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

Z

Zealand University Hospital

Status

Unknown

Conditions

Hematological Cancer

Treatments

Other: Completion of patient-reported outcome (PRO) questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT03056469
REG-72-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

225 participants in 3 patient groups

Care providers do have access to PROs
Active Comparator group
Description:
Participants complete patient-reported outcome (PRO) questionnaires. Care providers do have access to the PROs and use them in clinical decision making.
Treatment:
Other: Completion of patient-reported outcome (PRO) questionnaires
Care providers do not have access to PROs
Active Comparator group
Description:
The participants complete patient-reported outcome (PRO) questionnaires. Care providers do not have access to the PROs.
Treatment:
Other: Completion of patient-reported outcome (PRO) questionnaires
Control group
No Intervention group
Description:
Standard follow-up. The participants do not complete PRO questionnaires.

Trial contacts and locations

0

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Central trial contact

Hans Hasselbalch, professor; Nana Brochmann, MD

Data sourced from clinicaltrials.gov

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