CancerNCT05594693
Integrative Health Interventions in Symptom Management of Pediatric Patients
An observational study of Cancer and Pediatric Cancer, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Read more about this study
- Who is it for?
- Ages 30 days to 30 years
- Conditions the study is for
- Cancer, Pediatric Cancer
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2022to 26 Feb 2024
- 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 30 days to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients at CHCO include premature infants through young adults. Any of these patients could benefit from integrative treatments. The treatments will only be offered after medical team approval and parental consent. All treatments will be provided by credentialed and licensed providers and will follow CHCO approved policies and procedures.
Who may be able to join
- Any CHCO patient referred for integrative interventions by the Pain Service or the Palliative Care Service
Who cannot join
- Patients who have non-consenting providers or caregivers
- Any patient the medical team feels is inappropriate for the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Childrens Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: QuICK: A Quality of Life Study of Integrative and Complementary Therapies for Kids (An Exploratory Feasibility Study of Data Collection)
As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care.
Read the detailed description
The care of children at the quaternary children's hospital is focused in traditional Western medicine modalities of diagnosis, surgery, and medical treatment with pharmacologic medications. However, integrative health modalities, such as acupuncture, massage, Reiki, nutritional supplements, or oral complementary therapies (such as cannabinoids) have been increasingly discussed by our patients, especially during Palliative Care Consults. As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care. The objective of this project is to examine feasibility, timing, appropriate measures, and provide the basis for future in-depth study of the outcomes of individual integrative symptom management strategies.
Hypotheses:
Children, adolescents, and young adults will be able to complete electronic self-report questionnaires and physical measures before and after integrative interventions, and monthly.
Caregivers will be able to complete electronic proxy questionnaires before and after integrative interventions, and monthly.
Integrative interventions will be associated with changes on the questionnaires and physical measures such as a decrease in frequency, severity, or level of interference with symptoms.
Participants will rate their satisfaction with integrative interventions positively.
- Conditions
- Cancer, Pediatric Cancer
- Being tested
- Questionnaire, Physical Exam
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Electronic self-report questionnaires before and after integrative interventions, and monthly.
Physical ExamOther
Also called Inclinometer
Physical measures before and after integrative interventions, and monthly. Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.).
| Study group | Role | What they receive |
|---|---|---|
| Patients Referred by the Pain Service or Palliative Care Service | Any CHCO patient referred for integrative interventions by the Pain Service or the Palliative Care Service.
Patients at CHCO include premature infants through young adults. Any of these patients could benefit from integrative treatments. The treatments will only be offered after medical team approval and parental consent. All treatments will be provided by credentialed and licensed providers and will follow CHCO approved policies and procedures. Receives: Other: Questionnaire; Other: Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the type of of therapy administered per cohort
The team will determine which therapy will be used when administering the questionnaire
Measured: 12 months
Determine the type of therapy administered per participant
The team will determine which therapy will be used when administering the questionnaire
Measured: 12 months
The mean length of time of intervention per cohort
The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.
Measured: 12 months
The mean length of time of intervention per patient
The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.
Measured: 12 months
Accrual rate based on eligible patients
The accrual rate based on percentage of eligible patients who are approached vs how many sign consent.
Measured: 12 months
Patient satisfaction of integrative intervention
Identify patient satisfaction of integrative intervention by having the patient rate the integrative intervention
Measured: 12 months
Determine level of symptom interference in active treatment using the PRO-CTCAE
The Pediatric Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system is content valid for children ages 7 years and older The 15 core CTCAE terms are abdominal pain, constipation, diarrhea, mucositis, nausea, vomiting, fatigue, pain, anorexia, headache, peripheral sensory neuropathy, anxiety, depression, insomnia, and cough. The measure uses a 4-point Likert-type scale to assess frequency, severity, and level of interference.
Measured: 12 months
Determine Patient QOL using Pediatric PROMIS
Determine patient Quality of Life (QOL) using Pediatric Patient Reported Outcomes Measurement Information System (PROMIS).
Acceptable item and scale reliability have been documented. Items are scored from 0 (never) to 4 (almost always) for symptom interference and psychological measures, and from 0 (with no trouble) to 4 (not able to do) for performance measures. All domains use a 5-point Likert scale and are reported as individual domain scores.
Measured: 12 months
Determine Emotional Pain Using the Faces Scale
The Faces Scale has been used for evaluating emotional responses to pain on children 3-17 years old. It is a one page form with nine faces in order of happy to upset. Numerical values are given to each face as determined by childrens' perspectives for an affective value by asking 200 children to directly scale the feelings depicted by the faces.
