Sickle Cell DiseaseNCT01639950
Validating Pain Scales in Children and Young Adults
An observational study of Sickle Cell Disease and Solid Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Assessing pain levels is important to improve treatments for different illnesses. Most pain rating scales are used to determine pain levels in adults. Pain is also a common symptom among children who have cancer. Those who have genetic conditions that may lead to cancer may also have pain symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Solid Tumor, Leukemia
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2012to 28 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Children, adolescents, and young adults ages 6 to 25 years with chronic pain related to cancer, Neurofibromas type 1 (NF1), genetic tumor predisposition syndromes (GTPS), a solid tumor (including but not limited to sarcoma, neuroblastoma, or melanoma), or leukemia and their parent(s) or guardians. (COMPLETED) Adults >/= 18 years of age with cancer, NF1, Sickle Cell Disease (SCD)
Who may be able to join
None listed.
Who cannot join
- Participants may be excluded from this study if in the judgment of the Principal or Associate Investigator, the subject is too ill, or subject s cognitive ability would compromise their ability to participate in study related procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Validation of the English Version of the Pain Interference Index and the Pain Rating Scale in Children, Adolescents, and Adults With Chronic Illness and Their Parents
Background:
- Assessing pain levels is important to improve treatments for different illnesses. Most pain rating scales are used to determine pain levels in adults. Pain is also a common symptom among children who have cancer. Those who have genetic conditions that may lead to cancer may also have pain symptoms. However, the pain scales used for adults have not been fully tested in children and young adults. As a result, they may not be as accurate. Researchers want to test pain rating scales in children and young adults who have cancer and genetic conditions that can lead to cancer.
Read more
Objectives:
- To study the effectiveness of pain rating scales given to children and adults with Sickle Cell Disease (SCD),cancer, and related genetic conditions.
Eligibility:
- Adults 18 and 34 years of age and older who have SCD, cancer, or other genetic conditions that can lead to cancer.
Design:
- Participants with SCD, cancer or related genetic conditions will fill out four questionnaires. These questionnaires will ask about pain levels and how much pain interferes with daily life.
- Pain treatments will not be provided as part of this study.
Read the detailed description
Background:
Pain is a common symptom among children with a variety of medical illnesses. Currently, a number of rating scales are used to assess pain interference and pain severity in adults. However, relatively few measures assessing these variables have been validated for use with children and adolescents, and existing tools have limitations.
Objectives:
The primary objective is to validate the self-report and parent versions of the Pain Interference Index (PII) and the Pain Rating Scale (PRS) by comparison with previously validated measures of pain interference (Modified Brief Pain Inventory) and pain severity (Faces Pain Scale - Revised) in the following populations:
-Children, adolescents, and young adults ages 8 to 25 years with chronic pain related to cancer, Neurofibromas type 1 (NF1), genetic tumor predisposition syndromes (GTPS), a solid tumor (including but not limited to sarcoma, neuroblastoma, or melanoma), or
leukemia and their parent(s) or guardians. (COMPLETED)
Adults > =18 years of age with cancer, NF1, Sickle Cell Disease (SCD)
Eligibility:
- >= 18 years of age
- Diagnosis of cancer, NF1, SCD
- Enrolled on a clinical trial or natural history study at the NIH Clinical Center
Design:
- Eligible participants will be asked to respond one time to the PII and the PRS, as well as the Modified Brief Pain Inventory and Faces Pain Scale - reviewed during a scheduled clinic visit for their primary protocol, over video conferencing, or while inpatient.
- Demographic (gender and age, parent gender (if applicable) and medical (diagnosis, date of diagnosis, pain medication) data will be collected from review of the participants medical record.
- A subset of evaluable participants with SCD will be asked to repeat the PII after approximately 1 month to assess test-retest reliability in this tool.
- Parents of pediatric participants were asked to complete the Parent version of the PII and the Parent PRS. Correlations between patient participant and parent participant questionnaire results for participants with solid tumor, NF1, GTPS, and leukemia will be correlated to establish validity and reliability of the PII and PRS. (COMPLETE)
- Also, results from mother and father reports will be correlated to assess inter-rater reliability. (COMPLETE)
-Data from 12 participants ages 6 and 7 years was collected to determine the feasibility of the forms in this younger age group. (COMPLETE)
- Conditions
- Sickle Cell Disease, Solid Tumor, Leukemia, Neurofibromatosis
- Keywords
- Self-Report, Survey Scale, Validate, Pain Severity, Reliability, Natural History
- Medical subject headings
- Anemia, Sickle Cell, Leukemia, Neurofibromatoses, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults Group 1 | Adults patients with cancer or neurofibromatosis 1 (NF1) | |
| Adults Group 2 | Adults with sickle cell disease (SCD) | |
| Children | Children with with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. -closed | |
| Parents | Parents of children with with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. -closed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability
To validate the Pain Interference Index and the Pain Rating Scale by comparison with previously validated measures
Measured: One time
Secondary outcomes (3)
Validation
To establish the reliability (internal consistency and inter-rater) of the PII and PRS
Measured: One month
Feasability
To establish normative data for the PII and PRS.
Measured: One time
Feasability
To gather preliminary data on the feasibility of using the PII and PRS with children ages 6 and 7 years
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study start6 Aug 2012
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Staci M Peron, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639950
- Sponsor's protocol ID
- 120160
- Other IDs
- 12-C-0160
- Status last verified
- Jun 2024
- First submitted
- 11 Jul 2012
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Fayers PM, Hjermstad MJ, Klepstad P, Loge JH, Caraceni A, Hanks GW, Borchgrevink P, Kaasa S; European Palliative Care Research Collaborative (EPCRC). The dimensionality of pain: palliative care and chronic pain patients differ in their reports of pain intensity and pain interference. Pain. 2011 Jul;152(7):1608-1620. doi: 10.1016/j.pain.2011.02.052. Epub 2011 Apr 1.
PubMed 21458921Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
PubMed 21621130Engel JM, Jensen MP, Ciol MA, Bolen GM. The development and preliminary validation of the pediatric survey of pain attitudes. Am J Phys Med Rehabil. 2012 Feb;91(2):114-21. doi: 10.1097/PHM.0b013e318238a074.
PubMed 22019973
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the English Version of the Pain Interference Index and the Pain Rating Scale in Children, Adolescents, and Adults With Chronic Illness and Their Parents
- ClinicalTrials.gov ID
- NCT01639950
- Acronym / sponsor ID
- 120160
- Conditions
- Sickle Cell Disease, Solid Tumor, Leukemia, Neurofibromatosis
- Keywords
- Self-Report, Survey Scale, Validate, Pain Severity, Reliability, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Aug 2012 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Assessing pain levels is important to improve treatments for different illnesses. Most pain rating scales are used to determine pain levels in adults. Pain is also a common symptom among children who have cancer. Those who have genetic conditions that may lead to cancer may also have pain symptoms. However, the pain scales used for adults have not been fully tested in children and young adults. As a result, they may not be as accurate. Researchers want to test pain rating scales in children and young adults who have cancer and genetic conditions that can lead to cancer.
Objectives:
- To study the effectiveness of pain rating scales given to children and adults with Sickle Cell Disease (SCD),cancer, and related genetic conditions.
Eligibility:
- Adults 18 and 34 years of age and older who have SCD, cancer, or other genetic conditions that can lead to cancer.
Design:
- Participants with SCD, cancer or related genetic conditions will fill out four questionnaires. These questionnaires will ask about pain levels and how much pain interferes with daily life.
- Pain treatments will not be provided as part of this study.
Detailed description
Background:
Pain is a common symptom among children with a variety of medical illnesses. Currently, a number of rating scales are used to assess pain interference and pain severity in adults. However, relatively few measures assessing these variables have been validated for use with children and adolescents, and existing tools have limitations.
Objectives:
The primary objective is to validate the self-report and parent versions of the Pain Interference Index (PII) and the Pain Rating Scale (PRS) by comparison with previously validated measures of pain interference (Modified Brief Pain Inventory) and pain severity (Faces Pain Scale - Revised) in the following populations:
-Children, adolescents, and young adults ages 8 to 25 years with chronic pain related to cancer, Neurofibromas type 1 (NF1), genetic tumor predisposition syndromes (GTPS), a solid tumor (including but not limited to sarcoma, neuroblastoma, or melanoma), or
leukemia and their parent(s) or guardians. (COMPLETED)
Adults > =18 years of age with cancer, NF1, Sickle Cell Disease (SCD)
Eligibility:
- >= 18 years of age
- Diagnosis of cancer, NF1, SCD
- Enrolled on a clinical trial or natural history study at the NIH Clinical Center
Design:
- Eligible participants will be asked to respond one time to the PII and the PRS, as well as the Modified Brief Pain Inventory and Faces Pain Scale - reviewed during a scheduled clinic visit for their primary protocol, over video conferencing, or while inpatient.
- Demographic (gender and age, parent gender (if applicable) and medical (diagnosis, date of diagnosis, pain medication) data will be collected from review of the participants medical record.
- A subset of evaluable participants with SCD will be asked to repeat the PII after approximately 1 month to assess test-retest reliability in this tool.
- Parents of pediatric participants were asked to complete the Parent version of the PII and the Parent PRS. Correlations between patient participant and parent participant questionnaire results for participants with solid tumor, NF1, GTPS, and leukemia will be correlated to establish validity and reliability of the PII and PRS. (COMPLETE)
- Also, results from mother and father reports will be correlated to assess inter-rater reliability. (COMPLETE)
-Data from 12 participants ages 6 and 7 years was collected to determine the feasibility of the forms in this younger age group. (COMPLETE)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adults Group 1 | – | –Adults patients with cancer or neurofibromatosis 1 (NF1) |
| Adults Group 2 | – | –Adults with sickle cell disease (SCD) |
| Children | – | –Children with with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. -closed |
| Parents | – | –Parents of children with with neurofibromatosis 1 (NF1), genetic tumor predisposition syndromes (GTPS), malignant solid tumor, or leukemia. -closed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Children, adolescents, and young adults ages 6 to 25 years with chronic pain related to cancer, Neurofibromas type 1 (NF1), genetic tumor predisposition syndromes (GTPS), a solid tumor (including but not limited to sarcoma, neuroblastoma, or melanoma), or leukemia and their parent(s) or guardians. (COMPLETED) Adults >/= 18 years of age with cancer, NF1, Sickle Cell Disease (SCD)
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Participants may be excluded from this study if in the judgment of the Principal or Associate Investigator, the subject is too ill, or subject s cognitive ability would compromise their ability to participate in study related procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasability
Time frame: One time
To validate the Pain Interference Index and the Pain Rating Scale by comparison with previously validated measures
3 secondary outcomes
Validation
Time frame: One month
Feasability
Time frame: One time
Feasability
Time frame: One time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 21458921Fayers PM, Hjermstad MJ, Klepstad P, Loge JH, Caraceni A, Hanks GW, Borchgrevink P, Kaasa S; European Palliative Care Research Collaborative (EPCRC). The dimensionality of pain: palliative care and chronic pain patients differ in their reports of pain intensity and pain interference. Pain. 2011 Jul;152(7):1608-1620. doi: 10.1016/j.pain.2011.02.052. Epub 2011 Apr 1.
- Background: PubMed 21621130Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
- Background: PubMed 22019973Engel JM, Jensen MP, Ciol MA, Bolen GM. The development and preliminary validation of the pediatric survey of pain attitudes. Am J Phys Med Rehabil. 2012 Feb;91(2):114-21. doi: 10.1097/PHM.0b013e318238a074.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Staci M Peron, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Solid Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability (time frame: One time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01639950, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.