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Acupuncture Intervention for AYA With Cancer

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ClinicalTrials.gov Identifier: NCT03516799
Recruitment Status : Not yet recruiting
First Posted : May 4, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Palliative Care Other: Acupuncture Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-randomized trial across four time points at one study site
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Acupuncture for Pain Management for AYA With Cancer
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture (ACU) Group
The group of participants who opt in to acupuncture
Other: 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).

No Intervention: Treatment-as-Usual (TAU) Group
The group of participants who enroll in the study but opt out of acupuncture (treatment-as-usual)



Primary Outcome Measures :
  1. 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?")

  2. 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.

  3. 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?")

  4. 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.


Secondary Outcome Measures :
  1. Acupuncture as a pain management tool [ Time Frame: 15 weeks ]
    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.



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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516799


Contacts
Contact: Lisa Schwartz, PhD 267-426-0355 schwartzl@email.chop.edu
Contact: Bridget O'Hagan, MS 267-426-8383 ohaganb@email.chop.edu

Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Lisa Schwartz, PhD Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03516799     History of Changes
Other Study ID Numbers: 17-014621
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Philadelphia:
pain management of adolescent and young adults with cancer