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Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis

Sponsor
Uppsala University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06065007
Collaborator
Karolinska Institutet (Other)
400
Enrollment
2
Locations
61
Anticipated Duration (Months)
200
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Systemic Mastocytosis is a rare and complex disease caused by accumulation of mast cells. The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms can vary greatly between patients. The study aims to describe the Swedish cohort's self-rated quality of life and levels of disease-related symptoms.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

Systemic Mastocytosis (SM) is a rare and complex disease caused by accumulation of mast cells leading to release of mediator substances (e.g., cytokines, prostaglandins, histamine and tryptase). The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms vary between patients and can include e.g., allergic reactions with anaphylaxis, rashes, osteoporoses, cognitive difficulties, fatigue, depression, anxiety, nausea, vomiting, stomach pains and diarrhea. In this cross-sectional observational study, the aim is to include the Swedish cohort of persons diagnosed with SM to gather a wide range of information on self-rated health-related quality of life, gastrointestinal symptoms, pain, anxiety, depression and self-care.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis
Anticipated Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Nov 15, 2028

Arms and Interventions

Arm Intervention/Treatment
Swedish cohort of persons with Systemic Mastocytosis

We aim to include all individuals with a diagnosis of SM in Sweden, by identification via either one the two centers of excellence of mastocytosis or by a regional representative for the mastocytosis group in Sweden.

Other: No intervention
This is a cross-sectional observational study, no intervention will be implemented or exposure studied. Data for outcomes of interest will be collected via questionnaires

Outcome Measures

Primary Outcome Measures

  1. EORTC QLQ C-30 [Day 1]

    EORTC QLQ C-30 measures health related quality of life rated by individuals with malignancies and the general population

  2. The Mastocytosis Quality of Life Questionnaire (MC-QoL) [Day 1]

    The Mastocytosis Quality of Life Questionnaire (MC-QoL), measures disease-specific quality of life items, has scores from 0 to 100, where higher scores indicate higher health-related quality-of-life impairment

  3. The Hospital Anxiety and Depression Scale (HADS) [Day 1]

    The Hospital Anxiety and Depression Scale (HADS), 14 items, measures anxiety and depression.

  4. The Gastrointestinal Symptom Rating Scale (GSRS) [Day 1]

    The Gastrointestinal Symptom Rating Scale (GSRS), 15 items. This instrument measures gastrointestinal symptoms in individuals with irritable bowel syndrome, gastric or duodenal ulcers and dyspepsia

  5. The Visceral Sensitivity Index (VSI) [Day 1]

    The Visceral Sensitivity Index (VSI), 15 items, measures psychosocial consequences and worries of gastrointestinal symptoms

  6. The Brief Pain Inventory - Short form (BPI-SF) [day 1]

    The Brief Pain Inventory - Short form (BPI-SF), 9 items, yields a rating of levels of pain during a 24-hour period, and a description of the nature of that pain. The instrument also contains items on the impact (if any) of the pain of daily life

  7. The Brunnsviken Brief Quality of life scale (BBQ) [Day 1]

    The Brunnsviken Brief Quality of life scale (BBQ), 12 items. The scale measures subjective quality of life

  8. Self Care of Chronic Illness Inventory [Day 1]

    Self Care of Chronic Illness Inventory, 29 items, measures self-care behaviors in persons with chronic illnesses

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Swedish-speaking individuals aged 18 years or older and diagnosed with indolent systemic mastocytosis (ISM) or advanced systemic mastocytosis (AdvSM), verified by a bone marrow biopsy
Exclusion Criteria:

  • An assessment by the treating physician that the individual has a cognitive impairment making participation impossible

  • The patient has undergone an allogeneic stem cell transplant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska Institutet Stockholm Sweden
2 Uppsala University Uppsala Sweden

Sponsors and Collaborators

  • Uppsala University
  • Karolinska Institutet

Investigators

  • Principal Investigator: Mariann Hedström, PhD, Uppsala University, Department of Public Health and Caring Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Uppsala University
ClinicalTrials.gov Identifier:
NCT06065007
Other Study ID Numbers:
  • SMQoL230918
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Mastocytosis
Mastocytosis, Systemic

Study Results

No Results Posted as of Oct 3, 2023