Hematological CancerNCT03056469
Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer
A study testing Completion of patient-reported outcome (PRO) questionnaires in people with Hematological Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
This study investigates if integration of patient-reported outcomes in the follow-up of patients with newly diagnosed, not curable, chronic hematological cancer changes the number and kind of supportive care interventions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hematological Cancer
- What is being tested?
- Completion of patient-reported outcome (PRO) questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Dec 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients newly diagnosed with not curable, chronic hematological cancer
- ≥18 years old
- oral and written informed consent
Who cannot join
- participation in another intervention study
- psychological or physiological conditions that may prevent compliance/adherence to the study
- patients do not wish to be included in the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Hematology, Zealand University Hospital
Roskilde, Region Sjælland, 4000
Nana Brochmann, MD, +4522833458 ext. +4522833458, nmor@regionsjaelland.dk
Hans Hasselbalch, professor, +4526223678 ext. +4526223678, hans.hasselbalch@gmail.com
About this study
This study investigates if integration of patient-reported outcomes in the follow-up of patients with newly diagnosed, not curable, chronic hematological cancer changes the number and kind of supportive care interventions. Furthermore, this study investigates if the patients feel that they are more involved in a positive way when patient-reported outcomes are integrated in the follow-up of their cancer.
Read the detailed description
This is a multimethod study. It has a quantitative and a qualitative part. The patient-reported outcome questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30) and the patient-reported outcome and patient-reported experience questionnaire The Outcomes and Experiences Questionnaire (OEQ) are completed by the included patients within one week before a patient-physician consultation at the outpatient clinic at one single department of hematology. Baseline is different for different patient groups; 1) for participants receiving a primary treatment baseline is defined as the first patient-physician consultation after the primary treatment ended, 2) for patients continuously receiving medical treatment baseline is defined as the first patient-physician consultation after starting medical treatment, and 3) for patients followed using a watch and wait strategy baseline is defined as the first patient-physician consultation after deciding the watch and wait strategy. Each patient completes the questionnaires for 2 years. The questionnaires can be completed online or on paper depending on the patients choice. Answers from both questionnaires are eligible to all health care professionals in the outpatient clinic in an internet-based tool. A summary of scores from the EORTC QLQ C-30, and the answers and the score from the OEQ, are written in the medical record.
This study investigates, if use of the patient-reported outcome (PRO) questionnaires are useful in the assessment of the patients needs and health care providers decision making regarding supportive care interventions. It investigates, if completion of PRO questionnaires changes the number and kind of supportive care interventions.
Observations of patient-physician consultations and individual interviews with patients are used to capture the impact of the questionnaires on the consultations and patients evaluation of the use of the questionnaires.
This study also investigates, if patients completion of PRO questionnaires and health care professionals use of the questionnaires in clinical decision making changes the number of contacts between patients and a department of hematology and the number of paraclinical interventions.
- Conditions
- Hematological Cancer
- Being tested
- Completion of patient-reported outcome (PRO) questionnaires
- Keywords
- patient-reported outcomes, supportive care, clinical practice, hematological cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of patient-reported outcome (PRO) questionnairesOther
Patient-reported outcome (PRO) questionnaires are completed at home within one week before a patient-physician consultation at the outpatient clinic. The questionnaires are submitted online or on paper depending on the participants choice.
| Study group | Role | What they receive |
|---|---|---|
| Care providers do have access to PROs | Active comparator | Participants complete patient-reported outcome (PRO) questionnaires. Care providers do have access to the PROs and use them in clinical decision making. Receives: Other: Completion of patient-reported outcome (PRO) questionnaires |
| Care providers do not have access to PROs | Active comparator | The participants complete patient-reported outcome (PRO) questionnaires. Care providers do not have access to the PROs. Receives: Other: Completion of patient-reported outcome (PRO) questionnaires |
| Control group | No intervention | Standard follow-up. The participants do not complete PRO questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supportive care interventions
Number and kind of supportive care interventions are registered. Supportive care actions are defined as: a) a plan for rehabilitation, b) an intervention by a physiotherapist, occupational therapist, dietician, or social worker, c) consultation with a psychologist or talk with a priest, d) an intervention done by a general practitioner because of the hematological cancer after contact between the hematological department and the general practitioner, e) use of offers like group talks etc offered by the Danish Cancer Society, or f) other supportive care interventions
Measured: Three and a half year
Secondary outcomes (4)
Patients satisfaction with the interventions done by a department of hematology
Patients satisfaction with the interventions done by a department of hematology are measured using a patient-reported experience questionnaire
Measured: Three and a half year
Impact of the use of PRO questionnaires on the consultation and patient satisfaction with and evaluation of the use of patient-reported outcomes in the outpatient clinic
The impact of the use of PRO questionnaires on the consultation and patients satisfaction with and evaluation of the use of patient-reported outcomes in the outpatient clinic are investigated by observation of conversations between doctors and patients in the outpatient clinic, and furthermore investigated by individual interviews
Measured: Three and a half year
Contacts to the outpatient clinic at department of hematology
All contacts between the patients and the department of hematology are registered. Are there more/less/equal number and kind of contacts to the outpatient clinic at department of hematology when using patient-reported outcomes compared to when not using patient-reported outcomes?
Measured: Three and a half year
Paraclinical interventions
All paraclinical actions ordered by the department of hematology are registered. Are more/less/equal number and kind of paraclinical interventions done when using patient-reported outcomes compared to when not using patient-reported outcomes?
