Cancer PainNCT05366413
Early Interventional Treatment for Cancer Pain
A study testing Early Referral and Pain Management Strategies in people with Cancer Pain, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Early Referral and Pain Management Strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2022to 26 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of a metastatic, or locally advanced unresectable malignancy
- Anticipated prognosis of more than 6 months according to the primary oncologist
- Age greater than 21 years
- Persistent pain with an average pain rating of 4 or greater on an 11-point numeric rating scale (NRS) from 0-10 where 10 is considered the most severe.
- Pain has persisted for at least 2 weeks
- Pain is due to cancer or sequelae of cancer treatment
Who cannot join
- Primary pain syndrome is sensory peripheral neuropathy
- Patient is taking more than 200 morphine milligram equivalents (MMEs) per day on average, at the time of recruitment.
- Currently cared for by interventional pain management specialist
- Receipt of prior pain intervention (e.g. celiac neurolysis)
- Bleeding diathesis, uncontrollable infection, or other contra-indications to pain interventions
- History of opioid misuse disorder
Show all 9Show fewer
- Inability to speak English
- Cognitive impairment or any other disorder that would impede study participation and survey completion
- If patients are unable to complete the baseline survey, they will no longer be considered eligible for the study; this will serve as an indication of barriers to participation that would make them unable to comply with study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Pilot Study of Early Referral to Interventional Pain Management for Patients With Advanced Malignancies
The purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer.
Read the detailed description
This is a single arm pilot study evaluating a new system of referral and pain evaluation for patients with advanced solid tumors and moderate-to-severe pain who are not already on high-dose opioids to an anesthesia-trained interventional pain management specialist .
A variety of interventional treatments for pain have been proven effective for cancer patients. Often without early referral patients do not get evaluated for interventional procedures for their pain unless the pain is very severe, or they are admitted to the hospital. It is expect this intervention will work by providing effective pain treatments to patients sooner than they might normally be referred and will be evaluated by how many patients are candidates for interventional treatments for their pain, whether patients choose to receive these treatments, and whether patients find the pain specialist referral acceptable and helpful
The research study procedures include screening for eligibility, study interventions including evaluations and follow up visits, as well as surveys at the beginning, middle, and end of the study. Participants will be followed on the study for 4 months.
It is expected that about 30 people will take part in this research study.
Medtronic and is providing funding for this research study
- Conditions
- Cancer Pain
- Being tested
- Early Referral, Pain Management Strategies
- Keywords
- Cancer Pain
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ReferralOther
Directing a patient for a pain specialist consult earlier than standardly occurs.
Pain Management StrategiesOther
Specialized plan with procedures to ease pain
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive early referral to an anesthesia-trained interventional pain management specialist evaluated for pain management strategies.
Participants will complete surveys every 2 months and will have the option of tracking their pain at home using a secure smartphone application.
Participants will be followed on the study for 4 months. Receives: Other: Early Referral; Other: Pain Management Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Pain Consultation
Feasibility will be measured by the percentage of patients that have an interventional pain consultation within 4 weeks, with a threshold for determining feasibility of at least 80% of participants.
Measured: 4 Weeks
Feasibility - Interventional Pain Procedure Rate
Feasibility will be measured by the percentage of patients who ultimately receive at least one interventional pain procedure, with a threshold for determining feasibility of at least 50% of participants.
Measured: 4 Months
Acceptability - Satisfaction Ratings
Acceptability will be measured by the percentage of patients satisfied with their interventional pain management care, with a threshold of at least 80% of patients rating the quality of care received at the interventional pain management clinic at a 7 or above on a 0-10 scale (adapted from HCAHPS; 0 being the worst clinic possible, 10 being the best clinic possible). For participants with missing data at 4-months, we imputed their responses at 2-months.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start2 Jun 2022
- Primary completion26 Feb 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Andrea Enzinger, MD, Dana-Farber Cancer Institute
- Investigators
- Andrea Enzinger, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366413
- Sponsor's protocol ID
- 21-758
- Status last verified
- Apr 2025
- First submitted
- 4 May 2022
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Early Referral to Interventional Pain Management for Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05366413
- Acronym / sponsor ID
- 21-758
- Conditions
- Cancer Pain
- Keywords
- Cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate how feasible and beneficial it is to refer patients with cancer pain to a doctor who specializes in pain management, including procedures to relieve pain, and whether this is helpful to patients with pain related to their cancer.
Detailed description
This is a single arm pilot study evaluating a new system of referral and pain evaluation for patients with advanced solid tumors and moderate-to-severe pain who are not already on high-dose opioids to an anesthesia-trained interventional pain management specialist .
A variety of interventional treatments for pain have been proven effective for cancer patients. Often without early referral patients do not get evaluated for interventional procedures for their pain unless the pain is very severe, or they are admitted to the hospital. It is expect this intervention will work by providing effective pain treatments to patients sooner than they might normally be referred and will be evaluated by how many patients are candidates for interventional treatments for their pain, whether patients choose to receive these treatments, and whether patients find the pain specialist referral acceptable and helpful
The research study procedures include screening for eligibility, study interventions including evaluations and follow up visits, as well as surveys at the beginning, middle, and end of the study. Participants will be followed on the study for 4 months.
It is expected that about 30 people will take part in this research study.
Medtronic and is providing funding for this research study
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Early Referral, Other: Pain Management StrategiesParticipants will receive early referral to an anesthesia-trained interventional pain management specialist evaluated for pain management strategies. Participants will complete surveys every 2 months and will have the option of tracking their pain at home using a secure smartphone application. Participants will be followed on the study for 4 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of a metastatic, or locally advanced unresectable malignancy
- Anticipated prognosis of more than 6 months according to the primary oncologist
- Age greater than 21 years
- Persistent pain with an average pain rating of 4 or greater on an 11-point numeric rating scale (NRS) from 0-10 where 10 is considered the most severe.
- Pain has persisted for at least 2 weeks
Key exclusion criteria (9 listed)
- Primary pain syndrome is sensory peripheral neuropathy
- Patient is taking more than 200 morphine milligram equivalents (MMEs) per day on average, at the time of recruitment.
- Currently cared for by interventional pain management specialist
- Receipt of prior pain intervention (e.g. celiac neurolysis)
- Bleeding diathesis, uncontrollable infection, or other contra-indications to pain interventions
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 |
|---|---|---|
| Early ReferralDirecting a patient for a pain specialist consult earlier than standardly occurs. | Other | Intervention Arm |
| Pain Management StrategiesSpecialized plan with procedures to ease pain | Other | Intervention Arm |
Primary outcome
Feasibility - Pain Consultation
Time frame: 4 Weeks
Feasibility will be measured by the percentage of patients that have an interventional pain consultation within 4 weeks, with a threshold for determining feasibility of at least 80% of participants.
Feasibility - Interventional Pain Procedure Rate
Time frame: 4 Months
Feasibility will be measured by the percentage of patients who ultimately receive at least one interventional pain procedure, with a threshold for determining feasibility of at least 50% of participants.
Acceptability - Satisfaction Ratings
Time frame: 4 Months
Acceptability will be measured by the percentage of patients satisfied with their interventional pain management care, with a threshold of at least 80% of patients rating the quality of care received at the interventional pain management clinic at a 7 or above on a 0-10 scale (adapted from HCAHPS; 0 being the worst clinic possible, 10 being the best clinic possible). For participants with missing data at 4-months, we imputed their responses at 2-months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Cancer Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Active, not recruitingPhase 3
Effect of Olanzapine on Opioid Craving and Misuse Among Patients Receiving Opioids for Cancer-related Pain: A Pilot Double-Blind, Randomized Control Trial
Misuse, Opioid
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.
Andrea Enzinger, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Referral and Pain Management Strategies in people with Cancer Pain, run by Dana-Farber Cancer Institute 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 6 inclusion and 9 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 16 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility - Pain Consultation (time frame: 4 Weeks). 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?
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 16 Apr 2025.