Clinical trial NCT03056469: Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer
Official title: Patient-Reported Outcomes Integrated in the Follow-up of Patients With Hematological Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematological Cancer
Keywords: patient-reported outcomes
supportive care
clinical practice
hematological cancer
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Supportive care interventions
timeFrame: Three and a half year
Secondary outcomes:
measure: Patients satisfaction with the interventions done by a department of hematology
timeFrame: Three and a half year
measure: 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
timeFrame: Three and a half year
measure: Contacts to the outpatient clinic at department of hematology
timeFrame: Three and a half year
measure: Paraclinical interventions
timeFrame: Three and a half year
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of Hematology, Zealand University Hospital
state: Zealand
Study officials:
affiliation: Department of Hematology, Zealand University Hospital, Vestermarksvej 9, 4000 Roskilde, Denmark
name: Hans Hasselbalch, professor
role: STUDY_CHAIR
References:
citation: 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.