Clinical trial NCT03641222: Group Versus Individual Acupuncture for Cancer Pain
Official title: A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Keywords: Acupuncture
Group
Community Based
Individual
Randomized
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Adult cancer patients (≥18 years old), both male and female.
2. Experiencing pain with a minimum worst pain score (in the previous week) ≥3 on the 10-point Brief Pain Inventory (BPI).
3. All tumor groups, including metastatic patients.
4. Participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain.
5. 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.

Exclusion Criteria:

1. Use of acupuncture within the previous six months.
2. Currently on or within one-month of active treatment (chemotherapy or radiation).

Primary outcomes:
measure: The Brief Pain Inventory-Short Form
timeFrame: 6 weeks
Secondary outcomes:
measure: The Profile of Mood States-Short Form
timeFrame: 6 weeks
measure: Pittsburg Sleep Quality Index
timeFrame: 6 weeks
measure: The Functional Assessment of Cancer Therapy-General
timeFrame: 6 weeks
measure: The Functional Assessment of Cancer Therapy - Fatigue
timeFrame: 6 weeks
measure: The Inventory of Socially Supportive Behaviours
timeFrame: 6 weeks
measure: Edmonton Symptom Assessment Scale
timeFrame: 6 weeks
measure: A Pain Visual Analog Scale
timeFrame: 6 weeks
measure: The European Quality of Life-5 Dimensions
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Psychosocial Oncology, Cancer Control Alberta
state: Alberta
Study officials:
affiliation: University of Calgary
name: Linda E Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Oberoi 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.
citation: Oberoi 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.