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

NCT03056469 | Unknown

• 1 other identifier: REG-72-2016
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Cancer

Keywords

patient-reported outcomes; supportive care; clinical practice; hematological cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patients satisfaction with the interventions done by a department of hematology

  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

• Contacts to the outpatient clinic at department of hematology

  Three and a half year

• Paraclinical interventions

  Three and a half year

Study Arms (3)

Care providers do have access to PROs

ACTIVE COMPARATOR

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

Care providers do not have access to PROs

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Standard follow-up. The participants do not complete PRO questionnaires.

Interventions

Completion of patient-reported outcome (PRO) questionnaires OTHER

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.

Care providers do have access to PROs; Care providers do not have access to PROs

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Hematology, Zealand University Hospital

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 32217877 DERIVED

MeSH Terms

Interventions

prolyl-proline; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hans Hasselbalch, professor

  Department of Hematology, Zealand University Hospital, Vestermarksvej 9, 4000 Roskilde, Denmark

  STUDY CHAIR

Central Study Contacts

Nana Brochmann, MD

CONTACT

+4522833458; nmor@regionsjaelland.dk

Hans Hasselbalch, professor

CONTACT

+4526223678; hans.hasselbalch@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 17, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)