Balancing Method for Pain Related to Advanced Cancer seeks to confirm the benefit of acupuncture for patients with pain related to advanced cancer.
Pain is common among patients with cancer, with estimates as high as 90% for those with advanced disease. Opioid medication, the most common treatment, has potential adverse effects including nausea and fatigue, further interfering with quality of life. Acupuncture has been studied for the treatment of cancer-related pain, with promising results in a few methodologically sound studies with small sample size. Prior studies have found beneficial effects of open treatment using a Traditional Chinese Medicine (TCM)-based acupuncture protocol and Dr. Tan's Balancing Method. This open trial seeks to confirm the benefit of acupuncture, utilizing Dr. Tan's Balancing Method, for patients with pain related to advanced cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
6
Acupuncture involves inserting thin needles into precise points on the body, known as acupuncture points, for therapeutic effect. Acupuncture will be provided by a licensed acupuncturist utilizing Dr. Tan's Balancing Method.
UPMC Center for Integrative Medicine
Pittsburgh, Pennsylvania, United States
Measuring effectiveness of acupuncture by assessing change in pain ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Numeric Rating Scale v.1.0 - Pain Intensity 1a (NRS)
Participant report of pain on average on a scale from 'no pain' (0) to "worst imaginable pain" (10). Higher scores mean worse outcome.
Time frame: Baseline, each visit; up to 18 weeks (per participant)
Measuring effectiveness of acupuncture by assessing change in pain intensity ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Pain Intensity Scale
Participant report of symptoms in the past week on a scale from "no pain" (1) to "very severe" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.
Time frame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
Measuring effectiveness of acupuncture by assessing change in pain interference ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Pain Interference Short Form 4a
Participant report of symptoms in the past week on a scale from "not at all" (1) to "very much" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.
Time frame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
Measuring effectiveness of acupuncture by assessing change in fatigue ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Fatigue Short Form 4a
Participant report of symptoms in the past week on a scale from "not at all" (1) to "very much" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.
Time frame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
Measuring effectiveness of acupuncture by assessing change in anxiety symptom ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Emotional Distress-Anxiety - Short Form 4a
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Participant report of symptoms in the past week on a scale from "never" (1) to "always" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.
Time frame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
Measuring effectiveness of acupuncture by assessing change in sleep disturbance ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Sleep Disturbance - Short Form 4a
Participant report of symptoms in the past week on a scale from "very poor/very much" (1) to "very good/not at all" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.
Time frame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
Measuring effectiveness of acupuncture by assessing change in gastrointestinal symptom ratings Weekly from Week 1-Week 12 and 4 week follow-up using PROMIS ® Item Bank v.1.0 measures: Gastrointestinal Nausea and Vomiting
Participant report of symptoms in the past week on a scale from "never" (1) to "always" (5). Higher scores mean worse outcome. These measures assess changes in symptoms over the course of study participation.
Time frame: Baseline, each week, at follow-up; up to 18 weeks (per participant)
Measuring effectiveness of acupuncture by assessing improvement in global symptoms ratings at Week 4 and Weeks 9-12 and 4 week follow-up using Patient Global Index of Change: Improvement (PGIC-I)
Participant rating of symptom severity on a scale of -2 (much better) to 2 (much worse). Higher scores mean worse outcome. This measure assesses changes in symptoms over the course of study participation.
Time frame: Week 5, Weeks 9-12 and follow-up; up to 18 weeks (per participant)
Measuring health intervention attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Treatment Expectancy (HEAL-TEX)
Participant report of treatment expectancy on a 5 point scale (1-5) ranging from "Not at all" (1) to "Very much" (5). Higher scores ("Very much") indicate higher treatment expectancy.
Time frame: Baseline Visit
Measuring perception of effectiveness based on patient-provider connections by using Healing Encounters Attitudes List: Perception of the Patient-Provider Connection (HEAL-PPC)
Participant report of the patient-provider connection on a 5 point scale ranging from "Not at all" to "Very much". Higher scores ("Very much") mean better outcome. This measure assesses a change in the patient-provider connection from the beginning of study participation to the end.
Time frame: Week 4 and Weeks 9, 10, 11, 12
Measuring spiritual attitudes and beliefs at start of study by using Healing Encounters Attitudes List Measures: Spirituality (HEAL-SPT)
Participant report of Spirituality on a 5 point scale (1-5) ranging from "Not at all" (1) to "Very much" (5). Higher scores ("Very much") indicate higher personal spiritual belief.
Time frame: Baseline Visit
Monitoring and recording use of opioids throughout the study protocol using Opioid Use Questionnaire
Internally-developed, participant report of pain medication use. This questionnaire collects dosing/frequency information, which is used to calculate morphine equivalent dosing (MED). This information will be used to assess change in pain medication use over the course of study participation.
Time frame: Baseline; weekly; follow-up; up to 18 weeks (per participant)
Assessing for treatment-related adverse events as recorded by Acupuncture Safety Record
Internally-developed, participant report of acupuncture related adverse events. Administered in a checklist form. More selections on this form means more acupuncture related adverse events.
Time frame: Baseline; each visit and follow-up; up to 18 weeks (per participant)
Assessing for treatment-related and illness-related symptoms as recorded by Symptoms Checklist (SC)
Captures new or worsening health problems participants have experienced since their last study visit. More selections on this form means worse outcome.
Time frame: Baseline; each visit and follow-up; up to 18 weeks (per participant)