Acupuncture Intervention for AYA With Cancer

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Palliative Care

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03516799

17-014621

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 13 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Acupuncture (ACU) Group

Experimental group

Description:

The group of participants who opt in to acupuncture

Treatment:

Other: Acupuncture

Treatment-as-Usual (TAU) Group

No Intervention group

Description:

The group of participants who enroll in the study but opt out of acupuncture (treatment-as-usual)