed.
- 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 patient's 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.
- 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 patient's 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 patient's 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 (i.e. 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 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. |
| Intervention Group | Other | Other: Transition programAccelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (at least 18 year old) cancer patients connected to the Department of Oncology, Copenhagen University Hospital
- Patients who want to spend as much time as possible in their own homes supported by an SPT
- Patients with incurable cancer
- Patients with no or limited antineoplastic treatment options or patients who resign antineoplastic treatment
- Patients living in the Capital Region
Key exclusion criteria (5 listed)
- Patients who have already been referred to an SPT
- Hospitalized patients who are not judged capable of being discharged home
- Patients who are admitted to other hospitals
- Patients who do not speak Danish well enough to answer the questionnaires
- Patients who are considered incapable of cooperating in the trial
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 |
|---|---|---|
| Transition programAccelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients | Other | Intervention Group |
Primary outcome
Place of care and death
Time frame: Up to 4.5 years
To investigate whether the transition process and SPC at home in patients with incurable cancer results in more patients in accordance with his/her own request obtains treatment, care, and death in their own homes.
19 secondary outcomes
HRQL
Time frame: Up to 4.5 years
Use of medicine
Time frame: Up to 4.5 years
Survival time
Time frame: Up to 4.5 years
Healthcare services and informal care
Time frame: Up to 4.5 years
Cooperation and quality of the process
Time frame: Up to 4.5 years
Anxiety and depression
Time frame: Up to 4.5 years
Caregiver: anxiety and depression
Time frame: Up to 4.5 years
Caregiver: prolonged grief
Time frame: Up to 4.5 years
Dyadic coping
Time frame: Up to 4.5 years
Preference for place of treatment and care
Time frame: Up to 4.5 years
Caregiver: HRQoL
Time frame: Up to 4.5 years
Caregiver: Use of health services
Time frame: Up to 4.5 years
Caregiver burden
Time frame: Up to 4.5 years
Caregiver: telomere degradation
Time frame: Up to 4.5 years
Caregiver: The psychological intervention
Time frame: Up to 4.5 years
Caregiver Grief
Time frame: Up to 4.5 years
Caregiver health behavior
Time frame: Up to 4.5 years
Hospital admissions
Time frame: Up to 4.5 years
Non-participation
Time frame: up to 4.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Derived from this study: PubMed 32933489Halling CMB, Wolf RT, Sjogren P, Von Der Maase H, Timm H, Johansen C, Kjellberg J. Cost-effectiveness analysis of systematic fast-track transition from oncological treatment to specialised palliative care at home for patients and their caregivers: the DOMUS trial. BMC Palliat Care. 2020 Sep 15;19(1):142. doi: 10.1186/s12904-020-00645-7.
- Derived from this study: PubMed 32680894Benthien K, Diasso P, von Heymann A, Nordly M, Kurita G, Timm H, Johansen C, Kjellberg J, von der Maase H, Sjogren P. Oncology to specialised palliative home care systematic transition: the Domus randomised trial. BMJ Support Palliat Care. 2020 Sep;10(3):350-357. doi: 10.1136/bmjspcare-2020-002325. Epub 2020 Jul 17.
- Derived from this study: PubMed 30425351von Heymann-Horan A, Bidstrup P, Guldin MB, Sjogren P, Andersen EAW, von der Maase H, Kjellberg J, Timm H, Johansen C. Effect of home-based specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression: a randomised controlled trial. Br J Cancer. 2018 Nov;119(11):1307-1315. doi: 10.1038/s41416-018-0193-8. Epub 2018 Nov 14.
- Derived from this study: PubMed 30415608Nordly M, Skov Benthien K, Vadstrup ES, Kurita GP, von Heymann-Horan AB, von der Maase H, Johansen C, Timm H, Kjellberg J, Sjogren P. Systematic fast-track transition from oncological treatment to dyadic specialized palliative home care: DOMUS - a randomized clinical trial. Palliat Med. 2019 Feb;33(2):135-149. doi: 10.1177/0269216318811269. Epub 2018 Nov 12. No abstract available.
- Derived from this study: PubMed 30353600von Heymann-Horan A, Bidstrup PE, Johansen C, Rottmann N, Andersen EAW, Sjogren P, von der Maase H, Timm H, Kjellberg J, Guldin MB. Dyadic coping in specialized palliative care intervention for patients with advanced cancer and their caregivers: Effects and mediation in a randomized controlled trial. Psychooncology. 2019 Feb;28(2):264-270. doi: 10.1002/pon.4932. Epub 2018 Nov 15.
- Derived from this study: PubMed 29056562Skov Benthien K, Nordly M, von Heymann-Horan A, Rosengaard Holmenlund K, Timm H, Kurita GP, Johansen C, Kjellberg J, von der Maase H, Sjogren P. Causes of Hospital Admissions in Domus: A Randomized Controlled Trial of Specialized Palliative Cancer Care at Home. J Pain Symptom Manage. 2018 Mar;55(3):728-736. doi: 10.1016/j.jpainsymman.2017.10.007. Epub 2017 Oct 19.
- Derived from this study: PubMed 26463644Benthien KS, Nordly M, Videbaek K, Kurita GP, von der Maase H, Timm H, Simonsen MK, Johansen C, Sjogren P. Classification of a palliative care population in a comprehensive cancer centre. Support Care Cancer. 2016 Apr;24(4):1865-73. doi: 10.1007/s00520-015-2979-z. Epub 2015 Oct 13.
- Derived from this study: PubMed 25242890Nordly M, Benthien KS, Von Der Maase H, Johansen C, Kruse M, Timm H, Vadstrup ES, Kurita GP, von Heymann-Horan AB, Sjogren P. The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home. BMC Palliat Care. 2014 Sep 9;13:44. doi: 10.1186/1472-684X-13-44. eCollection 2014.
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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. This study is not recruiting at the moment.
Per Sjøgren, Proff. principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition program in people with Incurable Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 May 2022. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Place of care and death (time frame: Up to 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885637, which also lists 8 linked publications.
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 3 May 2022.