Malignant Solid TumorPRACXISNCT03905720
Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services
A study testing Acupuncture and Pain Counseling in people with Malignant Solid Tumor and Pain, run by University of California, San Francisco at 2 sites in United States.
Trial summary
Despite improved assessment and pharmacologic management, cancer pain is still undertreated. Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Malignant Solid Tumor, Pain
- What is being tested?
- Acupuncture and Pain Counseling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
- Speak Cantonese, English, or Spanish
- Have an anticipated stay of ≥ 48 hours
- Be aged 21 or older
- Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled
Who cannot join
- Acupuncture contraindication
- Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
- Admission to the psychiatric ward (e.g., for severe depression)
- Inability to consent (e.g., cognitive impairment)
- Prior involvement with the study (e.g., readmissions)
- Platelets < 50,000 microliters
- Absolute neutrophil count < 500 microliters
- C. difficile infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients
Despite improved assessment and pharmacologic management, cancer pain is still undertreated. Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs. However, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited. Patients want to know "How can I get the most pain relief with the fewest side effects?" This study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.
Read the detailed description
This study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. Study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination.
Participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. Patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers).
The study will be conducted as a pragmatic clinical trial at two hospitals to address these aims:
- Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
- Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
- Examine stakeholder perspectives on non-pharmacologic approaches to pain management.
- Conditions
- Malignant Solid Tumor, Pain
- Being tested
- Acupuncture, Pain Counseling
- Keywords
- cancer, inpatient, non-pharmacologic approaches, pain management, acupuncture, pain counseling
- Medical subject headings
- Pain, Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days.
Pain CounselingBehavioural
Participants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | No intervention | Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer. |
| Acupuncture | Active comparator | Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days. Receives: Procedure: Acupuncture |
| Pain Counseling | Active comparator | Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff. Receives: Behavioral: Pain Counseling |
| Acupuncture and Pain Counseling | Active comparator | Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above. Receives: Procedure: Acupuncture; Behavioral: Pain Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in worst pain intensity assessed by the NRS
Participants' worst level of pain in the past 24 hours on a 0-10 numeric rating scale (NRS), 0= no pain and 10= worst pain imaginable
Measured: Daily for up to four hospital days
Secondary outcomes (4)
Use of opioids during hospital stay
Total and average daily use of opioids based on morphine milligram equivalence
Measured: Hospital stay (average length of stay = 5 days)
Presence and severity of common side effects
Nausea, vomiting, agitation, and sedation
Measured: Daily for up to four hospital days
Cancer-related distress
Single item measure developed by the National Comprehensive Cancer Network. Participants are asked to indicate the number that best describes how much distress they are experiencing in the past week including today, 0=no distress and 10=extreme distress.
Measured: Daily for up to four hospital days
Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)
The EuroQol EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EuroQol visual analogue scale (EQ VAS) records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. Detailed scoring instructions are available: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf
Measured: Daily for up to four hospital days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start17 Jan 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 randomized factorial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Maria T Chao, DrPH, MPA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905720
- Sponsor's protocol ID
- 17-23446
- Other IDs
- NCI-2018-02204, 18801
- Acronym
- PRACXIS
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2018
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients
- ClinicalTrials.gov ID
- NCT03905720
- Acronym / sponsor ID
- PRACXIS / 17-23446
- Conditions
- Malignant Solid Tumor, Pain
- Keywords
- cancer, inpatient, non-pharmacologic approaches, pain management, acupuncture, pain counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite improved assessment and pharmacologic management, cancer pain is still undertreated. Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs. However, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited. Patients want to know "How can I get the most pain relief with the fewest side effects?" This study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.
Detailed description
This study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. Study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination.
Participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. Patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers).
The study will be conducted as a pragmatic clinical trial at two hospitals to address these aims:
- Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
- Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
- Examine stakeholder perspectives on non-pharmacologic approaches to pain management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2x2 randomized factorial design
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | No intervention | –Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer. |
| Acupuncture | Active comparator | Procedure: AcupunctureAlong with routine pain medications, participants will be offered daily acupuncture treatments for up to four days. |
| Pain Counseling | Active comparator | Behavioral: Pain CounselingAlong with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff. |
| Acupuncture and Pain Counseling | Active comparator | Procedure: Acupuncture, Behavioral: Pain CounselingAlong with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
- Speak Cantonese, English, or Spanish
- Have an anticipated stay of ≥ 48 hours
- Be aged 21 or older
- Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled
Key exclusion criteria (8 listed)
- Acupuncture contraindication
- Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
- Admission to the psychiatric ward (e.g., for severe depression)
- Inability to consent (e.g., cognitive impairment)
- Prior involvement with the study (e.g., readmissions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureA licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days. | Procedure or surgery | Acupuncture, Acupuncture and Pain Counseling |
| Pain CounselingParticipants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days. | Behavioural | Acupuncture and Pain Counseling, Pain Counseling |
Primary outcome
Change in worst pain intensity assessed by the NRS
Time frame: Daily for up to four hospital days
Participants' worst level of pain in the past 24 hours on a 0-10 numeric rating scale (NRS), 0= no pain and 10= worst pain imaginable
4 secondary outcomes
Use of opioids during hospital stay
Time frame: Hospital stay (average length of stay = 5 days)
Presence and severity of common side effects
Time frame: Daily for up to four hospital days
Cancer-related distress
Time frame: Daily for up to four hospital days
Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)
Time frame: Daily for up to four hospital days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria T Chao, DrPH, MPA principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Pain Counseling in people with Malignant Solid Tumor and Pain, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in worst pain intensity assessed by the NRS (time frame: Daily for up to four hospital days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.