Breast CancerPhase 1NCT05615753
Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors
A Phase 1 study testing Acupuncture in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60601
About this study
Official title: Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureBehavioural
All participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location,
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes. Receives: Behavioral: Acupuncture |
| Usual care group | No intervention | Participants will continue to receive their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At week 6 after finishing the 10th acupuncture treatment
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
Measured: : from the activation of the study to the completion of the recruitment, week 12
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start12 Jan 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongjin Li, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615753
- Sponsor's protocol ID
- 2022-0353
- Status last verified
- Feb 2025
- First submitted
- 25 Oct 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05615753
- Acronym / sponsor ID
- 2022-0353
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Behavioral: AcupunctureParticipants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes. |
| Usual care group | No intervention | –Participants will continue to receive their usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAll participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location, | Behavioural | Acupuncture group |
Primary outcome
Acceptability for Treating Multiple Symptoms with Acupuncture
Time frame: At week 6 after finishing the 10th acupuncture treatment
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)
Time frame: : from the activation of the study to the completion of the recruitment, week 12
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.
Time frame: Through study completion, an average of 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture in people with Breast Cancer, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability for Treating Multiple Symptoms with Acupuncture (time frame: At week 6 after finishing the 10th acupuncture treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.