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Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056469
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hematological Cancer Other: Completion of patient-reported outcome (PRO) questionnaires Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: In one randomization arm the participants submit patient-reported outcomes, and the care providers have access to the patient-reported outcomes. In another randomization arm the participants submit patient-reported outcomes, but the care providers do not have access to the patient-reported outcomes. In the last randomization arm the participants are randomized to standard follow-up, do not complete PRO questionnaires and are thus controls.
Primary Purpose: Supportive Care
Official Title: Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Active Comparator: Care providers do have access to PROs
Participants complete patient-reported outcome (PRO) questionnaires. Care providers do have access to the PROs and use them in clinical decision making.
Other: Completion of patient-reported outcome (PRO) questionnaires
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.

Active Comparator: Care providers do not have access to PROs
The participants complete patient-reported outcome (PRO) questionnaires. Care providers do not have access to the PROs.
Other: Completion of patient-reported outcome (PRO) questionnaires
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.

No Intervention: Control group
Standard follow-up. The participants do not complete PRO questionnaires.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patients satisfaction with the interventions done by a department of hematology [ Time Frame: Three and a half year ]
    Patients satisfaction with the interventions done by a department of hematology are measured using a patient-reported experience questionnaire

  2. 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 ]
    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

  3. Contacts to the outpatient clinic at department of hematology [ Time Frame: Three and a half year ]
    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?

  4. Paraclinical interventions [ Time Frame: Three and a half year ]
    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?



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients newly diagnosed with not curable, chronic hematological cancer
  • ≥18 years old
  • oral and written informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056469


Contacts
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Contact: Nana Brochmann, MD +4522833458 ext +4522833458 nmor@regionsjaelland.dk
Contact: Hans Hasselbalch, professor +4526223678 ext +4526223678 hans.hasselbalch@gmail.com

Locations
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Denmark
Department of Hematology, Zealand University Hospital Recruiting
Roskilde, Zealand, Denmark, 4000
Contact: Nana Brochmann, MD    +4522833458 ext +4522833458    nmor@regionsjaelland.dk   
Contact: Hans Hasselbalch, professor    +4526223678 ext +4526223678    hans.hasselbalch@gmail.com   
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Study Chair: Hans Hasselbalch, professor Department of Hematology, Zealand University Hospital, Vestermarksvej 9, 4000 Roskilde, Denmark
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03056469    
Other Study ID Numbers: REG-72-2016
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zealand University Hospital:
patient-reported outcomes
supportive care
clinical practice
hematological cancer