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Acupuncture Intervention for AYA With Cancer

NCT ID: NCT03516799

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2019-11-08

Brief Summary

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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

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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

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Palliative Care

Keywords

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pain management of adolescent and young adults with cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Non-randomized trial across four time points at one study site
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Acupuncture (ACU) Group

The group of participants who opt in to acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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).

Treatment-as-Usual (TAU) Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

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).

Intervention Type OTHER

Eligibility Criteria

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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

* 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


* Be primary parent/guardian of the AYA participant
* Be able to read and write English

Exclusion Criteria

* Cognitive impairments that would limit the parent/guardian's ability to complete measures
Minimum Eligible Age

13 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Schwartz, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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17-014621

Identifier Type: -

Identifier Source: org_study_id