Trial Outcomes & Findings for Early Interventional Treatment for Cancer Pain (NCT NCT05366413)

Last Updated: 2025-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

4 Weeks

Results posted on

2025-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Interventional Treatment for Cancer Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Management Strategies n=30 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	59.5 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Arm n=30 Participants 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
Feasibility - Pain Consultation	29 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Arm n=30 Participants 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
Feasibility - Interventional Pain Procedure Rate	18 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Arm n=18 Participants 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
Acceptability - Satisfaction Ratings	15 Participants

Adverse Events

Pain Management Strategies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrea Enzinger, MD

Dana-Farber Cancer Institute

Phone: 617-582-7335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place