None listed
Conditions
Brief summary
Brief description of the study purpose This study aims to evaluate the effectiveness and cost effectiveness of acupuncture in managing symptom clusters among breast cancer survivors, compared to usual care. Who is it for? You may be eligible for this study if you are a female aged 18 and older, diagnosed with breast cancer (excluding DCIS) who are experiencing multiple moderate symptoms (score >=4/10 for at least two symptoms such as hot flushes, pain, or memory concerns) and have completed active cancer treatment (with no additional active cancer treatment planned for the next 3 months). Study details Participants who are eligible will be randomly assigned to receive either acupuncture or usual care. The acupuncture group will receive eight 40 minute sessions over 8 weeks, delivered face to face by registered practitioners using single-use needles, followed by 4 weeks of follow-up. The control group will receive usual care for 12 weeks and will then be provided with a guided acupressure protocol. Participants may undergo assessments such as symptom scoring using numeric rating scales to monitor changes over time. It is hoped that the result from this study will provide evidence on whether acupuncture is an effective and cost-efficient intervention, supporting improved symptom management and access to supportive care for breast cancer survivors.
Interventions
Acupuncture, eight 40 minute treatments across 8 weeks, and 4 weeks follow up. Stainless steel, single use needles will be used. Delivered individually and face to face by Australian Health Practitioner Regulation Agency (AHPRA) registered acupuncturists. Needle sites will be personalised using a semi-standardised protocol based on a manualisation guide and Traditional Chinese Medicine diagnosis by the attending acupuncturist. Delivered at outpatient clinic/hospital setting. Attendance to schedu
Acupuncture, eight 40 minute treatments across 8 weeks, and 4 weeks follow up. Stainless steel, single use needles will be used. Delivered individually and face to face by Australian Health Practitioner Regulation Agency (AHPRA) registered acupuncturists. Needle sites will be personalised using a semi-standardised protocol based on a manualisation guide and Traditional Chinese Medicine diagnosis by the attending acupuncturist. Delivered at outpatient clinic/hospital setting. Attendance to scheduled acupuncture appointments will be recorded for monitoring adherence.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Diagnosed with breast cancer (excluding Ductal Carcinoma In Situ (DCIS)) - Over the age of 18 - Experience the symptom cluster o At least 4 or more in a scale of 0-10 (Numeric rating scale) o For 2 or more of the symptoms in the selected cluster (eg. hot flushes, memory concerns, pain, numbness/tingling) - Able to commit to the study protocol - Not currently undergoing neo/adjuvant chemotherapy or radiotherapy o Breast cancer survivors who are on adjuvant endocrine therapy (AET) and long term (>3 months) maintenance immunotherapy, targeted therapy or combined therapy will be eligible to participate - No plans for additional chemotherapy, radiotherapy, or other systemic therapy or surgery in the next 3 months - Has been at least 4 weeks since the completion of chemotherapy or radiotherapy - If on long term maintenance treatment, has been at least 4 weeks since commencement.
Exclusion criteria
- Has metastatic cancer - Has recurrent cancer - Pregnant - Has thrombocytopenia ( <= 80) - Has neutropenia - Participating in another trial that addresses the symptoms in this cluster - Started on pharmacological intervention for the symptoms in this cluster for less than 1 month - Has received acupuncture in the last 2 weeks - Participants with demand type pacemakers will be allowed to participate, but will be excluded from receiving electroacupuncture on the trunk
Outcome results
None listed