Clinical trial NCT05403801: STAMP+CBT mHealth for Cancer Pain
Official title: Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Active Cancer
Active Cancer Treatment
Advanced Cancer
Palliative Care
Chronic Pain Due to Cancer
Keywords: Active cancer
Active cancer treatment
Advanced Cancer
Palliative care
Chronic Pain due to Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Palliative Care Research Center
First posted: 2022-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Intervention Adherence Rate
timeFrame: 4 Weeks
measure: Acceptability Rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Enrolled Participants Who Consented and Completed the Study
timeFrame: 7 Months
measure: Study Retention
timeFrame: 6 Months
measure: COMPREHENSIVE ENDPOINT
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Methuen
country: United States
facility: Dana-Farber at Merrimack Valley
state: Massachusetts
city: Londonderry
country: United States
facility: Dana-Farber at Londonderry
state: New Hampshire
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Desiree Azizoddin, PsyD
role: PRINCIPAL_INVESTIGATOR
References: