Clinical trial · Interventional
Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors
Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors
NCT05615753CI-TRIAL-00087861completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acupuncture group
- 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.
- interventionNames
- Behavioral: Acupuncture
- type
- NO_INTERVENTION
- label
- Usual care group
- description
- Participants will continue to receive their usual care.
Primary outcomes (3)
- measure
- Acceptability for Treating Multiple Symptoms with Acupuncture
- timeFrame
- At week 6 after finishing the 10th acupuncture treatment
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.