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Clinical Trials/NCT03056469
NCT03056469
Unknown
N/A

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

Zealand University Hospital1 site in 1 country225 target enrollmentSeptember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hematological Cancer
Sponsor
Zealand University Hospital
Enrollment
225
Locations
1
Primary Endpoint
Supportive care interventions
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
December 2021
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Contacts to the outpatient clinic at department of hematology(Three and a half year)
  • Patients satisfaction with the interventions done by a department of hematology(Three and a half year)
  • Paraclinical interventions(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(Three and a half year)

Study Sites (1)

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