Cancer-related PainNCT04040140
Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain
A study testing APA Treatment in people with Cancer-related Pain and Acupressure, run by Johns Hopkins University at 1 site in United States.
Trial summary
The aims of this proposal are to (1) examine the feasibility of providing a training course of Auricular Point Acupressure (APA) for clinical oncology nurses who can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on cancer-related pain (CRP) under the usual conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer-related Pain, Acupressure
- What is being tested?
- APA Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 30 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cancer patients with worst pain rated as 4 or more on a 0-10 numeric rating scale in the last 24 hours, which will use the EPIC pain scale
- Able to read and write English
- Able to apply pressure to the seeds taped to the ears. Patients with any cancer type will be eligible for this study so long as the patients are experiencing cancer-related pain
- Owns a smartphone
Who cannot join
- Is delirious
- Has ear skin disease
- Non-English speaker
- Has latex allergy to the tape used for this study
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
The aims of this proposal are to (1) examine the feasibility of providing a training course of Auricular Point Acupressure (APA) for clinical oncology nurses who can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on cancer-related pain (CRP) under the usual conditions.
Read the detailed description
Cancer-related pain (CRP) is considered one of the most challenging symptoms that cancer patients experience. Opioid use is the most common strategy to manage pain. However, pharmacological treatments are associated with a variety of adverse side effects, including drowsiness, constipation, dry mouth, and the potential for addiction. As a result, up to 52% of cancer patients do not receive adequate analgesic medication. The high prevalence of pain and ineffective CRP management highlight the limitations of current CRP strategies. An effective, nonpharmacological patient-managed strategy-that has potential to provide quick and low-cost pain relief without new side effects-is an essential next step to manage CRP.
Auricular point acupressure (APA), a non-invasive and nonpharmacological patient-managed strategy, can be an innovative solution for CRP. APA is derived from Chinese Medicine and is different from auricular acupuncture, which is an invasive (using needles) and passive treatment (administered by a licensed practitioner). APA is a non-invasive and active treatment for patients with pain and other symptoms. It involves needleless, acupuncture-like stimulation of ear points. Small seeds are taped on specific ear points for stimulation by patients. Once the seeds have been taped on the patient's ear by the skilled provider, the patient is able to co-manage patient's treatment at home. APA is popular in Taiwan, China, and Europe. Though its use is limited in the U.S., a limited number of clinical trials have supported APA. To achieve pain relief, the participant presses on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and also sustains pain relief for one month after a 4-week APA intervention. The rapid pain relief makes APA an attractive strategy to manage CRP.
The investigators' team has conducted a series of APA studies among patients with (1) chronic low back pain, (2) aromatase inhibitor musculoskeletal symptoms (AIMSS), (3) persistent post-mastectomy pain, and (4) chemotherapy-induced neuropathy (CIN). All of the investigators' pilot studies demonstrated better than a clinically significant pain reduction (30% reduction) after 4 weeks of APA and sustained effects for 1-month. Significant plasma inflammatory changes (IL-1β, IL-2, IL-6, Tumor Necrosis Factor α, and IFNγ) were found after 4 weeks, indicating that APA may affect brain macrophage-cells resulting in inflammatory cytokines alterations, leading to sustained pain relief at 1-month follow-up. Based on these findings, the investigators believe APA would be particularly suitable to reduce CRP. More importantly, easy implementation of APA and its immediate and lasting pain relief can empower and motivate cancer patients to adhere to APA treatment and allows patients to engage other forms of pain intervention, such as maintaining and/or increasing physical activity as a by-product of improved analgesia.
Nurses are the patient's first line of support in managing CRP; however, nurses have limited tools available to accomplish this. The most common treatments that nurses have at nurses' disposal are the usage of analgesics or referrals to specialty consultations. Once patients are referred, the role of nurses as cohesive guides and caretakers is often lost. To address this dilemma, patients and nurses need access to a therapy that can quickly relieve the pain, which, in turn, reduces the analgesic use and encourages patients and nurses to engage in other pain interventions. Due to the non-invasive characteristic of APA, nurses can learn APA and incorporate it into nurses' practice to provide pain relief and augment the effects of other pain interventions.
The aims of this proposal are to (1) examine the feasibility of providing a training course of APA for clinical oncology nurses which can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on CRP under the usual conditions.
- Conditions
- Cancer-related Pain, Acupressure
- Being tested
- APA Treatment
- Keywords
- Auricular Point Acupressure, Cancer-related Pain, Acupressure, Nursing education
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APA TreatmentOther
Light touch using vaccaria seeds on corresponding ear points related to patient's pain.
| Study group | Role | What they receive |
|---|---|---|
| APA Treatment | Experimental | Oncology patients with a pain rating of four or greater will receive APA treatment for patients' cancer-related pain. The ear points will be determined by the corresponding body points related to the patient's specific pain. Pain data will be tracked by electronic surveys and Electronic Health Records. Receives: Other: APA Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity as assessed by the Brief Pain Inventory (BPI) short form
Pain intensity in the last 24 hours (1) at its worst and (2) on average will both be measured on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Change in Pain Interference as assessed by the Brief Pain Inventory (BPI) short form
Pain interference with general activity, mood, walking ability, normal work, relationships with other people, sleep and enjoyment of life will be measured on a scale of 0 (does not interfere) to 10 (completely interferes).
Measured: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Change in Dose of Analgesic Use
Dose of analgesic use will be collected in electronic health record (EHR) as part of routine nursing assessments for patient care.
Measured: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Secondary outcomes (2)
Change in Fatigue as assessed by a 0 to 10 scale
Fatigue will be measured on a scale of 0 (energetic, no fatigue) to 10 (worst possible fatigue).
Measured: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Change in Quality of Sleep as assessed by a 0 to 10 scale
Sleep quality will be measured on a scale of 0 (very poor) to 10 (very good).
Measured: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start8 Oct 2019
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Why it stopped: Due to Covid 19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer-related PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Hsing Yeh, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040140
- Sponsor's protocol ID
- IRB00183805
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2019
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van de Castle B, Lukkahatai N, Billing BL, Huang X, Wu H, Zhang J, Abdi S, Kameoka J, Smith TJ. Nurse-Administered Auricular Point Acupressure for Cancer-Related Pain. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231198086. doi: 10.1177/15347354231198086.
PubMed 37706457
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain
- ClinicalTrials.gov ID
- NCT04040140
- Acronym / sponsor ID
- IRB00183805
- Conditions
- Cancer-related Pain, Acupressure
- Keywords
- Auricular Point Acupressure, Cancer-related Pain, Acupressure, Nursing education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid 19.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 31 Jul 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.
The aims of this proposal are to (1) examine the feasibility of providing a training course of Auricular Point Acupressure (APA) for clinical oncology nurses who can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on cancer-related pain (CRP) under the usual conditions.
Detailed description
Cancer-related pain (CRP) is considered one of the most challenging symptoms that cancer patients experience. Opioid use is the most common strategy to manage pain. However, pharmacological treatments are associated with a variety of adverse side effects, including drowsiness, constipation, dry mouth, and the potential for addiction. As a result, up to 52% of cancer patients do not receive adequate analgesic medication. The high prevalence of pain and ineffective CRP management highlight the limitations of current CRP strategies. An effective, nonpharmacological patient-managed strategy-that has potential to provide quick and low-cost pain relief without new side effects-is an essential next step to manage CRP.
Auricular point acupressure (APA), a non-invasive and nonpharmacological patient-managed strategy, can be an innovative solution for CRP. APA is derived from Chinese Medicine and is different from auricular acupuncture, which is an invasive (using needles) and passive treatment (administered by a licensed practitioner). APA is a non-invasive and active treatment for patients with pain and other symptoms. It involves needleless, acupuncture-like stimulation of ear points. Small seeds are taped on specific ear points for stimulation by patients. Once the seeds have been taped on the patient's ear by the skilled provider, the patient is able to co-manage patient's treatment at home. APA is popular in Taiwan, China, and Europe. Though its use is limited in the U.S., a limited number of clinical trials have supported APA. To achieve pain relief, the participant presses on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and also sustains pain relief for one month after a 4-week APA intervention. The rapid pain relief makes APA an attractive strategy to manage CRP.
The investigators' team has conducted a series of APA studies among patients with (1) chronic low back pain, (2) aromatase inhibitor musculoskeletal symptoms (AIMSS), (3) persistent post-mastectomy pain, and (4) chemotherapy-induced neuropathy (CIN). All of the investigators' pilot studies demonstrated better than a clinically significant pain reduction (30% reduction) after 4 weeks of APA and sustained effects for 1-month. Significant plasma inflammatory changes (IL-1β, IL-2, IL-6, Tumor Necrosis Factor α, and IFNγ) were found after 4 weeks, indicating that APA may affect brain macrophage-cells resulting in inflammatory cytokines alterations, leading to sustained pain relief at 1-month follow-up. Based on these findings, the investigators believe APA would be particularly suitable to reduce CRP. More importantly, easy implementation of APA and its immediate and lasting pain relief can empower and motivate cancer patients to adhere to APA treatment and allows patients to engage other forms of pain intervention, such as maintaining and/or increasing physical activity as a by-product of improved analgesia.
Nurses are the patient's first line of support in managing CRP; however, nurses have limited tools available to accomplish this. The most common treatments that nurses have at nurses' disposal are the usage of analgesics or referrals to specialty consultations. Once patients are referred, the role of nurses as cohesive guides and caretakers is often lost. To address this dilemma, patients and nurses need access to a therapy that can quickly relieve the pain, which, in turn, reduces the analgesic use and encourages patients and nurses to engage in other pain interventions. Due to the non-invasive characteristic of APA, nurses can learn APA and incorporate it into nurses' practice to provide pain relief and augment the effects of other pain interventions.
The aims of this proposal are to (1) examine the feasibility of providing a training course of APA for clinical oncology nurses which can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on CRP under the usual conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APA Treatment | Experimental | Other: APA TreatmentOncology patients with a pain rating of four or greater will receive APA treatment for patients' cancer-related pain. The ear points will be determined by the corresponding body points related to the patient's specific pain. Pain data will be tracked by electronic surveys and Electronic Health Records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients with worst pain rated as 4 or more on a 0-10 numeric rating scale in the last 24 hours, which will use the EPIC pain scale
- Able to read and write English
- Able to apply pressure to the seeds taped to the ears. Patients with any cancer type will be eligible for this study so long as the patients are experiencing cancer-related pain
- Owns a smartphone
Key exclusion criteria (5 listed)
- Is delirious
- Has ear skin disease
- Non-English speaker
- Has latex allergy to the tape used for this study
- Women who are pregnant
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 |
|---|---|---|
| APA TreatmentLight touch using vaccaria seeds on corresponding ear points related to patient's pain. | Other | APA Treatment |
Primary outcome
Change in Pain Intensity as assessed by the Brief Pain Inventory (BPI) short form
Time frame: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Pain intensity in the last 24 hours (1) at its worst and (2) on average will both be measured on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
Change in Pain Interference as assessed by the Brief Pain Inventory (BPI) short form
Time frame: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Pain interference with general activity, mood, walking ability, normal work, relationships with other people, sleep and enjoyment of life will be measured on a scale of 0 (does not interfere) to 10 (completely interferes).
Change in Dose of Analgesic Use
Time frame: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Dose of analgesic use will be collected in electronic health record (EHR) as part of routine nursing assessments for patient care.
2 secondary outcomes
Change in Fatigue as assessed by a 0 to 10 scale
Time frame: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Change in Quality of Sleep as assessed by a 0 to 10 scale
Time frame: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Results and safety
The study was stopped early (reason given: Due to Covid 19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Derived from this study: PubMed 37706457Van de Castle B, Lukkahatai N, Billing BL, Huang X, Wu H, Zhang J, Abdi S, Kameoka J, Smith TJ. Nurse-Administered Auricular Point Acupressure for Cancer-Related Pain. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231198086. doi: 10.1177/15347354231198086.
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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.
Chao Hsing Yeh, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA Treatment in people with Cancer-related Pain and Acupressure, run by Johns Hopkins University at 1 site 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Due to Covid 19.). Results are not available in the source record.
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 Pain Intensity as assessed by the Brief Pain Inventory (BPI) short form (time frame: Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04040140, which also lists 1 linked publication.
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 13 Aug 2021.