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NCT04459416 · BASELINE

Baseline characteristics

Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma · Source last updated 2025-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      151
    2. group Id
      BG001
      value
      147
    3. group Id
      BG002
      value
      298
    units
    Participants
groups
  1. description
    Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
    id
    BG000
    title
    Acupuncture Plus Usual Care
  2. description
    Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
    id
    BG001
    title
    Usual Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24.8
          upper Limit
          77.7
          value
          58.4
        2. group Id
          BG001
          lower Limit
          19.2
          upper Limit
          75.3
          value
          58.1
        3. group Id
          BG002
          lower Limit
          19.2
          upper Limit
          77.7
          value
          58.3
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          157
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          276
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          235
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          298
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      151
    2. group Id
      BG001
      value
      147
    3. group Id
      BG002
      value
      298
    units
    Participants
groups
  1. description
    Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
    id
    BG000
    title
    Acupuncture Plus Usual Care
  2. description
    Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
    id
    BG001
    title
    Usual Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24.8
          upper Limit
          77.7
          value
          58.4
        2. group Id
          BG001
          lower Limit
          19.2
          upper Limit
          75.3
          value
          58.1
        3. group Id
          BG002
          lower Limit
          19.2
          upper Limit
          77.7
          value
          58.3
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          157
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          22
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          276
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          17
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          235
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          298
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice