Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT

Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT - a Two Site Feasibility Study

Sponsors

Lead Sponsor: Rigshospitalet, Denmark

Collaborator: Novo Nordisk A/S

Source Rigshospitalet, Denmark
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).

Detailed Description

A prospective, non-randomized, feasibility study examining a systematic approach to symptom management using PROMs with 12 months of follow up in hematological outpatient clinic

Overall Status Recruiting
Start Date 2021-04-30
Completion Date 2025-05-01
Primary Completion Date 2023-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Recruitment rate Recruiment time frame: 12 months
Adherence to intervention Intervention time frame: 12 months of follow up
Secondary Outcome
Measure Time Frame
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
Enrollment 30
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Lee Symptom Scala

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

Arm Group Label: Symptom management with Lee Symptom Scale

Eligibility

Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Mary Jarden Principal Investigator Rigshospitalet, Denmark
Overall Contact

Last Name: Maja Pedersen, Ph.d. student

Phone: +4535456825

Email: [email protected]

Location
Facility: Status: Contact: Rigshospitalet Maja o Pedersen +4535456825 [email protected]
Location Countries

Denmark

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rigshospitalet, Denmark

Investigator Full Name: Mary Jarden

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Symptom management with Lee Symptom Scale

Type: Experimental

Description: 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.

Acronym SIMPly-CARE
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

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