Clinical trial NCT03516799: Acupuncture Intervention for AYA With Cancer
Official title: A Pilot Study of Acupuncture for Pain Management for AYA With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: pain management of adolescent and young adults with cancer
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 55
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized trial across four time points at one study site
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of use of Acupuncture for pain management of AYA and associates
timeFrame: 15 weeks
measure: Number of acupuncture sessions completed
timeFrame: 15 weeks
measure: Number of participant-reported barriers to participating in acupuncture sessions for AYA who opt in
timeFrame: 15 weeks
measure: Incidence of patient-reported adverse events of AYA who opt in to acupuncture relative to those who opt out
timeFrame: 15 weeks
Secondary outcomes:
measure: Acupuncture as a pain management tool
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Lisa Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References: