Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant · Source last updated 2024-02-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
units on a scale
Interval / dispersion
Full Range
Time frame
EORTC QLQ-HDC29 questionnaire will be collected after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) pre stem cell infusion (HSCT), and 100 (± 14) days post stem cell infusion (HSCT).
What was measured
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire High Dose Chemotherapy (EORTC QLQ-HDC29) is a treatment-specific quality of life questionnaire that addresses treatment specific side effects as well as emotional, social, and family issues for patients treated with high dose regimens and HCT. The QLQ-HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 single-items; all items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome with the exception of question 47 and 52 being the a higher score resulting in a better outcome and lower score a worse outcome.
Analysis population: The QLQ-HDC29 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 14 subjects submitted EORTC QLQ-HDC29 at pre-HCST and 10 subjects post-HSCT. For Arm B (induction chemo) 13 subjects submitted QLQ-HDC29 at pre-HSCT and 10 subjects post-HSCT. Scores for each question and timepoints were averaged to obtain mean. However, there are some questions were subjects noted N/A and these answered were subtracted from the number analyzed.
Groups in this outcome
Arm A (Decitabine or Azacitidine)
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
Arm B (Induction-like Chemotherapy Regimen)
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
25
Arm B (Induction-like Chemotherapy Regimen)
25
Reported measurements
QLQ-HDC 29 Pre-HSCT 31. Have you had soreness in your mouth?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.36
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.08
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 31. Have you had soreness in your mouth?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.2
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.0
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 32. Have you had a dry mouth?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.36
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.62
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 32. Have you had a dry mouth?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.0
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.7
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 33. Have you had trouble swallowing?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.07
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.15
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 33. Have you had trouble swallowing?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.2
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.3
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 34. Did food and drink taste different from usual?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.57
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.92
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 34. Did food and drink taste different from usual?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.9
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.2
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 35. Have you had abdominal pains or cramps?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.21
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.38
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 35. Have you had abdominal pains or cramps?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.3
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.6
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 36. Have you had skin problems?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.71
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.38
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 36. Have you had skin problems?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.6
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.5
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 37. Have you been upset by how the treatment has affected your hair?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.43
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.38
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 37. Have you been upset by how the treatment has affected your hair?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.0
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.7
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 38. Have you worried about your weight being too low?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.5
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.62
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 38. Have you worried about your weight being too low?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.6
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.2
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 39. Have you had fevers or chills?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.43
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.46
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 39. Have you had fevers or chills?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.3
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 40. Did you urinate frequently?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.29
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.0
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 40. Did you urinate frequently?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.1
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.4
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 41. Have you had aches or pains in your bones?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.79
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.46
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 41. Have you had aches or pains in your bones?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.7
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.4
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 42. Have you found it difficult to finish things you started?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
25
Arm B (Induction-like Chemotherapy Regimen)
25
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.64
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.46
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 42. Have you found it difficult to finish things you started?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.6
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.3
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 43. Did you worry about the results of examinations and tests?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.92
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.66
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 43. Did you worry about the results of examinations and tests?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.7
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.7
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 44. Have you had trouble coping with the hospital stay?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
5
Arm B (Induction-like Chemotherapy Regimen)
6
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.6
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.5
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 44. Have you had trouble coping with the hospital stay?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
2
Arm B (Induction-like Chemotherapy Regimen)
3
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.0
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.0
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 45. Has the isolation in the hospital troubled you?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
3
Arm B (Induction-like Chemotherapy Regimen)
6
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.66
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.66
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 45. Has the isolation in the hospital troubled you?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
2
Arm B (Induction-like Chemotherapy Regimen)
3
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.0
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.0
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 46. Have you worried that the blood counts may not recover?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
3
Arm B (Induction-like Chemotherapy Regimen)
6
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.0
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.83
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 46. Have you worried that the blood counts may not recover?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
2
Arm B (Induction-like Chemotherapy Regimen)
3
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.5
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
3.33
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 47. How satisfied were you with the preparation for your treatment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
3
Arm B (Induction-like Chemotherapy Regimen)
6
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.33
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.83
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 47. How satisfied were you with the preparation for your treatment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
2
Arm B (Induction-like Chemotherapy Regimen)
2
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.5
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.5
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT 48. Have you felt isolated from those close to you (family, friends)?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.77
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.77
Not reported
1
4
Not reported
QLQ-HDC 29 Post-HSCT 48. Have you felt isolated from those close to you (family, friends)?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.7
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.6
Not reported
1
4
Not reported
QLQ-HDC 29 Pre-HSCT49.Have you been concerned about disruption to your family life due to treatment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.92
