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Smartphone Technology to Alleviate Malignant Pain (STAMP)

Smartphone Technology to Alleviate Malignant Pain (STAMP): Development and Piloting of a Novel mHealth Intervention to Support Cancer Patients, Nurses, and Physicians in Opioid Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717402
Enrollment
20
Registered
2018-10-24
Start date
2018-11-01
Completion date
2022-05-01
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Opioid Use, Pain Management

Keywords

Cancer, Pain management, Opioid use, Health app, Gastrointestinal cancer, Breast cancer, Lung cancer

Brief summary

The purpose of the study is to develop the STAMP app (Smartphone Technology to Alleviate Malignant Pain). This app will be used by patients with advanced cancer to track symptoms and receive tailored symptom management advice. This is a single arm pilot feasibility study of the application among patients with advanced cancer and chronic pain who are using opioids in the home setting. Patients will be asked to use the application for a four week period. Clinicians responsible for the patients' pain management will be asked to review alerts from the STAMP system and respond accordingly. The primary outcomes of the study relate to feasibility and acceptability.

Detailed description

A pilot study will be conducted at DFCI to demonstrate the utilization and efficacy of the STAMP app among patients with chronic cancer pain and their cancer care providers. This will be a single arm study with up to 20 patients. Patients with advanced solid tumors who are using opioids to manage chronic cancer pain will be recruited from outpatient clinics (palliative care), and they will be asked to use the app for 4 weeks. Once a patient is enrolled in the study, a research assistant (RA) will set up the app, putting in the patient's prescribed opioids and laxatives. Patient will have access to educational materials about pain management and patient educational videos about pain management and opioids through the app. Patient will be prompted to take daily surveys for symptom reporting and medication updates. At the end of each survey patients receive, a summary of their symptom severity, with links to tailored educational content about pain management, and recommendations about how to safely titrate over-the-counter laxatives to manage opioid-induced constipation. This laxative advice operates within the parameters of normative and approved over-the-counter laxative use, and has been extensively reviewed, vetted, and approved by multidisciplinary groups of clinicians. If patients report any severe symptoms, they are instructed to contact their care team immediately, with a telephone number included on the application screen. If patients' pain is poorly controlled but not severe enough to be prompted to immediately contact their care team (for example if their average pain is above a 4 and not acceptable), they are reminded to contact their care teams if their symptoms worsen or they are concerned about it. Finally, if they report any concerning abdominal symptoms (e.g. no bowel movement in 4 or more days, haven't passed gas from bottom or ostomy, new or severe abdominal pain, vomiting two or more times in the past 24 hours), patients are not given any laxative titration instructions and are instead advised to contact their care team for more advice. The research team will monitor the portal where patient survey responses are presented. If a severe symptom is reported, the research team will contact the relevant nursing staff for clinical follow-up (as per the above paragraph, patients are always advised to contact their care teams for safety concerns, and there is no expectation for immediate nurse outreach). Nurses and physicians involved in the care of participating patients will also have access to patient-responses on the clinician portal. Participants will complete a brief survey at baseline and again at end of study (4 weeks). They will also be offered an optional qualitative debriefing at end of study.

Interventions

BEHAVIORALIntervention Participants

Patients with advances cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient Inclusion Criteria: * Patient is cared for within participating clinic (PC) * Age ≥21 * Diagnosed with locally advanced, metastatic solid tumor, or multiple myeloma being managed with palliative intent * Chronic pain related to cancer or cancer treatment, persisting or at least two weeks * Average pain rating of ≥4/10 currently, or at least one day within the past week * Active prescription for short and/or long acting opioids * Takes at least 1 opioid medication on most days * Own a compatible smartphone: * iPhone, have updated or willing to update it to the past 3 iOS version releases * Android flagship devices with more than 5% market share, last 2 android version releases Clinician Inclusion Criteria: * Physicians and mid-level providers practicing in participating clinics and caring for a patient on the study * Nurse Navigators working within participating clinics

Exclusion criteria

Patient

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Patient Log Ins4 WeeksWe will calculate the frequency that patients log in to the application using simple descriptive statistics.
Frequency of Symptom Survey Completion4 weeksWe 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.

Secondary

MeasureTime frameDescription
E-scale Acceptability4 WeeksPatients 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.
Usability4 WeeksPatients 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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
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.
20
Total20

Baseline characteristics

CharacteristicIntervention Participants
Age, Continuous57.5 years
STANDARD_DEVIATION 12.3
Education
College degree (BA, BS, other)
5 Participants
Education
Higher level degree (MA, MS, MD, PhD, other)
5 Participants
Education
High school diploma
3 Participants
Education
Missing
1 Participants
Education
Some college (AA, other)
6 Participants
Education
Some high school
0 Participants
Ethnicity
Hispanic/LatinX
0 Participants
Ethnicity
Non-Hispanic/LatinX
20 Participants
Marital Status
Divorced
1 Participants
Marital Status
Married
17 Participants
Marital Status
Separated
1 Participants
Marital Status
Single
1 Participants
Marital Status
Widowed
0 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
0 Participants
Race/Ethnicity, Customized
Asian
2 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
Race/Ethnicity, Customized
I don't know
0 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
Race/Ethnicity, Customized
White
16 Participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
20 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

Frequency of Patient Log Ins

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

Time frame: 4 Weeks

ArmMeasureValue (MEDIAN)
Intervention ParticipantsFrequency of Patient Log Ins14 log ins to the application per patient
Primary

Frequency of Symptom Survey Completion

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.

Time frame: 4 weeks

ArmMeasureValue (MEDIAN)
Intervention ParticipantsFrequency of Symptom Survey Completion8 completed symptom survey(s) per patient
Secondary

E-scale Acceptability

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.

Time frame: 4 Weeks

ArmMeasureValue (MEAN)Dispersion
Intervention ParticipantsE-scale Acceptability24 score on the acceptability scaleStandard Deviation 4.37
Secondary

Usability

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.

Time frame: 4 Weeks

ArmMeasureValue (MEAN)Dispersion
Intervention ParticipantsUsability78.3 score on the SUS scaleStandard Deviation 16.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026