Trial Information

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

The trial is a controlled, randomized 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 must be randomized within 3 days after their consent and 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 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 acute worsening of the condition resulting in readmissions of the patients in
both groups, the ESAS is completed by the patient in the hospital. If there are other causes
for readmissions, these should be indicated under "other problem" at the bottom of the ESAS.

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
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 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 a planning meeting is held with a research nurse,
where the patient and informal caregiver discuss the patient's wishes for treatment and
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 a home visit is conducted to optimize the
conditions in the home, if such actions have not already been taken.

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. The SPT in collaboration with the GP and district nursing is now responsible for
the distribution of tasks related to treatment and care.

5. Patients and caregivers (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 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 lasts until death or six months after the last patient has entered the study.
Patients in the intervention group can then choose to proceed with the SPT. 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.

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 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.