Symptoms and General Pathology

All Conditions

Nervous System Diseases

Recurrence

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Morphine

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Hospitalized participants asked to complete a number of surveys at baseline. Participants then receive one single dose of intravenous opioid rescue for their first episode of breakthrough pain, and then receive up to 4 doses of FSS for subsequent episodes of breakthrough pain. Initial FSS starting dose is proportional to the patient's morphine equivalent daily dose (MEDD). Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose. At the time of discharge, if FSS was helpful in controlling participant's pain, they are then able to continue with FSS use for 1 month. Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.

Stage 1: First Pain Episode - Single dose of breakthrough opioid given from existing PCA pump equivalent to 10% of their MEDD.

Second Pain Episode - Single dose of FSS equivalent to 16-32% of MEDD. If not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum.

Third Pain Episode (at least 4 hours after second episode) - Participant required 2 breakthrough FSS doses for the last episode of breakthrough pain, or if the effective dose has not been identified, he/she will double the last administered dose. If breakthrough pain not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum).

Stage 2: If FSS successful in hospital, upon discharge, FSS used as first choice of pain medication instead of oral pain medication for pain for up to 4 weeks.

Fentanyl Sublingual Spray (FSS)

Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. After Day 28, questionnaire completed over the phone about participant's opinion of research study.

Questionnaires

Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose.

Mental Ability Tests

Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.

Study Diary

Suresh Reddy, MD

The goal of this clinical research study is to learn if an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.

Study Visits and Study Drug Administration:

This study has 2 stages. Stage 1 will be completed while you are in the inpatient unit of the hospital and Stage 2 will be completed after you are discharged from the hospital.

Stage 1:

While you are in the hospital, if you have a pain episode, the research nurse will give you a single dose of your current pain medication from your existing infusion pump. You will then be asked to rate your current level of pain . You will also be asked if you are having any side effects at 15 minutes and at 30 minutes after the dose has been administered. You will also complete the 4 tests of mental abilities after about 30 minutes.

If after 1-4 hours you have another episode of pain, you will be given a single dose of FSS. You will spray FSS under your tongue and hold it there for about 30-60 seconds before swallowing. You will be asked about your current level of pain at about 15 minutes and 30 minutes after your dose of FSS. You will also complete the 4 tests of mental abilities after about 30 minutes. If you do not feel any pain relief after 30 minutes, you will spray FSS 1 more time under your tongue and you will repeat the pain and mental ability tests.

If you still do not feel any pain relief after about 4 hours from the last dose of FSS, you will spray a double dose of FSS under your tongue up to 2 times and your pain level and mental abilities will be tested at 15 and 30 minutes after each dose.

You may receive FSS up to 4 times total while you are in the hospital.

After your last dose of FSS, you will complete a questionnaire about how your symptoms are after receiving FSS. This should take about 2 minutes to complete.

End of Stage 1:

If FSS was able to help you control your pain, you will stop taking FSS and go back to receiving your regular pain medication for the rest of your hospital stay. When you are discharged from the hospital, you will continue on to Stage 2 of the study (described below) to receive FSS for up to 4 weeks at home. Before you are sent home, you will also be prescribed pain medication to take in addition to the FSS, if needed. Your doctor will explain how to take this medication before you are discharged.

If FSS was not able to help control your pain, your participation in this study will end and you will continue to be treated with standard pain medications.

Stage 2:

If you are taking part in Stage 2, you will use FSS as your first choice of pain medication instead of oral pain medication for pain for up to 4 weeks. At any time that you have a pain episode, you will spray FSS under your tongue.

You will always have the choice of using the pain medication your doctor prescribed to you as a backup every 2 hours as needed for pain. However, it is very important that you do NOT use the oral pain medications at the same time as FSS. If you still have pain after taking FSS, you must wait at least 2 hours before using your pain medications. After 2 more hours if you have another episode of pain, you may use another dose of FSS for pain relief.

Do not take more than 4 doses of FSS each day.

You will be given a patient diary to write down each day your pain level, how many times you used FSS, and any side effects you may have. You will be called at least 2 times each week by a member of the study staff to discuss your diary and to answer any questions you may have. The study staff will also ask you which pain medication you are using besides FSS, how easy you think it is to use FSS, how effective you think FSS is, and how satisfied you are with your current pain medications. Each phone call should last about 10 minutes.

After Day 28, you will complete a questionnaire over the phone about your opinion of this research study. This should take about 5 minutes to complete.

Length of Study:

Your active participation in this study is over after you complete the last questionnaire. You will be taken off study if intolerable side effects occur or if you are unable to follow study directions.

Follow-Up:

About 30 days after your study visit, you will be called by the study staff and asked how you are feeling and about any side effects you may be having. This call should last about 10 minutes.

This is an investigational study. FSS is FDA approved and commercially available for the treatment of pain in cancer patients. It is considered investigational to use the dose of FSS used in this study and to use FSS both in inpatient and outpatient settings.

About 30 participants will be enrolled in this study. All will take part at MD Anderson.

Sublingual Fentanyl for the Management of Breakthrough Pain

A Preliminary Study of Sublingual Fentanyl for the Management of Breakthrough Pain Analgesia in Patients With Advanced Cancer

To determine the effective dose of Fentanyl sublingual spray in the management of breakthrough pain (4 episodes) in hospitalized patients with advanced cancer receiving continuous opioid infusion in which the first starting dose would be proportional to the patients Morphine Equivalent Daily Dose. It will use Alberta Breakthrough Pain assessment tool with 15 questions.

To estimate the differences in the pain response between intravenous opioid breakthrough and fentanyl sublingual spray at effective dose. Pain will be assessed in a 0-10 numeric rating scale that assesses pain intensity now, where 0=no pain at all, and 10=worst possible.

To determine the safety, tolerability, pattern of use and efficacy of Fentanyl sublingual spray in patients with advanced cancer

INSYS Therapeutics Inc

M.D. Anderson Cancer Center

Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Married

Separated/Divorced

Marital status

Some high School

Some College

Completed College

Did not answer

Education

Colon

Gastric

Melanoma

Cholangiocarcinoma

Lymphoma

Cancer Type

Suresh K. Reddy, MD/Professor, Palliative Care Med

Data was not collected due to low accrual and early termination.

Effective Dose of Fentanyl Sublingual Spray (FSS)

Difference Between Intravenous Opioid and Fentanyl Sublingual Spray

Safety, Tolerability, Pattern of Use and Efficacy

Overall Study

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Quality of Life

Barry JA Laird, MBCHB MD

Rebekah Patton

People with incurable cancer often have complex individual needs, however there are several common themes encountered when considering this group.

As cancer progresses there are series of interactions between the tumour and the patient, producing both local and systemic effects. This altered state of illness can have multiple ill effects including weight loss, fatigue, increased symptom burden and reduction in physical function which all contribute to a reduced quality of life.

These areas are often studied in isolation, giving an incomplete picture. A detailed, holistic characterisation of this group of people does not exist.

A robust characterisation of people with incurable cancer will allow identification and prioritisation of future research and has the potential to inform new therapeutics and provide justification for treatments.

This study aims to collect information about symptoms and quality of life, weight loss and body composition, physical activity and the body's immune response to cancer.

Participants with incurable cancer will be recruited to the study from oncology and palliative medicine services in the UK. Participants will answer questionnaires about quality of life and symptoms, have bloods taken for inflammatory marker and cytokine analysis and have their body composition measured by a variety of methods.

Blood samples - samples sent for routine inflammatory markers, plasma retained for analysis of cytokine levels and stored in a biobank for use in future ethically approved studies including potential genetic DNA analysis.

Archival tissue specimens (including fresh frozen and/or formalin fixed paraffin embedded biopsy/surgical specimens) that are no longer required by the local pathologist for diagnostic purposes, or are stored as part of ethically approved tissue collection/research studies, may be requested from patients in the course of establishing the biobank for further analysis in future studies

Routine Evaluation of People Living With Cancer

Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms

Correlation of serum levels of inflammatory cytokines with clinical parameters including skeletal muscle mass, symptom based scores and physical activity as measured by actigraphy.

NHS Lothian

University of Edinburgh

Patients over 60 years old with advanced, incurable cancer.

This care planning framework aims to implement existing tools in geriatric medicine, palliative medicine, and medical oncology to aid in cancer care planning for older adults with newly diagnosed incurable advanced cancer and to test the delivery of goal-concordant care. This patient-centered intervention is the ABC123 care planning framework in parallel with usual care that includes a physical function assessment, chemotherapy toxicity estimate calculation, and a guided goals of care discussion.

ABC123 Framework

Elizabeth Kessler

Pilot study assessing the feasibility and acceptability of the ABC123 framework, as well as goal concordance between patient and clinician stated goals. Patients \>60 years old with recently diagnosed advanced, incurable cancer in for a first consultation at a participating medical oncology clinic. The team will pilot test the ABC123 framework delivery by an advanced practice provider working with a medical oncologist to inform the overall care planning process. This framework will routinely incorporate and implement existing resources from these 3 transdisciplinary tenets (geriatric, oncology, and palliative medicine) into initial care planning in a patient-centered manner. The team will follow patients from initial care planning to 6 months post-intervention and assess additional stakeholder feedback on barriers and facilitators to implementation.

The ABC123 care planning framework is aimed at increasing care alignment delivered to older patients with advanced cancer by combining existing tools that represent the principles of geriatrics, oncology, and palliative care. In this pilot study, our primary goals are to assess the feasibility and acceptability of the ABC123 care planning framework and evaluate the framework's impact on the provision of care that aligns with the goals and values of patients. Participants will participate in a series of visits and follow-ups meant to implement and evaluate the ABC123 care planning framework that will take place over the course of six months. The first two visits will consist of 1) a short physical performance battery (SPPB) and estimation of potential for grade 3 chemotherapy toxicity using the Cancer and Aging Research Group chemotherapy toxicity calculator and 2) guided goals of care discussion with an Advanced Practice Provider based on the findings from visit 1. During 1, 3, and 6-month follow-up sessions, participants will complete a survey consisting of several commonly used questionnaires and an interview about experiences and goals. Care providers and institutional stakeholders will also be interviewed at 1, 2, and 3 years after initial implementation to understand experiences and assess the feasibility if the ABC123 framework.

Care Planning Framework in Advanced Cancer (ABC123)

Feasibility and Acceptability of the ABC123 Framework for Advanced Cancer Care

Recruitment (proportion of those approached who actually enroll)

Retention number of those completing both clinic sessions

Retention number of those completing both sessions, and follow up

American Cancer Society, Inc.

University of Colorado, Denver

Anxiety Disorders

Depressive Disorder

Depression

Psychotropic Drugs

Dignity Therapy is a brief psychotherapeutic intervention consisting of:

1. a tape-recorded session with the patient using the DT question protocol
2. Transcription of the interview, which is then edited
3. A session where the edited transcript is returned to the patient who can give it to family members or friends.

If needed, one or more sessions are added. Dt allows the patient to give voice to the matters of importance concerning himself and his loved ones. Its purpose is to enhance sense of meaning, purpose and worth. It also gives the opportunity to leave something behind to be remembered by.

Dignity Therapy

Mogens Groenvold, MD PhD DSci

The purpose of the study is to investigate whether Danish patients with incurable cancer have a need of, interest in and benefit from Dignity Therapy.

Research in palliative care has primarily focused on physical and psychological symptoms. Research in other psychosocial and existential problems has been sparse. Loss of dignity as a consequence of serious illness may be an important cause of suffering. The research team of the Canadian psychiatrist and professor, Harvey Chochinov has investigated the concept of dignity and developed the psychosocial intervention 'Dignity Therapy' (DT). The preliminary research results were promising.

