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Smartphone Technology to Alleviate Malignant Pain (STAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717402
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Andrea Enzinger, Dana-Farber Cancer Institute

Brief Summary:
This research study is developing and evaluating a new pain management app for cancer patients (STAMP).

Condition or disease Intervention/treatment Phase
Cancer Pain Management Opioid Use Other: STAMP App Other: No access to STAMP App Not Applicable

Detailed Description:

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 project will involve 5 specific activities:

  1. Activity 1 - Content Development (working groups)
  2. Activity 2 - Programming and testing of app algorithms
  3. Activity 3 - User acceptability testing
  4. Activity 4 - Pilot testing
  5. Activity 5 - Patient Qualitative Interviews

Activities 1 and 2 will involve the development of the content and functionalities for the STAMP app. Activity 3 (the user acceptability testing phase of the project) will be conducted to identify and address any problems with the developed tool. User acceptability testing will involve interviews and focus groups with patients and providers who have been shown the app. The information gathered from these interviews and groups will be used to improve the application before it undergoes pilot testing. Activity 4 (pilot testing) will be conducted to demonstrate the utilization and efficacy of the STAMP app among patients with chronic cancer pain and their cancer care providers. Activity 5 (patient qualitative interviews) will be conducted with patients to learn more about their experiences with a cancer diagnosis and chronic pain management.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

This study is being conducted through 5 sequential activities. Activities 3, 4, and 5 all involve human subject participants.

Activity 3 (user acceptability testing) participants will be reported under arm/group 1.

Activity 4 (pilot testing) participants will be reported under arm/group 2.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Activity 3 Participants (UAT)

Activity 3 (User acceptability testing):

  • Patients will utilize the STAMP app in an observed setting.
  • Patients will complete a validated usability survey
  • A series of 6 patients will be video-recorded as they are asked to "think aloud" for 30 minutes as they use STAMP
  • Laboratory UAT will be conducted within the DFCI HCC communications laboratory, among (1) patients using opioids for chronic cancer pain, and (2) oncology providers
Other: STAMP App
STAMP--A patient-facing mobile phone app with a clinician web-based portal aimed to help advanced cancer patients and providers better co-manage cancer pain with opioids.

Activity 4 Participants (Pilot Testing)

Activity 4 (pilot testing):

  • Participants will utilize the STAMP app for 8-weeks.
  • STAMP will prompt patients to complete thrice weekly comprehensive pain assessments
  • will also encourage patients to submit frequent "on-demand" pain ratings - particularly during the first days/weeks of opioid initiation/titration
  • The nurse will review PRO's in the STAMP portal and call patients to discuss symptoms, self-management challenges, assist patients in problem-solving, and offer medical advice
  • The nurse will monitor the STAMP dashboard daily (Mon-Fri), review clinical alerts, contact patients for symptom problems, and confer with oncologists as needed
Other: STAMP App
STAMP--A patient-facing mobile phone app with a clinician web-based portal aimed to help advanced cancer patients and providers better co-manage cancer pain with opioids.

Activity 5 Participants (Patient Qualitative Interviews)

Activity 5 (patient qualitative interviews):

  • Eligible patients will take part in a one-time, 1-hour interview with the study team
  • Up to 30 patients (including DFCI inpatients and outpatients) will be interviewed about their experiences with a cancer diagnosis and chronic pain management.
Other: No access to STAMP App
Patients in this group will not have access to the STAMP app and will take part in a qualitative interview describing their experiences with chronic cancer pain management.




Primary Outcome Measures :
  1. Patients' responses to a usability/acceptability survey as assessed by the Acceptability E-scale (Activity 3 ONLY) [ Time Frame: 1 day (UAT will take place as a one-time user feedback session) ]
    Patients that take part in UAT will complete a validated usability survey (the Acceptability e-Scale) adapted from Tarimian et al. Participants will also respond to open-ended questions about the app. The Acceptability e-Scale includes 6 items: 1) How easy was the app to use?; 2) How much did you enjoy using the app?; 3) How helpful to you was this app in describing your symptoms and QOL?; 4) How would you rate your overall satisfaction with this app?; 5) Was the amount of time it took to complete this app acceptable?; 6) How understandable were the questions? All items offer 5 response options (on a Likert scale of 1 to 5). A response of 1 indicates a negative and a response of 5 indicates a positive evaluation of the app. A score of 3 indicates a neutral response. UAT will occur until no new themes emerge, and the average usability score exceeds 4 (out of 5 on a 5-point Likert scale) for all responses.

  2. Patients' adherence to thrice weekly comprehensive symptom self-assessments (Activity 4 ONLY) [ Time Frame: 8 weeks ]
    Based off app usage, we will calculate patients' overall adherence rate and 95% confidence interval.

  3. Clinicians' adherence to STAMP CDS recommendations (Activity 4 ONLY) [ Time Frame: 8 weeks ]
    Generalized estimating equations (GEE) will estimate overall clinician adherence, accounting for within-clinician correlations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Activity 3 Patient Inclusion Criteria:

  • Patient in the DFCI gastrointestinal cancer center (GCC), breast oncology OR thoracic oncology programs.
  • Age ≥21
  • Diagnosed with metastatic cancer
  • Currently on short and long-acting opioids for cancer pain
  • Own a smartphone.

Activity 3 Clinician Inclusion Criteria:

-Palliative and oncology physicians, mid-level providers, and nurses from across DFCI solid tumor programs

Activity 4 Patient Inclusion Criteria:

  • Patient in the DFCI gastrointestinal cancer center (GCC)
  • Age ≥21
  • Diagnosed with incurable GI cancer
  • Chronic pain rated >4/10 within the last week
  • Have initiated or up-titrated a short and long-acting opioid within the last 2 weeks
  • Own a smartphone.

Activity 4 Clinician Inclusion Criteria:

-Palliative and oncology physicians (and their NPs)

Exclusion Criteria:

Activity 3 Patient Exclusion Criteria:

  • Cognitive impairment
  • Inability to speak English
  • History of substance abuse

Activity 3 Clinician Exclusion Criteria:

-Unwilling to participate

Activity 4 Patient Exclusion Criteria:

  • Cognitive impairment
  • Inability to speak English
  • History of substance abuse
  • Enrolled on hospice
  • Currently hospitalized
  • Use of >300mg oral morphine equivalents per day, or opioids not supported by STAMP (e.g. methadone)
  • Diagnosed with a bowel obstruction
  • The following special populations are excluded: adults unable to consent, prisoners, and pregnant women.

Activity 4 Clinician Exclusion Criteria:

-Unwilling to participate

Activity 5 Patient Inclusion Criteria:

  • Patients diagnosed with a metastatic or locally advanced solid tumor malignancy
  • English-speaking
  • Age ≥21
  • Patient visiting the DFCI outpatient clinic OR Patient admitted to the DFCI inpatient hospital
  • Has chronic pain as the result of cancer
  • Patients prescribed both a short-acting and long-acting opioid

Activity 5 Patient Exclusion Criteria:

  • Long-standing history of chronic pain unrelated to cancer (i.e. arthritis) for which they were taking opioid pain medications before their cancer diagnosis
  • Recent surgical procedure (less than 4 weeks prior) resulting in pain
  • Inability to participate in a 60-90 minute interview, e.g. due to cognitive or physical limitations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717402


Contacts
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Contact: Andrea Enzinger, MD 617-582-7335 andrea_enzinger@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Andrea Enzinger, MD    617-582-7335    andrea_enzinger@dfci.harvard.edu   
Principal Investigator: Andrea Enzinger, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Andrea Enzinger, MD Dana-Farber Cancer Institute

Publications:

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Responsible Party: Andrea Enzinger, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03717402    
Other Study ID Numbers: 18-504
1R21NR017745-01 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Enzinger, Dana-Farber Cancer Institute:
Cancer
Pain management
Opioid use
Health app
Gastrointestinal cancer
Breast cancer
Lung cancer
Additional relevant MeSH terms:
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Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents