Multiple MyelomaACTNCT05444348
Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)
A study testing Advance consultation concerning your life and treatment (ACT ) in people with Multiple Myeloma and Myelodysplastic Syndromes, run by Christoffer Johansen at 7 sites in Denmark.
Trial summary
Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma
- What is being tested?
- Advance consultation concerning your life and treatment (ACT )
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 7 sitesDenmark
- Study dates
- 1 Aug 2022to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must:
- Be at least 18 years of age
- Have a diagnosis of one of the following:
- High-risk myelodysplastic syndrome (MDS) or MDS with overlap of myeloproliferative neoplasms (high-risk MDS/MPN),
- Acute myeloid leukemia(AML): Age≥80 or in palliative treatment or relapse
- Lymphoma: Age≥80 or relapse or refractory or palliative treatment
Show all 20Show fewer
- Multiple myeloma(MM): Age≥80 or relapsed or refractory
- Have limited treatment options. Provide informed consent. Have sufficient Danish skills to complete intervention sessions and data collection
- An informal caregiver is identified by the patient as the primary provider of informal physical, practical or emotional support and must:
- Be at least 18 years of age
- Be able to accompany patients to intervention appointments
- Provide informed consent
- Have sufficient Danish skills to complete intervention sessions and data collection
- Physicians:
- specialized in hematology
- treating patients with High risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma
- work at the same department for the entire time of intervention.
- Nurses:
- treating patients with High-risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma
- work at the same department for the entire time of intervention.
Who cannot join
- Patient and caregiver are excluded if one of them is:
- Suffering from a severe psychiatric disorder
- Physicians and nurses:
- If they do not meet the inclusion criterion.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Denmark7 sites, 7 recruiting
- Recruiting
Aalborg Universitetshospital
Aalborg, 9100
Cæcilie Borregaard Myrhøj, 60701620, caecilie.borregaard.myrhoej@regionh.dk
- Recruiting
Aarhus Universitetshospital
Aarhus, 8200
Cæcilie Borregaard Myrhøj, 60701620, caecilie.borregaard.myrhoej@regionh.dk
- Recruiting
Sydvestjysk sygehus - Esbjerg
Esbjerg, 6700
Cæcilie Borregaard Myrhøj, 60701620, caecilie.borregaard.myrhoej@regionh.dk
- Recruiting
Regionshospitalet Gødstrup
Herning, 7400
Cæcilie Borregaard Myrhøj, 60701620, caecilie.borregaard.myrhoej@regionh.dk
- Recruiting
Odense Universitetshospital
Odense, 5000
Cæcilie Borregaard Myrhøj, 60701620, caecilie.borregaard.myrhoej@regionh.dk
- Recruiting
Sjællands universitetshospital Roskilde
Roskilde, 4000
Cæcilie Borregaard Myrhøj, 60701620, caecilie.borregaard.myrhoej@regionh.dk
- Recruiting
Lillebælt syge - Vejle Sygehus
Vejle, 7100
Cæcilie Borregaard Myrhøj, 60701620, caecilie.borregaard.myrhoej@regionh.dk
About this study
Official title: Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study
Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Patients with hematological cancers frequently have poor end of life outcomes, such as high treatment activity close to death, where clinical effects are doubtful, and low utilization of palliative care. Prognostic awareness and end of life (EOL) issues have urgency in the communication between patients, their caregiving relatives, and clinicians, in order to avoid futile treatments and suffering at EOL. Inspired by advanced care planning, the investigators developed the concept "Advance Consultations Concerning participants Life and Treatment" (ACT) in collaboration with a group consisting of hematologists, nurses, patients, and caregivers. The ACT concept consists of an 8-hour training day for clinicians, clinical tools, system changes, and preparation material for patients and caregivers prior to the consultation. ACT involves patients and caregivers earlier in preparation for life with chronic progressive disease and EOL-decisions, through an intervention based on compassionate communication and early planning of EOL-care. The aim of the study is to investigate the effect of the intervention on use of chemotherapy and quality of EOL-care in patients with hematological malignancy. Based on the results of the completed pilot study, the investigators are planning a nationwide 2-arm cluster randomized controlled trial where 40 physicians and 80 nurses across seven different hematological departments are randomized to either usual care or ACT training and completing ACT conversations. The investigators expect to include a total of 400 patients and their family caregivers. It is hypothesized that the ACT intervention will decrease use of futile chemotherapy, prepare patients and caregivers for difficult end-of-life-decisions, and improve quality of end-of-life care in hematology.
