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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06117709




Registration number
NCT06117709
Ethics application status
Date submitted
31/10/2023
Date registered
7/11/2023

Titles & IDs
Public title
Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing
Scientific title
Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing
Secondary ID [1] 0 0
23-187
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - I-STAMP

Experimental: I-STAMP Testing - Study procedures will be conducted as follows:

Activities 1-3: Data Collection for application development

Activity 4: To be added with future amendment


BEHAVIORAL: I-STAMP
A patient-facing smartphone application that hosts participants' analgesic and laxative medications, provides pain-specific psychoeducation, collects patient reported outcomes, and provides feedback to participant symptoms.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Usability
Timepoint [1] 0 0
2 weeks
Primary outcome [2] 0 0
E-scale Acceptability
Timepoint [2] 0 0
2 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria for Participants (Activities 1a, 2a, 3a):

* Age = 21 years
* Current or previous diagnosis of advanced cancer
* Current or previous experience with cancer pain
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Participants (Activities 1a, 2a, 3a):

* Inability to understand, speak, or read English
* Any condition that would impede the patient's ability to complete study procedures such as visual impairment or significant cognitive impairment as determined by the participant's treating provider.

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
73
Accrual to date
Final
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
Other
Name [1] 0 0
The Fund for Innovation in Cancer Informatics
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
Andrea Enzinger, MD
Address 0 0
Country 0 0
Phone 0 0
617-582-7335
Fax 0 0
Email 0 0
Andrea_Enzinger@dfci.harvard.edu
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)
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?
DFCI - 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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06117709