Acupuncture Intervention for AYA With Cancer

NCT03516799 | Completed

• 1 other identifier: 17-014621
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care

Keywords

pain management of adolescent and young adults with cancer

Outcome Measures

Primary Outcomes (4)

• 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?")

  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.

  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?")

  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.

  15 weeks

Secondary Outcomes (1)

• Acupuncture as a pain management tool

  15 weeks

Study Arms (2)

Acupuncture (ACU) Group

EXPERIMENTAL

The group of participants who opt in to acupuncture

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)

Interventions

Acupuncture 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).

Acupuncture (ACU) Group

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Cognitive impairments that would limit the parent/guardian's ability to complete measures

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lisa Schwartz, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized trial across four time points at one study site

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: May 4, 2018
• Study Start: August 13, 2018
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)