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Group Versus Individual Acupuncture for Cancer Pain

Primary Purpose

Cancer, Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Acupuncture, Group, Community Based, Individual, Randomized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Psychosocial Oncology, Cancer Control Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Acupuncture

Individual Acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Pittsburg Sleep Quality Index
The Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances
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.
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
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
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
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
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)

Full Information

First Posted
July 10, 2018
Last Updated
March 14, 2019
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT03641222
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
Acupuncture, Group, Community Based, Individual, Randomized

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Individual Acupuncture
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Traditional Chinese Medicine (TCM) Acupuncture
Primary Outcome Measure Information:
Title
The Brief Pain Inventory-Short Form
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The Profile of Mood States-Short Form
Description
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).
Time Frame
6 weeks
Title
Pittsburg Sleep Quality Index
Description
The Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances
Time Frame
6 weeks
Title
The Functional Assessment of Cancer Therapy-General
Description
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.
Time Frame
6 weeks
Title
The Functional Assessment of Cancer Therapy - Fatigue
Description
The Functional Assessment of Cancer Therapy-Fatigue (FACT-F) comprised of the FACT-G, plus an additional 13 questions related to fatigue
Time Frame
6 weeks
Title
The Inventory of Socially Supportive Behaviours
Description
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
Time Frame
6 weeks
Title
Edmonton Symptom Assessment Scale
Description
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
Time Frame
6 weeks
Title
A Pain Visual Analog Scale
Description
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
Time Frame
6 weeks
Title
The European Quality of Life-5 Dimensions
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Use of acupuncture within the previous six months. Currently on or within one-month of active treatment (chemotherapy or radiation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda E Carlson, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychosocial Oncology, Cancer Control Alberta
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 3C1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35698124
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.
Results Reference
derived
PubMed Identifier
33904784
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.
Results Reference
derived
PubMed Identifier
33902334
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.
Results Reference
derived

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Group Versus Individual Acupuncture for Cancer Pain

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