Measured: 12 months
Determine Patient Satisfaction Using a 5-point Likert Scale
A satisfaction questionnaire will be included as the final question in the post-intervention tool and in the three-month follow up tool. Satisfaction with each type of intervention received will be measured by a five-point Likert scale.
Measured: 12 months
Determine Number of Patients with Active Heart Rate Monitoring During Intervention
Collect data on the percentage of patients who have active heart rate monitoring during the intervention to give a general of the possibility of gathering vital sign data in the future.
Measured: 12 months
Determine Patient Posture Using an Inclinometer
Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.). The patient will assume a relaxed standing position with feet together. The evaluator palpates the spinous processes of thoracic vertebrae (T) 1, T2, T12, and lumbar vertebrae (L)1 for inclinometer placement. First, the caudal inclinometer is placed on T12 and L1, and then the cranial inclinometer is placed at T1 and T2. The angle on each of the inclinometers is then read and recorded. The thoracic kyphosis angle is calculated by the sum of the two inclinometer readings.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start16 Jun 2022
- Primary completion25 Oct 2022
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- OHSU Knight Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Jennifer Raybin, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594693
- Sponsor's protocol ID
- 21-3665.cc
- Other IDs
- NCI-2022-05216
- Status last verified
- Jan 2026
- First submitted
- 30 Aug 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raybin JL, Montgomery K, Janosy N, Mist S, Franklin H, Dieckmann NF, Hendricks-Ferguson VL, Jankowski CM. Study of Complementary and Integrative Interventions in Pediatric Patients With Serious Illness. J Pain Symptom Manage. 2025 May;69(5):515-526. doi: 10.1016/j.jpainsymman.2025.02.013. Epub 2025 Feb 17.
PubMed 39971211
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuICK: A Quality of Life Study of Integrative and Complementary Therapies for Kids (An Exploratory Feasibility Study of Data Collection)
- ClinicalTrials.gov ID
- NCT05594693
- Acronym / sponsor ID
- 21-3665.cc
- Conditions
- Cancer, Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- OHSU Knight Cancer Institute
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 26 Oct 2022 (actual)
- 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.
As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care.
Detailed description
The care of children at the quaternary children's hospital is focused in traditional Western medicine modalities of diagnosis, surgery, and medical treatment with pharmacologic medications. However, integrative health modalities, such as acupuncture, massage, Reiki, nutritional supplements, or oral complementary therapies (such as cannabinoids) have been increasingly discussed by our patients, especially during Palliative Care Consults. As healthcare demands high-quality cost-effective care and patients seek self-management strategies, integrative medicine has become more of an interest to patients, physicians, and administrators. The NIH has a dedicated center (National Center for Complementary and Integrative Health) for integrative therapies. Additionally, these treatments must meet evidence-based criteria for efficacy to be considered for reimbursement and in order for clinical settings to integrate them into the standard of care. The objective of this project is to examine feasibility, timing, appropriate measures, and provide the basis for future in-depth study of the outcomes of individual integrative symptom management strategies.
Hypotheses:
Children, adolescents, and young adults will be able to complete electronic self-report questionnaires and physical measures before and after integrative interventions, and monthly.
Caregivers will be able to complete electronic proxy questionnaires before and after integrative interventions, and monthly.
Integrative interventions will be associated with changes on the questionnaires and physical measures such as a decrease in frequency, severity, or level of interference with symptoms.
Participants will rate their satisfaction with integrative interventions positively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Referred by the Pain Service or Palliative Care Service | – | Other: Questionnaire, Other: Physical ExamAny CHCO patient referred for integrative interventions by the Pain Service or the Palliative Care Service. Patients at CHCO include premature infants through young adults. Any of these patients could benefit from integrative treatments. The treatments will only be offered after medical team approval and parental consent. All treatments will be provided by credentialed and licensed providers and will follow CHCO approved policies and procedures. |
Who may qualify
- Ages
- 30 days to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients at CHCO include premature infants through young adults. Any of these patients could benefit from integrative treatments. The treatments will only be offered after medical team approval and parental consent. All treatments will be provided by credentialed and licensed providers and will follow CHCO approved policies and procedures.
Key inclusion criteria (1 listed)
- Any CHCO patient referred for integrative interventions by the Pain Service or the Palliative Care Service
Key exclusion criteria (2 listed)
- Patients who have non-consenting providers or caregivers
- Any patient the medical team feels is inappropriate for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireElectronic self-report questionnaires before and after integrative interventions, and monthly. | Other | Patients Referred by the Pain Service or Palliative Care Service |
| Physical ExamAlso: InclinometerPhysical measures before and after integrative interventions, and monthly. Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.). | Other | Patients Referred by the Pain Service or Palliative Care Service |
Primary outcome
Determine the type of of therapy administered per cohort
Time frame: 12 months
The team will determine which therapy will be used when administering the questionnaire
Determine the type of therapy administered per participant
Time frame: 12 months
The team will determine which therapy will be used when administering the questionnaire
The mean length of time of intervention per cohort
Time frame: 12 months
The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.
The mean length of time of intervention per patient
Time frame: 12 months
The team will identify which therapy will be used when administering the questionnaire. The type of therapy will determine the length of time.
Accrual rate based on eligible patients
Time frame: 12 months
The accrual rate based on percentage of eligible patients who are approached vs how many sign consent.
Patient satisfaction of integrative intervention
Time frame: 12 months
Identify patient satisfaction of integrative intervention by having the patient rate the integrative intervention
Determine level of symptom interference in active treatment using the PRO-CTCAE
Time frame: 12 months
The Pediatric Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system is content valid for children ages 7 years and older The 15 core CTCAE terms are abdominal pain, constipation, diarrhea, mucositis, nausea, vomiting, fatigue, pain, anorexia, headache, peripheral sensory neuropathy, anxiety, depression, insomnia, and cough. The measure uses a 4-point Likert-type scale to assess frequency, severity, and level of interference.
Determine Patient QOL using Pediatric PROMIS
Time frame: 12 months
Determine patient Quality of Life (QOL) using Pediatric Patient Reported Outcomes Measurement Information System (PROMIS). Acceptable item and scale reliability have been documented. Items are scored from 0 (never) to 4 (almost always) for symptom interference and psychological measures, and from 0 (with no trouble) to 4 (not able to do) for performance measures. All domains use a 5-point Likert scale and are reported as individual domain scores.
Determine Emotional Pain Using the Faces Scale
Time frame: 12 months
The Faces Scale has been used for evaluating emotional responses to pain on children 3-17 years old. It is a one page form with nine faces in order of happy to upset. Numerical values are given to each face as determined by childrens' perspectives for an affective value by asking 200 children to directly scale the feelings depicted by the faces.
Determine Patient Satisfaction Using a 5-point Likert Scale
Time frame: 12 months
A satisfaction questionnaire will be included as the final question in the post-intervention tool and in the three-month follow up tool. Satisfaction with each type of intervention received will be measured by a five-point Likert scale.
Determine Number of Patients with Active Heart Rate Monitoring During Intervention
Time frame: 12 months
Collect data on the percentage of patients who have active heart rate monitoring during the intervention to give a general of the possibility of gathering vital sign data in the future.
Determine Patient Posture Using an Inclinometer
Time frame: 12 months
Thoracic kyphosis will be measured with a non-invasive gravity dependent inclinometer (Isomed Inc.). The patient will assume a relaxed standing position with feet together. The evaluator palpates the spinous processes of thoracic vertebrae (T) 1, T2, T12, and lumbar vertebrae (L)1 for inclinometer placement. First, the caudal inclinometer is placed on T12 and L1, and then the cranial inclinometer is placed at T1 and T2. The angle on each of the inclinometers is then read and recorded. The thoracic kyphosis angle is calculated by the sum of the two inclinometer readings.
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 16 Jan 2026.
- Derived from this study: PubMed 39971211Raybin JL, Montgomery K, Janosy N, Mist S, Franklin H, Dieckmann NF, Hendricks-Ferguson VL, Jankowski CM. Study of Complementary and Integrative Interventions in Pediatric Patients With Serious Illness. J Pain Symptom Manage. 2025 May;69(5):515-526. doi: 10.1016/j.jpainsymman.2025.02.013. Epub 2025 Feb 17.
- Individual participant dataSharing planned: No
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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.
Jennifer Raybin principal investigator
OHSU Knight Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Pediatric Cancer, run by University of Colorado, Denver at 3 sites 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 1 inclusion and 2 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Determine the type of of therapy administered per cohort (time frame: 12 months). The study lists 12 primary outcomes in all. 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 NCT05594693, which also lists 1 linked publication.
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 16 Jan 2026.