STAMP+CBT mHealth for Cancer Pain

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Advanced Cancer; Active Cancer Treatment; Active Cancer; Chronic Pain Due to Cancer; Palliative Care

Treatments: Behavioral: STAMP+CBT application

Study type: Interventional

Funder types: Other

Identifiers

NCT05403801

21-719

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

STAMP+CBT PILOT

Experimental group

Description:

Patients in this Pilot Cohort will be in the research study for 6 weeks total including: * a 4-week intervention period and 2-week post intervention period. * Patients will use the app for a total of 4 weeks (4-week intervention period), and will complete surveys at baseline, 4 weeks (end of intervention period), and at 6 weeks (end of 2-week post intervention period).

Treatment:

Behavioral: STAMP+CBT application