Research questions: Do Danish cancer patients have a need of, interest in, and benefit from DT? Methods: DT consists of an interview revolving around the patient's life, values, and accomplishments and is also an opportunity to leave messages and words of hope and compassion for friends and family. The interview is audio taped, transcribed, and edited together with the patient, and made into a tangible document, which the patient can give to his/her relatives. The project consists of three parts: (1) a cross-sectional investigation of the prevalence of loss of dignity and related symptoms/problems among at least 200 incurable cancer patients. (2) A feasibility study, testing the intervention in terms of relevance and the need of any modifications in relation to Danish patients. (3) An evaluation study testing the effect of and satisfaction with DT.

At least 80 patients are planned for the feasibility and evaluation studies. Questionnaires are used for detection of loss of dignity and as measures of effect. These will be administered before the intervention and, along with a semi-structured evaluation questionnaire, right after the intervention, when the document is received and again approximately two weeks later.

The duration of the intervention (DT) varies markedly between patients. In some cases the process (interview, transcription, editing of document, and the final meeting where the document is given back to the patient) is completed urgently in a few days, whereas in other cases, the patient prefers a slower pace, and may want to sub-divide the interview into two or more parts. Also, when presented with the document, some patients want to have something changed or they want add material. This variation is seen as intentional, as it illustrates that the process is tailored to the patient's wishes.

As stated, the effect of the DT intervention is evaluated at completion of the intervention, i.e. when the final document is given back to the patient, and about two weeks later. Due to process described above, the time from the first measurement (before intervention) to the second measurement (which takes places at completion of the intervention) therefore varies considerably (median 36 days after baseline, range 7-121 days).

Perspective: If Danish patients have a need of, an interest in and benefit from DT, it can be offered to Danish patients admitted to palliative care.

Implementation and Evaluation of Dignity Therapy in Denmark

Measured with the Structured Interview for Symptoms and Concerns (SISC)

Measured on the Hospital anxiety and depression scale

Measured on the Hospital Anxiety and Depression scale

Measured on the Patient Dignity Inventory

Measured with the Structured Interview for Symptoms and Concerns

Measured on the Palliative Performance Scale v2

Measured on the Structured Interview for Symptoms and Concerns

Bispebjerg Hospital

MD, PhD, D.M.Sci.

Death

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.

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

Transition program

Per Sjøgren, Proff.

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.

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.

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

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

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.

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.

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.

Whether there are differences in the proportion surviving in the two groups and whether the survival time is different between the 2 groups.

Whether there are differences in resource use (healthcare services and informal care) between the two groups.

Whether there is a difference between the professionals' assessments of cooperation and quality of the process in the intervention and control groups.

Whether patients in the intervention group will have less anxiety and depression than patients in the control group.

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.

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.

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)).

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.

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.

Whether there is a difference in use of health care services between caregivers in the intervention and control group, as obtained from registers.

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).

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.

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.

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.

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.

Whether there is a difference in cause, number, type, length and outcome of admissions between the groups.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sublingual Fentanyl for the Management of Breakthrough Pain	NCT02514252	Advanced Cancer...	Fentanyl Sublin... Questionnaires Mental Ability ... Study Diary	18 Years -	M.D. Anderson Cancer Center
Routine Evaluation of People Living With Cancer	NCT04406662	Cachexia; Cance... Advanced Cancer Quality of Life		18 Years -	University of Edinburgh
Care Planning Framework in Advanced Cancer (ABC123)	NCT05408507	Advanced Cancer	ABC123 Framewor...	60 Years -	University of Colorado, Denver
Implementation and Evaluation of Dignity Therapy in Denmark	NCT01507571	Cancer	Dignity Therapy	18 Years -	Bispebjerg Hospital
DOMUS: A Trial of Accelerated Transition From Oncological Treatment to Continuing Palliative Care at Home	NCT01885637	Incurable Cance...	Transition prog...	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for incurable cancer