Palliative CareNCT03516799
Acupuncture Intervention for AYA With Cancer
A study testing Acupuncture in people with Palliative Care, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The aim of the study is to innovatively extend acupuncture research in adult oncology to adolescents and young adults (AYA) by piloting a tailored acupuncture protocol for pain management in AYA in the Children's Hospital of Philadelphia (CHOP's) Center for Integrative Health. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Palliative Care
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 8 Nov 2019
- Phase
- Interventional
- 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 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
AYA Inclusion Criteria:
- Report a pain severity score of ≥ 4 in last 7 days on an 11-point (0-10) numerical rating scale and reports a pain distress score of ≥ 2 on a 5-point numerical rating scale
- Males or females age 13 to 24 years
- On treatment for cancer for at least one month or within two years of completing treatment
- Not expected to be terminal within the next 6 months
- Absence of infection or bleeding disorder
- Physically and medically able to get to the acupuncture clinic
- Able to read and write English
AYA Exclusion Criteria:
- Absence of inclusion criteria above
- Parents'guardians or subjects who, in the opinion of the investigator, may be non-compliant with the study schedules or procedures
- Cognitive impairments that would limit AYA's ability to complete measures or to independently care for health as determined by medical team
Parent/Guardian Inclusion Criteria:
- Be primary parent/guardian of the AYA participant
- Be able to read and write English
Parent/Guardian Exclusion Criteria:
- Cognitive impairments that would limit the parent/guardian's ability to complete measures
- Absence of inclusion criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study of Acupuncture for Pain Management for AYA With Cancer
The aim of the study is to innovatively extend acupuncture research in adult oncology to adolescents and young adults (AYA) by piloting a tailored acupuncture protocol for pain management in AYA in the Children's Hospital of Philadelphia (CHOP's) Center for Integrative Health.
Read the detailed description
Acupuncture is an integrative medicine (IM) with a growing evidence base that is often incorporated into comprehensive pain management in adult oncology. However, it is under-utilized and under-researched in pediatric oncology, especially with adolescents and young adults (AYA). Acupuncture is a promising palliative therapy to manage pain and improve quality of life (QOL) of AYA. AYA are underserved and typically endure more morbidity and longer treatments than younger patients. More than half report at least three debilitating cancer-related symptoms and their QOL is significantly lower compared to norms, with symptoms being the greatest contributor to poor QOL. Not surprisingly, AYA identify pain management as an unmet need, leading a majority of AYA to want information on IM or seek it for treatment. Given the potential benefit of acupuncture for addressing unmet needs of AYA by reducing physical suffering, and the established difficulty with pain management using conventional methods, there is a critical need to establish the efficacy of acupuncture for pain management in AYA. The few studies that have evaluated acupuncture in pediatric oncology, demonstrating it to be safe, accepted, and associated with symptom relief are uncontrolled, retrospective, and/or unprotocolized, and none focus on AYA. To establish the evidence base for acupuncture in AYA oncology, research is needed to determine and test optimal acupuncture protocols.
- Conditions
- Palliative Care
- Being tested
- Acupuncture
- Keywords
- pain management of adolescent and young adults with cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture is a method of Traditional Chinese Medicine that consists of the insertion of thin, sterile, FDA-approved disposable needles on specific acupuncture points (acupoints).
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture (ACU) Group | Experimental | The group of participants who opt in to acupuncture Receives: Other: Acupuncture |
| Treatment-as-Usual (TAU) Group | No intervention | The group of participants who enroll in the study but opt out of acupuncture (treatment-as-usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of use of Acupuncture for pain management of AYA and associates
Number of participants who report satisfaction and intention for future use through a qualitative semi-structured interview. ("How satisfied were you with the number of acupuncture sessions you received over the course of the study?"...."how likely would you be to continue to receive acupuncture in the future?")
Measured: 15 weeks
Number of acupuncture sessions completed
Number of sessions participants complete and time between sessions, which will be logged by research team for feasibility.
Measured: 15 weeks
Number of participant-reported barriers to participating in acupuncture sessions for AYA who opt in
Number of participants who report barriers to participation during qualitative semi-structured interview for feasibility. ("How difficult or inconvenient did you find going to your acupuncture appointment over the course of these past 10 weeks to be?")
Measured: 15 weeks
Incidence of patient-reported adverse events of AYA who opt in to acupuncture relative to those who opt out
Limited report of acupuncture-related side effects which will be logged as patient reported outcomes ("did you experience any adverse events?") post-acupuncture sessions. Treatment-Related Adverse Events as Assessed by CTCAE v4.0, change from baseline in pain scores.
Measured: 15 weeks
Secondary outcomes (1)
Acupuncture as a pain management tool
To determine the preliminary efficacy of acupuncture for pain management of AYA. Compared to AYA who opt out, AYA who receive acupuncture will report, from baseline to post-treatment: reduced severity of pain, improvement in QOL, reduced pain interference, and symptom-related distress through a questionnaire.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start13 Aug 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized trial across four time points at one study site
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Schwartz, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516799
- Sponsor's protocol ID
- 17-014621
- Status last verified
- Dec 2019
- First submitted
- 23 Mar 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Acupuncture for Pain Management for AYA With Cancer
- ClinicalTrials.gov ID
- NCT03516799
- Acronym / sponsor ID
- 17-014621
- Conditions
- Palliative Care
- Keywords
- pain management of adolescent and young adults with cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 4 May 2018 (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.
The aim of the study is to innovatively extend acupuncture research in adult oncology to adolescents and young adults (AYA) by piloting a tailored acupuncture protocol for pain management in AYA in the Children's Hospital of Philadelphia (CHOP's) Center for Integrative Health.
Detailed description
Acupuncture is an integrative medicine (IM) with a growing evidence base that is often incorporated into comprehensive pain management in adult oncology. However, it is under-utilized and under-researched in pediatric oncology, especially with adolescents and young adults (AYA). Acupuncture is a promising palliative therapy to manage pain and improve quality of life (QOL) of AYA. AYA are underserved and typically endure more morbidity and longer treatments than younger patients. More than half report at least three debilitating cancer-related symptoms and their QOL is significantly lower compared to norms, with symptoms being the greatest contributor to poor QOL. Not surprisingly, AYA identify pain management as an unmet need, leading a majority of AYA to want information on IM or seek it for treatment. Given the potential benefit of acupuncture for addressing unmet needs of AYA by reducing physical suffering, and the established difficulty with pain management using conventional methods, there is a critical need to establish the efficacy of acupuncture for pain management in AYA. The few studies that have evaluated acupuncture in pediatric oncology, demonstrating it to be safe, accepted, and associated with symptom relief are uncontrolled, retrospective, and/or unprotocolized, and none focus on AYA. To establish the evidence base for acupuncture in AYA oncology, research is needed to determine and test optimal acupuncture protocols.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized trial across four time points at one study site
| Arm | Type | Receives |
|---|---|---|
| Acupuncture (ACU) Group | Experimental | Other: AcupunctureThe group of participants who opt in to acupuncture |
| Treatment-as-Usual (TAU) Group | No intervention | –The group of participants who enroll in the study but opt out of acupuncture (treatment-as-usual) |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| AcupunctureAcupuncture is a method of Traditional Chinese Medicine that consists of the insertion of thin, sterile, FDA-approved disposable needles on specific acupuncture points (acupoints). | Other | Acupuncture (ACU) Group |
Primary outcome
Acceptability of use of Acupuncture for pain management of AYA and associates
Time frame: 15 weeks
Number of participants who report satisfaction and intention for future use through a qualitative semi-structured interview. ("How satisfied were you with the number of acupuncture sessions you received over the course of the study?"...."how likely would you be to continue to receive acupuncture in the future?")
Number of acupuncture sessions completed
Time frame: 15 weeks
Number of sessions participants complete and time between sessions, which will be logged by research team for feasibility.
Number of participant-reported barriers to participating in acupuncture sessions for AYA who opt in
Time frame: 15 weeks
Number of participants who report barriers to participation during qualitative semi-structured interview for feasibility. ("How difficult or inconvenient did you find going to your acupuncture appointment over the course of these past 10 weeks to be?")
Incidence of patient-reported adverse events of AYA who opt in to acupuncture relative to those who opt out
Time frame: 15 weeks
Limited report of acupuncture-related side effects which will be logged as patient reported outcomes ("did you experience any adverse events?") post-acupuncture sessions. Treatment-Related Adverse Events as Assessed by CTCAE v4.0, change from baseline in pain scores.
1 secondary outcome
Acupuncture as a pain management tool
Time frame: 15 weeks
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 18 Dec 2019.
- 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.
Lisa Schwartz, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Palliative Care, run by Children's Hospital of Philadelphia 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?
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 18 Dec 2019. 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?
Acceptability of use of Acupuncture for pain management of AYA and associates (time frame: 15 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2019.