Hematologic MalignancySIMPly-CARENCT04757545
Symptom Identification and Management in Patients With Hematological Malignancy During Follow-up Care
A study testing HM-PRO in people with Hematologic Malignancy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed PRO (HM-PRO) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- HM-PRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- adults > 18 years
- diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, Rigshospitalet
- The patients can be included approximately six months after initial diagnosis if in stable condition.
- able to manage an e-mail account
Who cannot join
- Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptom Identification and Management in Patiens With Hematological Malignacy - A Randomized Controlled Trial Using HM-PRO
The aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed PRO (HM-PRO) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy.
Read the detailed description
Design: A two-arm prospective randomized controlled trial.
Population: Patients diagnosed with chronic myeloid leukemia (CML), clonal cytopenia of unknown significance (CCUS), myelodysplastic syndrome (MDS) or myeloproliferative neoplasia (MPN).
Patients will be recruited from the outpatient clinic at the Dept. of Hematology at Rigshospitalet in Denmark. Patients will be identified and screened by their physician. Patients who are eligible for study inclusion will hereafter be approached, informed and recruited by the primary research investigator. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.
The intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients.
The control group will receive standard care in the outpatient clinic. The patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control.
Data Collection: The questionnaires will be distributed and completed by patients electronically via REDCap consisting of clinical data, PRO data (HM-PRO) and endpoint measures (see below).
- Primary outcome: Change in QoL measured by EORTC-QLQ-C30, global health domain, at 12 months.
- Secondary outcomes: Change in symptoms of depression and anxiety measured by HADS, change in symptom burden measured by MDASI symptom scale and clinical data outcomes at 12 months.
- Conditions
- Hematologic Malignancy
- Being tested
- HM-PRO
- Keywords
- HM-PRO, Symptom management, Patient reported outcome
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM-PROOther
The intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients:
- Worsening in symptoms results in a nurse-led telephone consultation within two days guided by the symptom management manual.
- Minor changes in patient's symptom assessment result in a nurse-led telephone consultation within seven days using the symptom management manual.
- Patients that are completely stable in the symptom assessment will receive an electronic answer via min-SP (electronic patient journal) regarding the results and a new appointment, including PRO-data prior to this.
| Study group | Role | What they receive |
|---|---|---|
| HM-PRO intervention | Active comparator | The intervention group will have a predetermined nurseled consultation planned to assess medical status and symptom control at 0, 6 and 12 months. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients. Receives: Other: HM-PRO |
| Standard outpatient follow-up care | No intervention | The control group will receive standard care in the outpatient clinic. The patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health related quality og life: EORTC QLQ C30
The global health domain
Measured: At 12 months
Secondary outcomes (11)
Changes in symptoms of depression and anxiety measured by HADS
Hospital Anxiety and Depression score
Measured: 6 and 12 months
Changes in symptom burden measured by MDASI symptom scale
MD Andersons Scale - core
Measured: 6 and 12 months
Clinical outcomes
Hematological diagnosis
Measured: At baseline
Patient experiences measured at PREM
Patient reported experience measures
Measured: 6 and 12 months
Clinical outcome
Time of diagnosis - date
Measured: Date for time of diagnosis - collected at baseline
Clinical outcome
Frequency/dates and length of hospitalization
Measured: Hospitalization during intervention period baseline - 12 months
Clinical outcome
Referrals to other departments and/or primary care in the municipality
Measured: Number and charecter of referrals during interventions period baseline - 12 months
Clinical outcome
Add on medication
Measured: From baseline - 12 months
Clinical medication
Medication at baseline
Measured: Baseline
Clinical outcome
Number of consultations in follow-up in dept. of hematology
Measured: From baseline -12 months
Clinical outcome
CPR - from laboratory test
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start8 Feb 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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 Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Model description
- Two armed randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Mary Jarden, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Maja Pedersen, Ph.d. stud., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757545
- Sponsor's protocol ID
- University Hospital Copenhagen
- Acronym
- SIMPly-CARE
- Status last verified
- Nov 2023
- First submitted
- 12 Feb 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen M, Larsen MT, Kornblit BT, Dahl EO, Lomborg K, Tolver A, Jarden M. Effects of nurse-led symptom management in chronic myeloid malignancies: a randomized trial. Support Care Cancer. 2025 Feb 15;33(3):196. doi: 10.1007/s00520-025-09230-1.
