Acupuncture Intervention for AYA With Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03516799|
Recruitment Status : Not yet recruiting
First Posted : May 4, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Palliative Care||Other: Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|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|
Experimental: Acupuncture (ACU) Group
The group of participants who opt in to 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)
- 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?")
- 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.
- 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?")
- 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.
- 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.
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
|Contact: Lisa Schwartz, PhDfirstname.lastname@example.org|
|Contact: Bridget O'Hagan, MSemail@example.com|
|Principal Investigator:||Lisa Schwartz, PhD||Children's Hospital of Philadelphia|