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NCT Number: NCT04884204

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

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).

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Key information

Conditions

GVHD, Chronic Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Hematologic Diseases Hematologic Neoplasms Hematological Malignancy Hemic and Lymphatic Diseases Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neoplasms Neoplasms by Site Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lee Symptom Scala

Behavioral

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

Primary outcomes

  1. Recruitment rate

    Time frame: Recruiment time frame: 12 months

    Number of participants included from eligible participants

  2. Adherence to intervention

    Time frame: Intervention time frame: 12 months of follow up

    Number of visits completed out of planned visits during intervention

Secondary outcomes

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

    Time frame: 12 months; at baseline (0 months), 6 and 12 months

    Change in quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30

  2. Depression and Anxiety measured with the Hospital Anxiety and Depression Scale

    Time frame: 12 months; at baseline (0 months), 6 and 12 months

    Change in symptoms of depression and anxiety measured by the Hospital Anxiety Depression Scale

  3. MD Andersons Symptom Inventory (MDASI)

    Time frame: 12 months; at baseline (0 months), 6 and 12 months

    Change in symptom burden measured by the scale M.D. Andersons Symptom Inventory

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

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

    Change in HM-PRO developed by The 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association

Other outcomes

  1. Diagnose

    Time frame: At baseline

    Diagnose at baseline

  2. Medication

    Time frame: At baseline

    Medication at baseline

  3. Immunosuppresive drugs

    Time frame: 12 months of follow up from date of transplantation

    Immunosuppresive drugs the participants receive after transplantation (within the study period)

  4. Hospitalization

    Time frame: 12 months of follow up from date of transplantation

    Periods with hospitalizations within the study period

  5. Referrals to other hospital departments

    Time frame: 12 months of follow up from date of transplantation

    Number of referrals to other hospital departments within the study period

  6. Referrals to general practitioner

    Time frame: 12 months of follow up from date of transplantation

    Number referrals to general practitioner within the study period

  7. Referrals to municipality

    Time frame: 12 months of follow up from date of transplantation

    Number of referrals to rehabilitation in the municipality within the study period

  8. Infections treated with antibiotics

    Time frame: 12 months of follow up from date of transplantation

    Number of infections treated with antibiotics within the study period

  9. Number of telephone contacts to Dept. of Hematology

    Time frame: 12 months of follow up from date of transplantation

    Number of telephone contacts to Dept. of Hematology within the study period

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: SIMPly-CARE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 12, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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