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Completed

NCT Number: NCT05403801

STAMP+CBT mHealth for Cancer Pain

The purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.

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Key information

Conditions

Active Cancer Active Cancer Treatment Advanced Cancer Chronic Pain Due to Cancer Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

This research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study.

The research study procedures include screening for eligibility, study interventions include surveys at the beginning of the study, after 4 weeks, and after 6 weeks and use of the smartphone app.

Participants will be on this research study for up to 6 weeks.

It is expected that about 15 people will take part in this research study

This research study is a Feasibility Study, which is the first-time investigators are examining this mobile application meant to help participant to learn behavioral techniques to manage cancer pain. The purpose is to make sure the app is usable and helpful for patients with cancer, and to get feedback about patient experiences after using the app for four weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PILOT COHORT
  • Age ≥ 18 years
  • Patients diagnosed with an active cancer diagnosis, either undergoing active cancer treatment or receiving treatment for an advanced cancer or are receiving palliative care
  • Treatment managed at participating clinic (DFCI outpatient palliative care, gastrointestinal cancer center, and DFCI satellite clinic Merrimack Valley or Londonderry)
  • Chronic pain related to cancer or treatment (> pain score of 4)
  • Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
  • Own a compatible smartphone (android) or is willing to use an android device provided by the study team
  • Completes baseline survey

Exclusion criteria

  • Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
  • Cognitive impairment that would interfere with study participation, as judged by treating clinician
  • Inability to speak English: the intervention has not yet been translated to Spanish
  • History of opioid use disorders
  • Enrolled in hospice
  • Currently hospitalized
  • Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS).
  • Pain primarily related to a recent surgery

Treatment and study plan

STAMP+CBT application

Behavioral

Use the STAMP+CBT mobile app for 4 weeks (intervention period, 4 weeks for content introduction, extended 2 weeks for review of content if patient's request this

Primary outcomes

  1. Overall Intervention Adherence Rate

    Time frame: 4 Weeks

    >70% of subjects complete >4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)

  2. Acceptability Rate

    Time frame: 4 weeks

    Participants completed a modified version of the Acceptability E-scale, rating the app on a 5-point Likert scale (1-5), across 5 unique items on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction.[Tariman, 2011] Higher scores indicated greater acceptability. Acceptability was pre-defined as >80% across all acceptability items rated as >4 or higher out of 5. Acceptability was evaluated by determining the mean score of all items for all participants (range of scale of score 1-5).

Secondary outcomes

  1. Number of Enrolled Participants Who Consented and Completed the Study

    Time frame: 7 Months

    Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures.

  2. Study Retention

    Time frame: 6 Months

    The goal of the study was to have 60% of patients who enroll to the app will complete app use (use the app for 28 days) at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment

  3. COMPREHENSIVE ENDPOINT

    Time frame: 6 Weeks

    Overall acceptability will be determined based on composite evaluation of acceptability ratings using the modified items from the Acceptability E-Scale [Tariman 2011]. Participants completed a modified version of the Acceptability e-scale, rating the app on a 5-point Likert scale on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction. Higher scores indicated higher acceptability. Acceptability was pre-defined as >80% of all acceptability items being rated individually as >4 out of 5 (possible scores on this scale range between 1-5). Acceptability was evaluated by determining the mean score on each item individually, across all participants (range of scale of score 1-5).

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Palliative Care Research Center

Registry information

Official study title

Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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