STAMP+CBT mHealth for Cancer Pain

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403801
• Other study ID #: 21-719
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Dana-Farber Cancer Institute
• Contact: Desiree Azizoddin, PsyD
• Phone: (626) 826-7984
• Email: Desiree_Azizoddin[@]DFCI.Harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Active Cancer
• Advanced Cancer
• Chronic Pain
• Palliative Care

Intervention

Behavioral:
• STAMP+CBT application
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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber at Londonderry	Londonderry	New Hampshire
United States	Dana-Farber at Merrimack Valley	Methuen	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Palliative Care Research Center (NPCRC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Intervention Adherence Rate	>70% of subjects complete >4 of the 6 pain-CBT modules and patients will complete 60% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)(completion of the 4-week intervention study period)	4 Weeks
Primary	Acceptability Rate	>80% of the acceptability items are rated 4 or higher/5; lower ratings will lead to app refinements	4 weeks
Secondary	Study Accrual Rate	15 patients will be enrolled to the trial within 6 months	6 Months
Secondary	Study retention	60% of patients who enroll to the app with complete app use at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment	6 Months
Secondary	COMPREHENSIVE ENDPOINT	Overall acceptability will be determined based on composite evaluation of acceptability ratings using the e-Acceptability scale, app content completion rates, and qualitative patient feedback.	6 Weeks