Quality of life and late effects in leukemia survivors
- Conditions
- eukemia+C92.0C92.5C92.6C92.3C93.0C94.0C94.2Acute myeloblastic leukaemia [AML]Acute myelomonocytic leukaemia
- Registration Number
- DRKS00023991
- Lead Sponsor
- Medizinische Klinik IUniversitätsklinikum Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 427
Inclusion Criteria
Patients suffering from acute myeloid leukemia (AML) who were enrolled into the patient registry of the German AML Cooperative Group (AML-CG, DRKS00020816) and/or one of the following interventional trials: AMLCG-1999 (clinicaltrials.gov NCT00266136), AMLCG-2004 (European Leukemia Trial Registry Nr. LN_AMLINT_2004_230), AMLCG-2008 (clinicaltrials.gov NCT01382147).
- Study participants have survived =5 years from initial diagnosis off AML.
Exclusion Criteria
- Current leukemia relapse
- Age <18 years
- Inability to give valid informed consent
- Insufficient german language proficiency which makes the participant unable to answer the study questionnaires
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint of this study is a comparison of quality of life (QoL) and general and health-related life satisfaction (LS) in AML survivors, compared to an age- and sex-matched healthy control cohort. QoL and LS will be measured using the FACT-G and FLZ-A/G questionnaires, respectively. We will use a graph-based sequential testing procedure to control for multiple testing of the co-primary endpoints (Bretz F et al., Stat Med 2009; 28:586).
- Secondary Outcome Measures
Name Time Method - Frequency of clonal hematopoiesis in AML long-term survivors<br>- Medical, psycho-social and demographic factors associated with an increased risk of somatic or psychological health problems in AML survivors<br>- Associations between clonal hematopoiesis and somatic morbidity in AML survivors