Incurable Cancer Clinical Trial
— DOMUSOfficial title:
DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
| Verified date | May 2022 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 340 |
| Est. completion date | June 2019 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Depatment of Oncology, Rigshospitalet | Copenhagen Ø |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark | Danish Cancer Society, Danish Knowledge Centre for Palliative Care, Copenhagen, Denmark, Department of Psychology, Copenhagen University, Denmark, The Danish Institute for Health Services Research, Copenhagen, Denmark, TRYG Foundation |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | Healthcare services and informal care | Whether there are differences in resource use (healthcare services and informal care) between the two groups. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | Anxiety and depression | Whether patients in the intervention group will have less anxiety and depression than patients in the control group. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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)). | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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). | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | 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. | Up to 4.5 years | |
| Secondary | Hospital admissions | Whether there is a difference in cause, number, type, length and outcome of admissions between the groups. | Up to 4.5 years | |
| Secondary | 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 | up to 4.5 years |