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Group Versus Individual Acupuncture for Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03641222
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Linda E. Carlson, University of Calgary

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Pain Device: Acupuncture Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group Acupuncture
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
Traditional Chinese Medicine (TCM) Acupuncture
Active Comparator: Individual Acupuncture
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
Traditional Chinese Medicine (TCM) Acupuncture


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The Profile of Mood States-Short Form [ Time Frame: 6 weeks ]
    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).

  2. Pittsburg Sleep Quality Index [ Time Frame: 6 weeks ]
    The Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances

  3. The Functional Assessment of Cancer Therapy-General [ Time Frame: 6 weeks ]
    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.

  4. The Functional Assessment of Cancer Therapy - Fatigue [ Time Frame: 6 weeks ]
    The Functional Assessment of Cancer Therapy-Fatigue (FACT-F) comprised of the FACT-G, plus an additional 13 questions related to fatigue

  5. The Inventory of Socially Supportive Behaviours [ Time Frame: 6 weeks ]
    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

  6. Edmonton Symptom Assessment Scale [ Time Frame: 6 weeks ]
    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

  7. A Pain Visual Analog Scale [ Time Frame: 6 weeks ]
    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

  8. The European Quality of Life-5 Dimensions [ Time Frame: 6 weeks ]
    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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641222


Locations
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Canada, Alberta
Psychosocial Oncology, Cancer Control Alberta
Calgary, Alberta, Canada, T2N 3C1
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Linda E Carlson, PhD University of Calgary
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Linda E. Carlson, Professor, Department of Oncology, University of Calgary
ClinicalTrials.gov Identifier: NCT03641222    
Other Study ID Numbers: HREBA.CC-17-0237
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Linda E. Carlson, University of Calgary:
Acupuncture
Group
Community Based
Individual
Randomized
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations