NCT04884204

Brief Summary

A two sited feasibility study to test the feasibility of systematic symptom identification with disease specific and clinically developed PROM (Lee Symptom Scale) longitudinally with a 12 month follow up in outpatient care in patients post HSCT to assess symptoms of chronic GVHD (n= 30).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

April 30, 2021

Last Update Submit

November 26, 2023

Conditions

GVHD, ChronicHematological Malignancy

Keywords

Lee Symptom ScaleSymptom managementPatient reported outcome

Outcome Measures

Primary Outcomes (2)

  • Recruitment rate

    Number of participants included from eligible participants

    Recruiment time frame: 12 months

  • Adherence to intervention

    Number of visits completed out of planned visits during intervention

    Intervention time frame: 12 months of follow up

Secondary Outcomes (4)

  • Quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30 (EORTC-QLQ-C30)

    12 months; at baseline (0 months), 6 and 12 months

  • Depression and Anxiety measured with the Hospital Anxiety and Depression Scale

    12 months; at baseline (0 months), 6 and 12 months

  • MD Andersons Symptom Inventory (MDASI)

    12 months; at baseline (0 months), 6 and 12 months

  • HM-PRO questionaire developed by the 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association

    12 months; at baseline (0 months), 3, 6, 9 and 12 months

Other Outcomes (9)

  • Diagnose

    At baseline

  • Medication

    At baseline

  • Immunosuppresive drugs

    12 months of follow up from date of transplantation

  • +6 more other outcomes

Study Arms (1)

Symptom management with Lee Symptom Scale

EXPERIMENTAL

Participants will receive disease specific questionnaires electronically, cGVHD-PRO (Lee Symtpom Scale), one week prior to their scheduled visit in the outpatient clinic. The participants will be asked to answer the questionnaire from home without any involvement from clinicians. Afterwards the PRO data will be used during the scheduled clinical consultations as an instrument to discover symptoms on chronic GVHD and systematically to monitoring symptoms developing over time.

Behavioral: Lee Symptom Scala

Interventions

Lee Symptom ScalaBEHAVIORAL

Symptom identification and management with Lee Symptom Scale in follow up care

Symptom management with Lee Symptom Scale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> 18 years old
  • Approximately 3 months post HSCT (they will be included before HSCT, but the intervention will begin at 3 moths).
  • Patients included needs to be able to manage a computer to receive and respond to collect PRO data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans SyndromeHematologic Neoplasms

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mary Jarden

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 12, 2021

Study Start

April 30, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

DK(1)