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Group Versus Individual Acupuncture for Cancer Pain

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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

Tracking Information
First Submitted Date  ICMJE July 10, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE October 2, 2017
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03641222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • 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).
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Versus Individual Acupuncture for Cancer Pain
Official Title  ICMJE A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Pain
Intervention  ICMJE Device: Acupuncture
Traditional Chinese Medicine (TCM) Acupuncture
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Device: Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2019)
76
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
75
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03641222
Other Study ID Numbers  ICMJE HREBA.CC-17-0237
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Linda E. Carlson, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda E Carlson, PhD University of Calgary
PRS Account University of Calgary
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP