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

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.

Study Overview

• Status: Unknown
• Conditions: Hematological Cancer
• Intervention / Treatment: Other: Completion of patient-reported outcome (PRO) questionnaires

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 Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nana Brochmann, MD; Phone Number: +4522833458 +4522833458; Email: nmor@regionsjaelland.dk
• Study Contact Backup: Name: Hans Hasselbalch, professor; Phone Number: +4526223678 +4526223678; Email: hans.hasselbalch@gmail.com

Study Locations

• Denmark
  • Zealand
    • Roskilde, Zealand, Denmark, 4000
      • Recruiting
      • Department of Hematology, Zealand University Hospital
      • Contact: Nana Brochmann, MD; Phone Number: +4522833458 +4522833458; Email: nmor@regionsjaelland.dk
      • Contact: Hans Hasselbalch, professor; Phone Number: +4526223678 +4526223678; Email: hans.hasselbalch@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Three and a half year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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?	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?	Three and a half year

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Study Chair: Hans Hasselbalch, professor, Department of Hematology, Zealand University Hospital, Vestermarksvej 9, 4000 Roskilde, Denmark

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: supportive care; patient-reported outcomes; clinical practice; hematological cancer
• Other Study ID Numbers: REG-72-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO