A Study of Interviews to Evaluate the Content Validity of Patient- Reported Outcomes for Use in Myelodysplastic Syndromes (MDS)


About this study

The primary objective of this study is to generate evidence for the content validity of the Functional Assessment of Cancer Therapy - Anemia (FACT-An) and the Quality of Life in Myelodysplasia Scale (QUALMS) for use in an MDS population. Specifically, the study aims to gain an understanding of the experience of patients with MDS, including the key symptoms and impacts, as well as assess the patient understanding and relevance of the FACT-An and QUALMS for use in patients with MDS such that they may be used as trial endpoints.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

  1. Male or female ≥18 years of age
  2. Diagnosis of MDS according to World Health Organisation (WHO) criteria confirmed by bone marrow aspirate and biopsy
  3. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk MDS
  4. Red Blood Cell (RBC) transfusion dependent (i.e. requiring at least 4 units during an 8-week period)
  5. Has MDS that is relapsed/refractory to erythropoietic stimulating agent (ESA) treatment
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 2
  7. Able to attend and participate in a 90 minute interview. Must be literate in US-English and verbally fluent in US-English

Exclusion Criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

  1. Subject has received an investigational drug or used an invasive investigational medical device within 30 days prior to screening or is currently enrolled in an investigational study;
  2. Prior history of hematopoietic stem cell transplant;
  3. Diagnosed or treated for malignancy other than MDS;
  4. Significant difficulty hearing, reading or speaking;
  5. Has an uncontrolled psychiatric condition (e.g., schizophrenia, bipolar disorder) or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study or likely to have difficulty participating in a 90 minute interview;
  6. Has severe physical, neurological or cognitive deficits that might affect their ability to participate in an interview about their experience of MDS and completion of two questionnaires.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mrinal Patnaik, M.B.B.S.

Closed for enrollment

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