Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000590763
Ethics application status
Approved
Date submitted
1/04/2022
Date registered
21/04/2022
Date last updated
20/10/2022
Date data sharing statement initially provided
21/04/2022
Date results information initially provided
20/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture for treating a symptom cluster (pain, fatigue, sleep and neuropathy) for women with breast cancer: a feasibility study
Scientific title
Acupuncture for treating a symptom cluster (pain, fatigue, sleep and neuropathy) for women with breast cancer: a feasibility study
Secondary ID [1] 306740 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 325744 0
Condition category
Condition code
Cancer 323081 323081 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single arm acupuncture intervention.
Therapist: Provided by acupuncturists registered with Australian Health Practitioner Regulation Agency (AHPRA), who are trained in oncology acupuncture with experience of at least 5 years.
Duration/frequency: Total of 8 treatments over 6 weeks will be provided. Each session will be 40 minutes, with the first consult 60 minutes. The first 2 weeks will be twice a week intervention then once a week for the rest of the 4 weeks.
Equipment: Vinco acupuncture needles will be used. Where appropriate, the electro-acupuncture machine (Model ES160 Ito Co Ltd) will be used.
Location: all intervention will be performed at the Chris O'Brien Lifehouse as face to face interventions.
Protocol: all intervention will be personalized based on the Traditional Chinese Medicine diagnosis made by the clinician.
Intervention code [1] 323187 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330843 0
Acceptability: measured using the Acceptability of Intervention Measure questionnaire, collected through redCACP data collection software
Timepoint [1] 330843 0
6 weeks after starting treatment (at the endpoint)
Primary outcome [2] 331060 0
Feasibility: measured using the Feasibility of Intervention Measure questionnaire, collected through redCAP data collection software
Timepoint [2] 331060 0
6 weeks after starting treatment (at the endpoint)
Primary outcome [3] 331061 0
Appropriateness: measured using Intervention Appropriateness Measure questionnaire, collected through redCACP data collection software
Timepoint [3] 331061 0
6 weeks after starting treatment (at the endpoint)
Secondary outcome [1] 407795 0
symptom burden, measured using the Edmonton Symptom Assessment Scale, collected through redCACP data collection software
Timepoint [1] 407795 0
at baseline (start of trial), 6 weeks after starting treatment (at the endpoint) and 8 weeks after starting treatment (follow-up)
Secondary outcome [2] 407796 0
Quality of life, measured using the Patient Reported Outcome Measure Information System (PROMIS) self report measure. We will use the PROMIS-29 v2.0 profile items (Hays et al, 2018) collected through REDCap data collection software.
Timepoint [2] 407796 0
at baseline (start of trial), 6 weeks after starting treatment (at the endpoint) and 8 weeks after starting treatment (follow-up)
Secondary outcome [3] 408610 0
credibility and expectancy of participants: Credibility and Expectancy questionnaire, collected through redCACP data collection software
Timepoint [3] 408610 0
at baseline (start of trial), 6 weeks after starting treatment (at the endpoint)

Eligibility
Key inclusion criteria
- breast cancer diagnosis
- completed cancer modifying treatment
- female
- moderate to severe symptom burden of sleep disturbance, fatigue, pain and neuropathy. Moderate to severe symptom burden is defined as scoring greater than or equal to 4 on the ESAS-17 for two or more of these items.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recurrent or metastatic cancer
- Pregnancy
- Received acupuncture in the last 2 weeks
- Currently Receiving chemotherapy or radiotherapy
- Under 18 years old
- Persisting thrombocytopenia (Platelets < or = 80)
- Known coagulopathy
- Demand Pacemaker in situ: can participate but excluded from receiving electroacupuncture

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/04/2022
Actual
12/06/2022
Date of last participant enrolment
Anticipated
31/08/2022
Actual
23/08/2022
Date of last data collection
Anticipated
25/10/2022
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22104 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 37228 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311075 0
Hospital
Name [1] 311075 0
Chris O'Brien Lifehouse
Country [1] 311075 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 312407 0
None
Name [1] 312407 0
Address [1] 312407 0
Country [1] 312407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310614 0
St Vincent's Human Research Ethics Committee
Ethics committee address [1] 310614 0
390 Victoria St, Darlinghurst NSW 2010
Ethics committee country [1] 310614 0
Australia
Date submitted for ethics approval [1] 310614 0
Approval date [1] 310614 0
24/02/2022
Ethics approval number [1] 310614 0

Summary
Brief summary
The purpose of this study is to look at the feasibility of acupuncture for treating 'symptom cluster' (such as pain, sleep disturbance, and fatigue) in patients who have had breast cancer treatment.
Who is it for?
You may be eligible for this study if you are a female aged 18 years or above, and have completed your treatment for breast cancer.
Study details
All participants will be treated with 8 sessions of acupncture over 6 weeks at the Chris O'Brien Lifehouse. Participants will be asked to attend all treatment sessions and complete a set of questionnaires at the start, the completion and 2 weeks after the completion of the trial.

It is hoped that this research will reveal if acupuncture is appropriate for improving the symptoms experienced after breast cancer treatment, thus improving the quality of life of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118270 0
Dr Suzanne Grant
Address 118270 0
National Institute of Complementary Medicine, 158-160 Hawkesbury Rd, Westmead NSW 2145
Country 118270 0
Australia
Phone 118270 0
+61 2 9685 4747
Fax 118270 0
Email 118270 0
s.grant@westernsydney.edu.au
Contact person for public queries
Name 118271 0
Dr Suzanne Grant
Address 118271 0
National Institute of Complementary Medicine, 158-160 Hawkesbury Rd, Westmead NSW 2145
Country 118271 0
Australia
Phone 118271 0
+61 2 9685 4747
Fax 118271 0
Email 118271 0
s.grant@westernsydney.edu.au
Contact person for scientific queries
Name 118272 0
Dr Suzanne Grant
Address 118272 0
National Institute of Complementary Medicine, 158-160 Hawkesbury Rd, Westmead NSW 2145
Country 118272 0
Australia
Phone 118272 0
+61 2 9685 4747
Fax 118272 0
Email 118272 0
s.grant@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data obtained through this study may be provided to qualified researchers with academic interest in acupuncture for symptom clusters. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
When will data be available (start and end dates)?
available for 5 years after publication
Available to whom?
Qualified researchers engaging in independent scientific research, provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Available for what types of analyses?
Submission of a Statistical Analysis Plan (SAP) - all types of deidentified analysis will be considered.
How or where can data be obtained?
For more information or to submit a request, please contact justine.stehn@Lh.org.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.