Cancer Pain
Conditions
Keywords
Cancer Pain
Brief 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.
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
Interventions
OTHEREarly Referral
Directing a patient for a pain specialist consult earlier than standardly occurs.
OTHERPain Management Strategies
Specialized plan with procedures to ease pain
Sponsors
Medtronic
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Pain Consultation | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pain Management Strategies 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.
Early Referral: Directing a patient for a pain specialist consult earlier than standardly occurs.
Pain Management Strategies: Specialized plan with procedures to ease pain | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Pain Management Strategies |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 59.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: 4 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Acceptability - Satisfaction Ratings | 15 Participants |
Primary
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.
Time frame: 4 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Feasibility - Interventional Pain Procedure Rate | 18 Participants |
Primary
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.
Time frame: 4 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Feasibility - Pain Consultation | 29 Participants |