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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

Tracking Information
First Submitted Date  ICMJE June 17, 2013
First Posted Date  ICMJE June 25, 2013
Last Update Posted Date May 3, 2022
Study Start Date  ICMJE June 2013
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
Place of 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Ambulatory vs. hospitalized patients [ Time Frame: Up to 4.5 years ]
    Whether there is a difference between groups of ambulatory and hospitalized patients at baseline, as well as in the further process.
  • 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.
  • 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.
  • 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.
  • 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)).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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 activty, and the PSQI at 2 weeks, 2, 7, 13, and 19 months after bereavement.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DOMUS: A Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
Official Title  ICMJE DOMUS: A Randomized Controlled Clinical Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home
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.
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:

  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 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.
  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 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.
  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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Incurable Cancer
Intervention  ICMJE Other: Transition program
Accelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients
Study Arms  ICMJE
  • 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
    Intervention: Other: Transition program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2013)
340
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01885637
Other Study ID Numbers  ICMJE H-4-2013-016
2007--58--0015 ( Other Identifier: The Danish Data Protection Agency )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Per Sjogren, Rigshospitalet, Denmark
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rigshospitalet, Denmark
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Per Sjøgren, Proff. Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP