MedDataX Logo

Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

NCT ID: NCT03905720

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
2. Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
3. Examine stakeholder perspectives on non-pharmacologic approaches to pain management.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Solid Tumor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 randomized factorial design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment As Usual

Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.

Group Type NO_INTERVENTION

No interventions assigned to this group

Acupuncture

Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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 Counseling

Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.

Group Type ACTIVE_COMPARATOR

Pain Counseling

Intervention Type BEHAVIORAL

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.

Acupuncture and Pain Counseling

Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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 Counseling

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupuncture

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.

Intervention Type PROCEDURE

Pain Counseling

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
2. Speak Cantonese, English, or Spanish
3. Have an anticipated stay of ≥ 48 hours
4. Be aged 21 or older
5. Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled

Exclusion Criteria

1. Acupuncture contraindication
2. Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
3. Admission to the psychiatric ward (e.g., for severe depression)
4. Inability to consent (e.g., cognitive impairment)
5. Prior involvement with the study (e.g., readmissions)
6. Platelets \< 50,000 microliters
7. Absolute neutrophil count \< 500 microliters
8. C. difficile infection
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria T Chao, DrPH, MPA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2018-02204

Identifier Type: REGISTRY

Identifier Source: secondary_id

18801

Identifier Type: OTHER

Identifier Source: secondary_id

17-23446

Identifier Type: -

Identifier Source: org_study_id