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

NCT01885637 | Completed

• 2 other identifiers: H-4-2013-0162007--58--0015
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Incurable Cancer

Keywords

Palliative; Palliation; Cancer; Care; SPC; Caregivers; Home Care Services, Hospital-Based; Psychological; From Oncological Treatment to Palliative Care at Home; Place of death

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• HRQL

  Up to 4.5 years

• Use of medicine

  Up to 4.5 years

• Survival time

  Up to 4.5 years

• Healthcare services and informal care

  Up to 4.5 years

• Cooperation and quality of the process

  Up to 4.5 years

Study Arms (2)

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

Other: Transition program

Interventions

Transition program OTHER

Accelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator
• TRYG Foundation: collaborator
• The Danish Institute for Health Services Research, Copenhagen, Denmark: collaborator
• University of Copenhagen: collaborator
• Danish Knowledge Centre for Palliative Care, Copenhagen, Denmark: collaborator

Study Sites (1)

Depatment of Oncology, Rigshospitalet

Copenhagen Ø, Denmark

Location

Related Publications (8)

• 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.

  PMID: 32933489 DERIVED

• Benthien 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.

  PMID: 32680894 DERIVED

• von 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.

  PMID: 30425351 DERIVED

• Nordly 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.

  PMID: 30415608 DERIVED

• von 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.

  PMID: 30353600 DERIVED

• Skov 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.

  PMID: 29056562 DERIVED

• Benthien 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.

  PMID: 26463644 DERIVED

• Nordly 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.

  PMID: 25242890 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Per Sjøgren, Proff.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D., Dr. Med. Sci

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: June 1, 2019
• Last Updated: May 3, 2022

Record last verified: 2022-05

Locations

DK (1)