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.23
Not reported
1
4
Not reported
QLQ-HDC29Post HSCT 49.Have you been concerned about disruption to your family life due to treatment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.5
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.22
Not reported
1
4
Not reported
QLQ-HDC29 Pre HSCT 50. How distressing do you think your illness/treatment has been to those close?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.62
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.69
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 50. How distressing do you think your illness/treatment has been to those close?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.6
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.5
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 51. Have you felt a need to keep fears/concerns from family or friends?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
14
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.62
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.84
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 51. Have you felt a need to keep fears/concerns from family or friends?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.8
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.2
Not reported
1
4
Not reported
Pre-HSCT 52.Has your experience helped u distinguish between important/non-important things in life?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
12
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.83
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.54
Not reported
1
4
Not reported
PostHSCT 52.Has your experience helped u distinguish between important/non-important things in life?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.1
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
3.1
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 53. Were you worried about your health in the future?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
13
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.23
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.46
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 53. Were you worried about your health in the future?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.5
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.5
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 54. Have you felt physically less attractive due to illness/treatment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
13
Arm B (Induction-like Chemotherapy Regimen)
13
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.0
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.92
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 54. Have you felt physically less attractive due to illness/treatment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
10
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.4
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.1
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 55. Have you been concerned about your ability to have children?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
4
Arm B (Induction-like Chemotherapy Regimen)
4
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.75
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.25
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 55. Have you been concerned about your ability to have children?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
3
Arm B (Induction-like Chemotherapy Regimen)
1
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.33
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 56. Did having to take your drugs regularly interfere with your daily life?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
7
Arm B (Induction-like Chemotherapy Regimen)
9
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.28
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
1.88
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 56. Did having to take your drugs regularly interfere with your daily life?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
9
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
1.9
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.11
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 57. Have you been watching yourself closely for any new symptoms?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
6
Arm B (Induction-like Chemotherapy Regimen)
9
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.66
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.77
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 57. Have you been watching yourself closely for any new symptoms?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
9
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
3.3
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
3.66
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 58. Have you felt less interest in sex?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
6
Arm B (Induction-like Chemotherapy Regimen)
9
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.33
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.55
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 58. Have you felt less interest in sex?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
8
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.50
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.25
Not reported
1
4
Not reported
QLQ-HDC29 Pre-HSCT 59. Have you felt less sexual enjoyment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
6
Arm B (Induction-like Chemotherapy Regimen)
9
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.16
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.66
Not reported
1
4
Not reported
QLQ-HDC29 Post-HSCT 59. Have you felt less sexual enjoyment?
Analysis denominator · Participants
Group
Source count
Arm A (Decitabine or Azacitidine)
10
Arm B (Induction-like Chemotherapy Regimen)
8
Values in units on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Decitabine or Azacitidine)
2.6
Not reported
1
4
Not reported
Arm B (Induction-like Chemotherapy Regimen)
2.25
Not reported
1
4
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.36
group Id
OG001
lower Limit
1
upper Limit
4
value
1.08
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
QLQ-HDC 29 Pre-HSCT 31. Have you had soreness in your mouth?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.2
group Id
OG001
lower Limit
1
upper Limit
4
value
1.0
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
QLQ-HDC 29 Post-HSCT 31. Have you had soreness in your mouth?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.36
group Id
OG001
lower Limit
1
upper Limit
4
value
1.62
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
QLQ-HDC 29 Pre-HSCT 32. Have you had a dry mouth?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
2.0
group Id
OG001
lower Limit
1
upper Limit
4
value
1.7
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
QLQ-HDC 29 Post-HSCT 32. Have you had a dry mouth?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.07
group Id
OG001
lower Limit
1
upper Limit
4
value
1.15
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
QLQ-HDC 29 Pre-HSCT 33. Have you had trouble swallowing?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.2
group Id
OG001
lower Limit
1
upper Limit
4
value
1.3
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
QLQ-HDC 29 Post-HSCT 33. Have you had trouble swallowing?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.57
group Id
OG001
lower Limit
1
upper Limit
4
value
1.92
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
QLQ-HDC 29 Pre-HSCT 34. Did food and drink taste different from usual?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.9
group Id
OG001
lower Limit
1
upper Limit
4
value
2.2
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
QLQ-HDC 29 Post-HSCT 34. Did food and drink taste different from usual?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.21
group Id
OG001
lower Limit
1
upper Limit
4
value
1.38
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
QLQ-HDC 29 Pre-HSCT 35. Have you had abdominal pains or cramps?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.3
group Id
OG001
lower Limit
1
upper Limit
4
value
1.6
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
QLQ-HDC 29 Post-HSCT 35. Have you had abdominal pains or cramps?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.71
group Id
OG001
lower Limit
1
upper Limit
4
value
1.38
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
QLQ-HDC 29 Pre-HSCT 36. Have you had skin problems?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.6
group Id
OG001
lower Limit
1
upper Limit
4
value
1.5
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
QLQ-HDC 29 Post-HSCT 36. Have you had skin problems?
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
25
units
Participants
description
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire High Dose Chemotherapy (EORTC QLQ-HDC29) is a treatment-specific quality of life questionnaire that addresses treatment specific side effects as well as emotional, social, and family issues for patients treated with high dose regimens and HCT. The QLQ-HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 single-items; all items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome with the exception of question 47 and 52 being the a higher score resulting in a better outcome and lower score a worse outcome.
dispersion Type
Full Range
groups
description
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
id
OG000
title
Arm A (Decitabine or Azacitidine)
description
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
id
OG001
title
Arm B (Induction-like Chemotherapy Regimen)
param Type
MEAN
population Description
The QLQ-HDC29 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 14 subjects submitted EORTC QLQ-HDC29 at pre-HCST and 10 subjects post-HSCT. For Arm B (induction chemo) 13 subjects submitted QLQ-HDC29 at pre-HSCT and 10 subjects post-HSCT. Scores for each question and timepoints were averaged to obtain mean. However, there are some questions were subjects noted N/A and these answered were subtracted from the number analyzed.
reporting Status
POSTED
time Frame
EORTC QLQ-HDC29 questionnaire will be collected after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) pre stem cell infusion (HSCT), and 100 (± 14) days post stem cell infusion (HSCT).
title
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
Triangle