CancerNCT03641222
Group Versus Individual Acupuncture for Cancer Pain
A study testing Acupuncture in people with Cancer and Pain, run by University of Calgary at 1 site in Canada.
Trial summary
Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2017to 30 Sep 2018
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult cancer patients (≥18 years old), both male and female.
- Experiencing pain with a minimum worst pain score (in the previous week) ≥3 on the 10-point Brief Pain Inventory (BPI).
- All tumor groups, including metastatic patients.
- Participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain.
- Must be willing to be randomized into either group, and must be able to attend a minimum of nine treatment sessions within a six-week period.
Who cannot join
- Use of acupuncture within the previous six months.
- Currently on or within one-month of active treatment (chemotherapy or radiation).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Psychosocial Oncology, Cancer Control Alberta
Calgary, Alberta, T2N 3C1
About this study
Official title: A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain
Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial.
Read the detailed description
Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Although the practice can vary, community acupuncture is performed in a group setting, typically with reclining chairs dispersed around a large room, and one practitioner treating up to six people per session.
The outcomes of this this randomized controlled trial will allow the researchers to assess whether group acupuncture is a viable treatment option for people with cancer who are suffering from pain, especially those who are either resistant to or looking to avoid the side effects of opioids.
Objectives Examine the efficacy of community acupuncture for alleviating cancer pain, fatigue, sleep disturbances and distress when compared to individual acupuncture.
Evaluate the cost-effectiveness of community acupuncture compared to individual acupuncture.
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Group, Community Based, Individual, Randomized
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Traditional Chinese Medicine (TCM) Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Group Acupuncture | Experimental | Group acupuncture sessions take place in a multipurpose room, with 3-6 participants, each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor. Receives: Device: Acupuncture |
| Individual Acupuncture | Active comparator | Individual acupuncture sessions take place in a multipurpose room, privately each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Brief Pain Inventory-Short Form
The Brief Pain Inventory-Short Form (BPISF) is a widely used self-report measure, originally developed for cancer pain, which measures both pain severity and pain interference
Measured: 6 weeks
Secondary outcomes (8)
The Profile of Mood States-Short Form
The Profile of Mood States-Short Form (POMS-SF) is a validated measure of psychological distress, which calculates Total Mood Disturbance (TMD) using six subscales: fatigue, vigor, tension, depression, anger and confusion (Shacham, 1983). The 37-item questionnaire asks patients to rate how various adjectives relate to how they have felt in the past week, on a Likert scale from zero (not at all) to four (extremely).
Measured: 6 weeks
Pittsburg Sleep Quality Index
The Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances
Measured: 6 weeks
The Functional Assessment of Cancer Therapy-General
The Functional Assessment of Cancer Therapy-General (FACT-G) is a 20-item questionnaire that measures health-related quality of life (HRQOL) within the cancer population. The questionnaire contains four subscales: physical, social/family, emotional and functional well-being.
Measured: 6 weeks
The Functional Assessment of Cancer Therapy - Fatigue
The Functional Assessment of Cancer Therapy-Fatigue (FACT-F) comprised of the FACT-G, plus an additional 13 questions related to fatigue
Measured: 6 weeks
The Inventory of Socially Supportive Behaviours
The Inventory of Socially Supportive Behaviours (ISSB) Short Form is an 18-item questionnaire designed to measure social support, which asks participants to indicate the number of times they have experienced particular behaviours in the past month
Measured: 6 weeks
Edmonton Symptom Assessment Scale
The Edmonton Symptom Assessment Scale (ESAS) is a simple screening measure that can be used to assess various physical and psychological symptoms, originally designed for palliative care patients
Measured: 6 weeks
A Pain Visual Analog Scale
The pain visual analog scale (VAS) consists of a 10 centimetre line on a slip of white paper, with the indicators "no pain at all" on the far-left end, and "worst pain imaginable" on the far-right end
Measured: 6 weeks
The European Quality of Life-5 Dimensions
This utility scoring instrument is intended to provide an overall quality of life evaluation with a scale from 1 (perfect health) to 0 (death) and allows for the calculation of quality adjusted life years (QALYs)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start2 Oct 2017
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda E. Carlson, University of Calgary
- Investigators
- Linda E Carlson, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641222
- Sponsor's protocol ID
- HREBA.CC-17-0237
- Status last verified
- Mar 2019
- First submitted
- 10 Jul 2018
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oberoi D, Reed EN, Piedalue KA, Landmann J, Carlson LE. Exploring patient experiences and acceptability of group vs. individual acupuncture for Cancer-related pain: a qualitative study. BMC Complement Med Ther. 2022 Jun 13;22(1):155. doi: 10.1186/s12906-022-03600-6.
PubMed 35698124Oberoi DV, Longo CJ, Reed EN, Landmann J, Piedalue KL, Carlson LE. Cost-Utility of Group Versus Individual Acupuncture for Cancer-Related Pain Using Quality-Adjusted Life Years in a Noninferiority Trial. J Altern Complement Med. 2021 May;27(5):390-397. doi: 10.1089/acm.2020.0386. Epub 2021 Apr 27.