PubMed 39954038
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Identification and Management in Patiens With Hematological Malignacy - A Randomized Controlled Trial Using HM-PRO
- ClinicalTrials.gov ID
- NCT04757545
- Acronym / sponsor ID
- SIMPly-CARE / University Hospital Copenhagen
- Conditions
- Hematologic Malignancy
- Keywords
- HM-PRO, Symptom management, Patient reported outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 Feb 2021 (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.
The aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed PRO (HM-PRO) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy.
Detailed description
Design: A two-arm prospective randomized controlled trial.
Population: Patients diagnosed with chronic myeloid leukemia (CML), clonal cytopenia of unknown significance (CCUS), myelodysplastic syndrome (MDS) or myeloproliferative neoplasia (MPN).
Patients will be recruited from the outpatient clinic at the Dept. of Hematology at Rigshospitalet in Denmark. Patients will be identified and screened by their physician. Patients who are eligible for study inclusion will hereafter be approached, informed and recruited by the primary research investigator. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.
The intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients.
The control group will receive standard care in the outpatient clinic. The patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control.
Data Collection: The questionnaires will be distributed and completed by patients electronically via REDCap consisting of clinical data, PRO data (HM-PRO) and endpoint measures (see below).
- Primary outcome: Change in QoL measured by EORTC-QLQ-C30, global health domain, at 12 months.
- Secondary outcomes: Change in symptoms of depression and anxiety measured by HADS, change in symptom burden measured by MDASI symptom scale and clinical data outcomes at 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two armed randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HM-PRO intervention | Active comparator | Other: HM-PROThe intervention group will have a predetermined nurseled consultation planned to assess medical status and symptom control at 0, 6 and 12 months. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients. |
| Standard outpatient follow-up care | No intervention | –The control group will receive standard care in the outpatient clinic. The patient has a predetermined consultation appointment at the hospital one time a year with a doctor to evaluate medical status and symptom control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults > 18 years
- diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, Rigshospitalet
- The patients can be included approximately six months after initial diagnosis if in stable condition.
- able to manage an e-mail account
Key exclusion criteria (1 listed)
- Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
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 |
|---|---|---|
| HM-PROThe intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients: 1. Worsening in symptoms results in a nurse-led telephone consultation within two days guided by the symptom management manual. 2. Minor changes in patient's symptom assessment result in a nurse-led telephone consultation within seven days using the symptom management manual. 3. Patients that are completely stable in the symptom assessment will receive an electronic answer via min-SP (electronic patient journal) regarding the results and a new appointment, including PRO-data prior to this. | Other | HM-PRO intervention |
Primary outcome
Change in Health related quality og life: EORTC QLQ C30
Time frame: At 12 months
The global health domain
11 secondary outcomes
Changes in symptoms of depression and anxiety measured by HADS
Time frame: 6 and 12 months
Changes in symptom burden measured by MDASI symptom scale
Time frame: 6 and 12 months
Clinical outcomes
Time frame: At baseline
Patient experiences measured at PREM
Time frame: 6 and 12 months
Clinical outcome
Time frame: Date for time of diagnosis - collected at baseline
Clinical outcome
Time frame: Hospitalization during intervention period baseline - 12 months
Clinical outcome
Time frame: Number and charecter of referrals during interventions period baseline - 12 months
Clinical outcome
Time frame: From baseline - 12 months
Clinical medication
Time frame: Baseline
Clinical outcome
Time frame: From baseline -12 months
Clinical outcome
Time frame: Baseline, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39954038Pedersen M, Larsen MT, Kornblit BT, Dahl EO, Lomborg K, Tolver A, Jarden M. Effects of nurse-led symptom management in chronic myeloid malignancies: a randomized trial. Support Care Cancer. 2025 Feb 15;33(3):196. doi: 10.1007/s00520-025-09230-1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maja Pedersen, Ph.d. stud. principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HM-PRO in people with Hematologic Malignancy, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health related quality og life: EORTC QLQ C30 (time frame: At 12 months). 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 NCT04757545, 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 28 Nov 2023.