Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT (SIMPly-CARE)

Rigshospitalet

Status: Completed

Conditions: Hematological Malignancy; GVHD, Chronic

Treatments: Behavioral: Lee Symptom Scala

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04884204

Copenhagen, Rigshospitalet

Details and patient eligibility

About

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).

Full 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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Symptom management with Lee Symptom Scale

Experimental group

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.

Treatment:

Behavioral: Lee Symptom Scala