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Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: women with histologically confirmed stage 0, I, II, or III breast cancer > 18 years of old who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy are able to read and speak English with self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month and their average severity rating ≥ 3 (0-10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, sleep disturbance). Exclusion Criteria: Metastatic breast cancer (stage IV) have a bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia) failure to comply with weekly visits to the acupuncture clinic during the interventional phase of the study Psychiatric or medical disorders which would affect study assessments, such as, dementia, Alzheimer's disease, a history of any neurological condition, traumatic brain injury, stroke, and the use of psychotropic medication Breastfeeding, pregnant or are planning get pregnant during the study period

Sites / Locations

  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture group

Usual care group

Arm Description

Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.

Participants will continue to receive their usual care.

Outcomes

Primary Outcome Measures

Acceptability for Treating Multiple Symptoms with Acupuncture
Protocol Acceptability Scale is a 9-item instrument with scores ranging from 0 to 18 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 9 questions, divided the total score for the 9 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating.
The numbers of study participants being recruited and retained (Feasibility)
The numbers of study participants being recruited and retained during the study period will be documented as planned
Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics.
Specific questions will be asked during a face-to-face interview to identify factors favoring or barriers to implementing acupuncture into federally qualified health center oncology clinics among breast cancer survivors and providers.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2022
Last Updated
March 23, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05615753
Brief Title
Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors
Official Title
Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test the feasibility of implementing acupuncture intervention in federally qualified health centers oncology clinics for breast cancer survivors.
Detailed Description
This study has the following specific aims: Aim 1: Test the feasibility and acceptability of implementing a 5-week acupuncture intervention within federally qualified health center oncology clinic to manage multiple symptoms (pain, hot flashes, fatigue, sleep disturbance, depression, anxiety) among breast cancer survivors receiving endocrine therapy. Aim 2: Use a mixed methods approach to identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Participants will continue to receive their usual care.
Intervention Type
Behavioral
Intervention Name(s)
Acupuncture
Intervention Description
All participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location,
Primary Outcome Measure Information:
Title
Acceptability for Treating Multiple Symptoms with Acupuncture
Description
Protocol Acceptability Scale is a 9-item instrument with scores ranging from 0 to 18 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 9 questions, divided the total score for the 9 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating.
Time Frame
At week 6 after finishing the 10th acupuncture treatment
Title
The numbers of study participants being recruited and retained (Feasibility)
Description
The numbers of study participants being recruited and retained during the study period will be documented as planned
Time Frame
: from the activation of the study to the completion of the recruitment, week 12
Title
Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics.
Description
Specific questions will be asked during a face-to-face interview to identify factors favoring or barriers to implementing acupuncture into federally qualified health center oncology clinics among breast cancer survivors and providers.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with histologically confirmed stage 0, I, II, or III breast cancer > 18 years of old who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy are able to read and speak English with self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month and their average severity rating ≥ 3 (0-10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, sleep disturbance). Exclusion Criteria: Metastatic breast cancer (stage IV) have a bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia) failure to comply with weekly visits to the acupuncture clinic during the interventional phase of the study Psychiatric or medical disorders which would affect study assessments, such as, dementia, Alzheimer's disease, a history of any neurological condition, traumatic brain injury, stroke, and the use of psychotropic medication Breastfeeding, pregnant or are planning get pregnant during the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongjin Li, PhD
Phone
3124139845
Email
hongjin@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hongjin Li
Phone
3124139845
Email
hongjin@uic.edu
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjin Li
Email
hongjin@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors

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