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DOMUS: A Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home (DOMUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885637
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : May 3, 2022
Sponsor:
Collaborators:
Danish Cancer Society
TRYG Foundation
The Danish Institute for Health Services Research, Copenhagen, Denmark
Department of Psychology, Copenhagen University, Denmark
Danish Knowledge Centre for Palliative Care, Copenhagen, Denmark
Information provided by (Responsible Party):
Per Sjogren, Rigshospitalet, Denmark

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 patient's death.

Condition or disease Intervention/treatment Phase
Incurable Cancer Other: Transition program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
Study Start Date : June 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
No Intervention: Control group
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
Accelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients
Other: Transition program
Accelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. HRQL [ Time Frame: Up to 4.5 years ]
    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.

  2. Use of medicine [ Time Frame: Up to 4.5 years ]
    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.

  3. Survival time [ Time Frame: Up to 4.5 years ]
    Whether there are differences in the proportion surviving in the two groups and whether the survival time is different between the 2 groups.

  4. Healthcare services and informal care [ Time Frame: Up to 4.5 years ]
    Whether there are differences in resource use (healthcare services and informal care) between the two groups.

  5. Cooperation and quality of the process [ Time Frame: Up to 4.5 years ]
    Whether there is a difference between the professionals' assessments of cooperation and quality of the process in the intervention and control groups.

  6. Anxiety and depression [ Time Frame: Up to 4.5 years ]
    Whether patients in the intervention group will have less anxiety and depression than patients in the control group.

  7. Caregiver: anxiety and depression [ Time Frame: Up to 4.5 years ]
    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.

  8. Caregiver: prolonged grief [ Time Frame: Up to 4.5 years ]
    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.

  9. Dyadic coping [ Time Frame: Up to 4.5 years ]
    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)).

  10. Preference for place of treatment and care [ Time Frame: Up to 4.5 years ]
    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.

  11. Caregiver: HRQoL [ Time Frame: Up to 4.5 years ]
    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.

  12. Caregiver: Use of health services [ Time Frame: Up to 4.5 years ]
    Whether there is a difference in use of health care services between caregivers in the intervention and control group, as obtained from registers.

  13. Caregiver burden [ Time Frame: Up to 4.5 years ]
    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).

  14. Caregiver: telomere degradation [ Time Frame: Up to 4.5 years ]
    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.

  15. Caregiver: The psychological intervention [ Time Frame: Up to 4.5 years ]
    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.

  16. Caregiver Grief [ Time Frame: Up to 4.5 years ]
    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.

  17. Caregiver health behavior [ Time Frame: Up to 4.5 years ]
    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.

  18. Hospital admissions [ Time Frame: Up to 4.5 years ]
    Whether there is a difference in cause, number, type, length and outcome of admissions between the groups.

  19. Non-participation [ Time Frame: up to 4.5 years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885637


Locations
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Denmark
Depatment of Oncology, Rigshospitalet
Copenhagen Ø, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Cancer Society
TRYG Foundation
The Danish Institute for Health Services Research, Copenhagen, Denmark
Department of Psychology, Copenhagen University, Denmark
Danish Knowledge Centre for Palliative Care, Copenhagen, Denmark
Investigators
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Principal Investigator: Per Sjøgren, Proff. Rigshospitalet, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Per Sjogren, Professor, M.D., Dr. Med. Sci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01885637    
Other Study ID Numbers: H-4-2013-016
2007--58--0015 ( Other Identifier: The Danish Data Protection Agency )
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: May 2022
Keywords provided by Per Sjogren, Rigshospitalet, Denmark:
Palliative
Palliation
Cancer
Care
SPC
Caregivers
Home Care Services, Hospital-Based
Psychological
From Oncological Treatment to Palliative Care at Home
Place of death