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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05366413




Registration number
NCT05366413
Ethics application status
Date submitted
4/05/2022
Date registered
9/05/2022

Titles & IDs
Public title
Early Interventional Treatment for Cancer Pain
Scientific title
Pilot Study of Early Referral to Interventional Pain Management for Patients With Advanced Malignancies
Secondary ID [1] 0 0
21-758
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Pain 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early Referral
Other interventions - Pain Management Strategies

Experimental: 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.


Other interventions: Early Referral
Directing a patient for a pain specialist consult earlier than standardly occurs.

Other interventions: Pain Management Strategies
Specialized plan with procedures to ease pain
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain Consultation Participation Rate
Timepoint [1] 0 0
4 Weeks up to 4 months
Primary outcome [2] 0 0
Pain Care Participation Rate
Timepoint [2] 0 0
4 Weeks up to 4 months
Primary outcome [3] 0 0
Satisfaction Ratings
Timepoint [3] 0 0
4 Weeks up to 4 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary pain syndrome is sensory peripheral neuropathy
* Patient is taking more than 90 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

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/12/2024
Actual
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Dana-Farber Cancer Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Enzinger, MD
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Data can be shared no earlier than 1 year following the date of publication
Available to whom?
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05366413