Measured: Three and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startSep 2016
- Primary completionMar 2020 (estimated)
- Study completionDec 2021 (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 Hematological CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Hasselbalch, professor, Study chair, Department of Hematology, Zealand University Hospital, Vestermarksvej 9, 4000 Roskilde, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056469
- Sponsor's protocol ID
- REG-72-2016
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thestrup Hansen S, Kjerholt M, Friis Christensen S, Brodersen J, Holge-Hazelton B. Nurses' Experiences When Introducing Patient-Reported Outcome Measures in an Outpatient Clinic: An Interpretive Description Study. Cancer Nurs. 2021 Mar-Apr 01;44(2):E108-E120. doi: 10.1097/NCC.0000000000000808.
PubMed 32217877
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer
- ClinicalTrials.gov ID
- NCT03056469
- Acronym / sponsor ID
- REG-72-2016
- Conditions
- Hematological Cancer
- Keywords
- patient-reported outcomes, supportive care, clinical practice, hematological cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Feb 2017 (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.
This study investigates if integration of patient-reported outcomes in the follow-up of patients with newly diagnosed, not curable, chronic hematological cancer changes the number and kind of supportive care interventions. Furthermore, this study investigates if the patients feel that they are more involved in a positive way when patient-reported outcomes are integrated in the follow-up of their cancer.
Detailed description
This is a multimethod study. It has a quantitative and a qualitative part. The patient-reported outcome questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30) and the patient-reported outcome and patient-reported experience questionnaire The Outcomes and Experiences Questionnaire (OEQ) are completed by the included patients within one week before a patient-physician consultation at the outpatient clinic at one single department of hematology. Baseline is different for different patient groups; 1) for participants receiving a primary treatment baseline is defined as the first patient-physician consultation after the primary treatment ended, 2) for patients continuously receiving medical treatment baseline is defined as the first patient-physician consultation after starting medical treatment, and 3) for patients followed using a watch and wait strategy baseline is defined as the first patient-physician consultation after deciding the watch and wait strategy. Each patient completes the questionnaires for 2 years. The questionnaires can be completed online or on paper depending on the patients choice. Answers from both questionnaires are eligible to all health care professionals in the outpatient clinic in an internet-based tool. A summary of scores from the EORTC QLQ C-30, and the answers and the score from the OEQ, are written in the medical record.
This study investigates, if use of the patient-reported outcome (PRO) questionnaires are useful in the assessment of the patients needs and health care providers decision making regarding supportive care interventions. It investigates, if completion of PRO questionnaires changes the number and kind of supportive care interventions.
Observations of patient-physician consultations and individual interviews with patients are used to capture the impact of the questionnaires on the consultations and patients evaluation of the use of the questionnaires.
This study also investigates, if patients completion of PRO questionnaires and health care professionals use of the questionnaires in clinical decision making changes the number of contacts between patients and a department of hematology and the number of paraclinical interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care providers do have access to PROs | Active comparator | Other: Completion of patient-reported outcome (PRO) questionnairesParticipants complete patient-reported outcome (PRO) questionnaires. Care providers do have access to the PROs and use them in clinical decision making. |
| Care providers do not have access to PROs | Active comparator | Other: Completion of patient-reported outcome (PRO) questionnairesThe participants complete patient-reported outcome (PRO) questionnaires. Care providers do not have access to the PROs. |
| Control group | No intervention | –Standard follow-up. The participants do not complete PRO questionnaires. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients newly diagnosed with not curable, chronic hematological cancer
- ≥18 years old
- oral and written informed consent
Key exclusion criteria (3 listed)
- participation in another intervention study
- psychological or physiological conditions that may prevent compliance/adherence to the study
- patients do not wish to be included in the 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 |
|---|---|---|
| Completion of patient-reported outcome (PRO) questionnairesPatient-reported outcome (PRO) questionnaires are completed at home within one week before a patient-physician consultation at the outpatient clinic. The questionnaires are submitted online or on paper depending on the participants choice. | Other | Care providers do have access to PROs, Care providers do not have access to PROs |
Primary outcome
Supportive care interventions
Time frame: Three and a half year
Number and kind of supportive care interventions are registered. Supportive care actions are defined as: a) a plan for rehabilitation, b) an intervention by a physiotherapist, occupational therapist, dietician, or social worker, c) consultation with a psychologist or talk with a priest, d) an intervention done by a general practitioner because of the hematological cancer after contact between the hematological department and the general practitioner, e) use of offers like group talks etc offered by the Danish Cancer Society, or f) other supportive care interventions
4 secondary outcomes
Patients satisfaction with the interventions done by a department of hematology
Time frame: Three and a half year
Impact of the use of PRO questionnaires on the consultation and patient satisfaction with and evaluation of the use of patient-reported outcomes in the outpatient clinic
Time frame: Three and a half year
Contacts to the outpatient clinic at department of hematology
Time frame: Three and a half year
Paraclinical interventions
Time frame: Three and a half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Derived from this study: PubMed 32217877Thestrup Hansen S, Kjerholt M, Friis Christensen S, Brodersen J, Holge-Hazelton B. Nurses' Experiences When Introducing Patient-Reported Outcome Measures in an Outpatient Clinic: An Interpretive Description Study. Cancer Nurs. 2021 Mar-Apr 01;44(2):E108-E120. doi: 10.1097/NCC.0000000000000808.
- 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.
Hans Hasselbalch, professor study chair
Department of Hematology, Zealand University Hospital, Vestermarksvej 9, 4000 Roskilde, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Completion of patient-reported outcome (PRO) questionnaires in people with Hematological Cancer, run by Zealand University Hospital 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nana Brochmann, MD (+4522833458 ext. +4522833458, nmor@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supportive care interventions (time frame: Three and a half year). 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 NCT03056469, 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 17 Feb 2017.