Trial Outcomes & Findings for Smartphone Technology to Alleviate Malignant Pain (STAMP) (NCT NCT03717402)

NCT ID: NCT03717402

Last Updated: 2023-06-05

Results Overview

We will calculate the frequency that patients log in to the application using simple descriptive statistics.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 4 Weeks
• Results posted on: 2023-06-05

Participant Flow

20 participants where consented and enrolled on this single-arm intervention study.

Participant milestones

Measure	Intervention Participants Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smartphone Technology to Alleviate Malignant Pain (STAMP)

Baseline characteristics by cohort

Measure	Intervention Participants n=20 Participants Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Age, Continuous	57.5 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants
Race/Ethnicity, Customized I don't know	0 Participants n=5 Participants
Ethnicity Non-Hispanic/LatinX	20 Participants n=5 Participants
Ethnicity Hispanic/LatinX	0 Participants n=5 Participants
Education Some high school	0 Participants n=5 Participants
Education High school diploma	3 Participants n=5 Participants
Education Some college (AA, other)	6 Participants n=5 Participants
Education College degree (BA, BS, other)	5 Participants n=5 Participants
Education Higher level degree (MA, MS, MD, PhD, other)	5 Participants n=5 Participants
Education Missing	1 Participants n=5 Participants
Marital Status Single	1 Participants n=5 Participants
Marital Status Married	17 Participants n=5 Participants
Marital Status Widowed	0 Participants n=5 Participants
Marital Status Separated	1 Participants n=5 Participants
Marital Status Divorced	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

We will calculate the frequency that patients log in to the application using simple descriptive statistics.

Outcome measures

Measure	Intervention Participants n=20 Participants Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Frequency of Patient Log Ins	14 log ins to the application per patient Interval 9.0 to 17.0

PRIMARY outcome

Timeframe: 4 weeks

We will calculate the number of times patients completed a symptom survey on app during their 28 days on study. Patients could complete up to one symptom survey per day on study.

Outcome measures

Measure	Intervention Participants n=20 Participants Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Frequency of Symptom Survey Completion	8 completed symptom survey(s) per patient Interval 5.0 to 14.0

SECONDARY outcome

Timeframe: 4 Weeks

Patients will rate overall acceptability of the application using a modified acceptability e-scale. This 6-item measure asks patients to rate the app on ease of use, understandability, enjoyment, helpfulness, time spent, and overall satisfaction, on a 1 to 5 Likert scale. Items are summed to for a total score, ranging from 6 to 30 with 30 being the highest acceptability score.

Outcome measures

Measure	Intervention Participants n=20 Participants Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
E-scale Acceptability	24 score on the acceptability scale Standard Deviation 4.37

SECONDARY outcome

Timeframe: 4 Weeks

Patients will complete a validated 10-item system usability scale (SUS) with total scores ranging from 0-100, where a score of 100 being the best possible usability score.

Outcome measures

Measure	Intervention Participants n=20 Participants Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Usability	78.3 score on the SUS scale Standard Deviation 16.2

Adverse Events

Intervention Participants

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention Participants n=20 participants at risk Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Social circumstances Consent form error	100.0% 20/20 • Number of events 20 • 1 year

Additional Information

Andrea C. Enzinger, MD

Dana-Farber Cancer Institute

Phone: 617-582-7335

Email: Andrea_Enzinger@DFCI.HARVARD.EDU

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place