PubMed 33904784Oberoi D, McLennan A, Piedalue KA, Wayne PM, Jones JM, Carlson LE. Factors Influencing Preference for Intervention in a Comparative Effectiveness Trial of Mindfulness-Based Cancer Recovery and Tai Chi/Qigong in Cancer Survivors. J Altern Complement Med. 2021 May;27(5):423-433. doi: 10.1089/acm.2020.0400. Epub 2021 Apr 27.
PubMed 33902334
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain
- ClinicalTrials.gov ID
- NCT03641222
- Acronym / sponsor ID
- HREBA.CC-17-0237
- Keywords
- Acupuncture, Group, Community Based, Individual, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 21 Aug 2018 (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.
Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial.
Detailed description
Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Although the practice can vary, community acupuncture is performed in a group setting, typically with reclining chairs dispersed around a large room, and one practitioner treating up to six people per session.
The outcomes of this this randomized controlled trial will allow the researchers to assess whether group acupuncture is a viable treatment option for people with cancer who are suffering from pain, especially those who are either resistant to or looking to avoid the side effects of opioids.
Objectives Examine the efficacy of community acupuncture for alleviating cancer pain, fatigue, sleep disturbances and distress when compared to individual acupuncture.
Evaluate the cost-effectiveness of community acupuncture compared to individual acupuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Acupuncture | Experimental | Device: AcupunctureGroup acupuncture sessions take place in a multipurpose room, with 3-6 participants, each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor. |
| Individual Acupuncture | Active comparator | Device: AcupunctureIndividual acupuncture sessions take place in a multipurpose room, privately each session lasts 30-45 minutes, occurring twice-weekly, over the course of six weeks, for a total of twelve treatments. The acupuncture was administered by a Naturopathic Doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult cancer patients (≥18 years old), both male and female.
- Experiencing pain with a minimum worst pain score (in the previous week) ≥3 on the 10-point Brief Pain Inventory (BPI).
- All tumor groups, including metastatic patients.
- Participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain.
- Must be willing to be randomized into either group, and must be able to attend a minimum of nine treatment sessions within a six-week period.
Key exclusion criteria (2 listed)
- Use of acupuncture within the previous six months.
- Currently on or within one-month of active treatment (chemotherapy or radiation).
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 |
|---|---|---|
| AcupunctureTraditional Chinese Medicine (TCM) Acupuncture | Device | Group Acupuncture, Individual Acupuncture |
Primary outcome
The Brief Pain Inventory-Short Form
Time frame: 6 weeks
The Brief Pain Inventory-Short Form (BPISF) is a widely used self-report measure, originally developed for cancer pain, which measures both pain severity and pain interference
8 secondary outcomes
The Profile of Mood States-Short Form
Time frame: 6 weeks
Pittsburg Sleep Quality Index
Time frame: 6 weeks
The Functional Assessment of Cancer Therapy-General
Time frame: 6 weeks
The Functional Assessment of Cancer Therapy - Fatigue
Time frame: 6 weeks
The Inventory of Socially Supportive Behaviours
Time frame: 6 weeks
Edmonton Symptom Assessment Scale
Time frame: 6 weeks
A Pain Visual Analog Scale
Time frame: 6 weeks
The European Quality of Life-5 Dimensions
Time frame: 6 weeks
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 18 Mar 2019.
- Derived from this study: PubMed 35698124Oberoi D, Reed EN, Piedalue KA, Landmann J, Carlson LE. Exploring patient experiences and acceptability of group vs. individual acupuncture for Cancer-related pain: a qualitative study. BMC Complement Med Ther. 2022 Jun 13;22(1):155. doi: 10.1186/s12906-022-03600-6.
- Derived from this study: PubMed 33904784Oberoi DV, Longo CJ, Reed EN, Landmann J, Piedalue KL, Carlson LE. Cost-Utility of Group Versus Individual Acupuncture for Cancer-Related Pain Using Quality-Adjusted Life Years in a Noninferiority Trial. J Altern Complement Med. 2021 May;27(5):390-397. doi: 10.1089/acm.2020.0386. Epub 2021 Apr 27.
- Derived from this study: PubMed 33902334Oberoi D, McLennan A, Piedalue KA, Wayne PM, Jones JM, Carlson LE. Factors Influencing Preference for Intervention in a Comparative Effectiveness Trial of Mindfulness-Based Cancer Recovery and Tai Chi/Qigong in Cancer Survivors. J Altern Complement Med. 2021 May;27(5):423-433. doi: 10.1089/acm.2020.0400. Epub 2021 Apr 27.
- 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.
Linda E Carlson, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Cancer and Pain, run by University of Calgary at 1 site in Canada.
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 2 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 18 Mar 2019. 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 Canada. 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.
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?
The Brief Pain Inventory-Short Form (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641222, which also lists 3 linked publications.
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 18 Mar 2019.