NCT03641222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

July 10, 2018

Last Update Submit

March 14, 2019

Conditions

CancerPain

Keywords

AcupunctureGroupCommunity BasedIndividualRandomized

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks

Secondary Outcomes (8)

  • The Profile of Mood States-Short Form

    6 weeks

  • Pittsburg Sleep Quality Index

    6 weeks

  • The Functional Assessment of Cancer Therapy-General

    6 weeks

  • The Functional Assessment of Cancer Therapy - Fatigue

    6 weeks

  • The Inventory of Socially Supportive Behaviours

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Device: Acupuncture

Interventions

AcupunctureDEVICE

Traditional Chinese Medicine (TCM) Acupuncture

Group AcupunctureIndividual Acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychosocial Oncology, Cancer Control Alberta

Calgary, Alberta, T2N 3C1, Canada

Location

Related Publications (3)

  • 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.

    PMID: 35698124DERIVED

  • 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.

    PMID: 33904784DERIVED

  • 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.

    PMID: 33902334DERIVED

MeSH Terms

Conditions

NeoplasmsPain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Linda E Carlson, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Oncology

Study Record Dates

First Submitted

July 10, 2018

First Posted

August 21, 2018

Study Start

October 2, 2017

Primary Completion

August 30, 2018

Study Completion

September 30, 2018

Last Updated

March 18, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)