- Being tested
- Advance consultation concerning your life and treatment (ACT )
- Medical subject headings
- Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance consultation concerning your life and treatment (ACT )Behavioural
The ACT intervention consists of: an 8 h training day for clinicians including clinical materials such as a conversation aid and conversations guide. 6o minutes ACT-intervention sessions in daily clinic. the patients and caregivers will receive preparatory material prior for the ACT-intervention sessions, and a 30 min follow-up telephone call from the nurse within one week after the ACT-session. Clinicians will receive five sessions of followup supervision within the 24 months of intervention. The 60 min ACT-intervention session is an interdisciplinary conversation with nurse, physician, patient, and caregiver discussing issues of importance of patient and caregiver. The issues are based on the preparatory material focusing on information level and prognosis, patient's and caregiver's values, hopes, fears and worries regarding the future care with progressive disease.
| Study group | Role | What they receive |
|---|---|---|
| ACT intervention | Experimental | Participants will receive the ACT intervention Receives: Behavioral: Advance consultation concerning your life and treatment (ACT ) |
| control | No intervention | Participants will receive no intervention only usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of chemotherapy within the last 30 days of life.
Counts of patients receiving chemotherapy in the last 30 days of their life
Measured: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's anxiety symptoms
Patient reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
Measured: baseline, 3,6,9,12, and 18 months of follow-up. Investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's anxiety symptoms
Caregiver reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Secondary outcomes (26)
Number of Days of hospitalized in the last 30 days of life
Counts of days in hospital in the last 30 days of life of deceased patients
Measured: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Number of medical consultations, in the last 30 days of life
Counts of medical consultation in the last 30 days of life of deceased patients
Measured: 30 days prior to date of death,if patient dies within 18 months of follow-up period of the study
Number of patients with referral to hospice in the last 30 days of life
Referral to hospice and days from referral to death
Measured: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Survival
Overall survival
Measured: days from diagnosis to death, if patient dies within 18 months follow-up period of the study
Change from baseline through 3,6,9,12 and 18 months follow-up in Patient's quality of life
Patient reported outcome using European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire Core 15 item palliative, 4-point scale, minimum value: 1 max value 4, higher score worse outcome
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in patients' depressive symptoms
Patient reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregivers' depressive symptoms
Caregiver reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's social support
Patient reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's social support
Caregiver reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's relationship quality
Patient reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's relationship quality
Caregiver reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's satisfaction with health care
Patient reported outcome: Family Satisfaction With Advanced Cancer Care, measure on a 5-point scale where 1 is best and 5 is worst.
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's satisfaction with health care
Caregiver reported outcome: Family Satisfaction With Advanced Cancer Care, measure on a 5-point scale where 1 is best and 5 is worst.
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's prognostic understanding
Patient reported outcome: Prognostic understanding, single item questionnaire
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver Prognostic understanding
Caregiver reported outcome: Prognostic understanding, single item questionnaire
Measured: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Patient satisfaction with intervention sessions
Patient reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.
Measured: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
Caregiver Satisfaction with intervention sessions
Caregiver reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.
Measured: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
Bereaved caregivers' depressive symptoms
Caregiver reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.
Measured: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.
Bereaved caregivers' anxiety symptoms
Caregiver reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
Measured: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study
Post-traumatic stress
Bereaved caregiver reported outcome: post-traumatic stress using questionnaire "Impact of Events Scale- revised", assesses subjective distress caused by traumatic events, Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Higher score worse outcome
Measured: 1 and 6 months after patient's death, if patient dies within 18 months of follow-up period of the study
Perception of the patient's quality of death
Bereaved caregiver reported outcome: Perception of the patient's quality of death, The Views Of Informal Carers - Evaluation of Services - Short Form.
Measured: One months after patient's death, if patient dies within 18 months of follow-up period of the study
Prolonged Grief
Bereaved caregiver reported outcome: Prolonged Grief disorder. using a 5-point scale from 1-5, Higher score means worse outcome
Measured: six months after patient's death, if patient dies within 18 months of follow-up period of the study
Self-efficacy - advance care planning
Clinician reported outcome: Advance care planning self-efficacy, 5 point scale from 1-5, higher score is better outcome
Measured: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
Burnout
Clinician reported outcome: burnout (Copenhagen Burnout Inventory) 5-point scale, value 0-5, higher score means worse outcome
Measured: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
Existential communication
Clinician reported outcome: Existential communication, 5 point scale from 1-5, higher score is better outcome.
Measured: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
Satisfaction with intervention
Clinician reported outcome: satisfaction with intervention, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.
Measured: After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christoffer Johansen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Gødstrup Hospital, Aarhus University Hospital, Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Christoffer Johansen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christoffer Johansen, Professor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444348
- Sponsor's protocol ID
- P-2022-93
- Acronym
- ACT
- Status last verified
- Aug 2026
- First submitted
- 19 May 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to protocol and statistical code, as well as Individual participation data (IPD) for meta-analysis will be possible upon request. Data requestors will need to sign a data access agreement in agreement with the Data Protection Act.
Publications
Borregaard Myrhoj C, Clemmensen SN, Jarden M, Johansen C, von Heymann A. Compassionate Communication and Advance Care Planning to improve End-of-life Care in Treatment of Haematological Disease 'ACT': Study Protocol for a Cluster-randomized trial. BMJ Open. 2024 May 21;14(5):e085163. doi: 10.1136/bmjopen-2024-085163.
PubMed 38772898
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05444348
- Acronym / sponsor ID
- ACT / P-2022-93
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- Christoffer JohansenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Gødstrup Hospital, Aarhus University Hospital, Aalborg University Hospital
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Patients with hematological cancers frequently have poor end of life outcomes, such as high treatment activity close to death, where clinical effects are doubtful, and low utilization of palliative care. Prognostic awareness and end of life (EOL) issues have urgency in the communication between patients, their caregiving relatives, and clinicians, in order to avoid futile treatments and suffering at EOL. Inspired by advanced care planning, the investigators developed the concept "Advance Consultations Concerning participants Life and Treatment" (ACT) in collaboration with a group consisting of hematologists, nurses, patients, and caregivers. The ACT concept consists of an 8-hour training day for clinicians, clinical tools, system changes, and preparation material for patients and caregivers prior to the consultation. ACT involves patients and caregivers earlier in preparation for life with chronic progressive disease and EOL-decisions, through an intervention based on compassionate communication and early planning of EOL-care. The aim of the study is to investigate the effect of the intervention on use of chemotherapy and quality of EOL-care in patients with hematological malignancy. Based on the results of the completed pilot study, the investigators are planning a nationwide 2-arm cluster randomized controlled trial where 40 physicians and 80 nurses across seven different hematological departments are randomized to either usual care or ACT training and completing ACT conversations. The investigators expect to include a total of 400 patients and their family caregivers. It is hypothesized that the ACT intervention will decrease use of futile chemotherapy, prepare patients and caregivers for difficult end-of-life-decisions, and improve quality of end-of-life care in hematology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT intervention | Experimental | Behavioral: Advance consultation concerning your life and treatment (ACT )Participants will receive the ACT intervention |
| control | No intervention | –Participants will receive no intervention only usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Be at least 18 years of age
- Have a diagnosis of one of the following:
- High-risk myelodysplastic syndrome (MDS) or MDS with overlap of myeloproliferative neoplasms (high-risk MDS/MPN),
- Acute myeloid leukemia(AML): Age≥80 or in palliative treatment or relapse
- Lymphoma: Age≥80 or relapse or refractory or palliative treatment
Key exclusion criteria (4 listed)
- Suffering from a severe psychiatric disorder
- If they do not meet the inclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance consultation concerning your life and treatment (ACT )The ACT intervention consists of: an 8 h training day for clinicians including clinical materials such as a conversation aid and conversations guide. 6o minutes ACT-intervention sessions in daily clinic. the patients and caregivers will receive preparatory material prior for the ACT-intervention sessions, and a 30 min follow-up telephone call from the nurse within one week after the ACT-session. Clinicians will receive five sessions of followup supervision within the 24 months of intervention. The 60 min ACT-intervention session is an interdisciplinary conversation with nurse, physician, patient, and caregiver discussing issues of importance of patient and caregiver. The issues are based on the preparatory material focusing on information level and prognosis, patient's and caregiver's values, hopes, fears and worries regarding the future care with progressive disease. | Behavioural | ACT intervention |
Primary outcome
Use of chemotherapy within the last 30 days of life.
Time frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Counts of patients receiving chemotherapy in the last 30 days of their life
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's anxiety symptoms
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. Investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Patient reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's anxiety symptoms
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Caregiver reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
26 secondary outcomes
Number of Days of hospitalized in the last 30 days of life
Time frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Number of medical consultations, in the last 30 days of life
Time frame: 30 days prior to date of death,if patient dies within 18 months of follow-up period of the study
Number of patients with referral to hospice in the last 30 days of life
Time frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Survival
Time frame: days from diagnosis to death, if patient dies within 18 months follow-up period of the study
Change from baseline through 3,6,9,12 and 18 months follow-up in Patient's quality of life
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in patients' depressive symptoms
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregivers' depressive symptoms
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's social support
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's social support
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's relationship quality
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's relationship quality
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's satisfaction with health care
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's satisfaction with health care
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's prognostic understanding
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver Prognostic understanding
Time frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Patient satisfaction with intervention sessions
Time frame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
Caregiver Satisfaction with intervention sessions
Time frame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
Bereaved caregivers' depressive symptoms
Time frame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.
Bereaved caregivers' anxiety symptoms
Time frame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study
Post-traumatic stress
Time frame: 1 and 6 months after patient's death, if patient dies within 18 months of follow-up period of the study
Perception of the patient's quality of death
Time frame: One months after patient's death, if patient dies within 18 months of follow-up period of the study
Prolonged Grief
Time frame: six months after patient's death, if patient dies within 18 months of follow-up period of the study
Self-efficacy - advance care planning
Time frame: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
Burnout
Time frame: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
Existential communication
Time frame: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
Satisfaction with intervention
Time frame: After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 38772898Borregaard Myrhoj C, Clemmensen SN, Jarden M, Johansen C, von Heymann A. Compassionate Communication and Advance Care Planning to improve End-of-life Care in Treatment of Haematological Disease 'ACT': Study Protocol for a Cluster-randomized trial. BMJ Open. 2024 May 21;14(5):e085163. doi: 10.1136/bmjopen-2024-085163.
- Individual participant dataSharing planned: Yes. Access to protocol and statistical code, as well as Individual participation data (IPD) for meta-analysis will be possible upon request. Data requestors will need to sign a data access agreement in agreement with the Data Protection Act.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoffer Johansen, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance consultation concerning your life and treatment (ACT ) in people with Multiple Myeloma and Myelodysplastic Syndromes, run by Christoffer Johansen at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cæcilie Borregaard Myrhøj, MScN (+45 60701620, caecilie.borregaard.myrhoej@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of chemotherapy within the last 30 days of life. (time frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.