STAMP+CBT mHealth for Cancer Pain

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05403801

Collaborator

National Palliative Care Research Center (NPCRC) (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Active Cancer Active Cancer Treatment Advanced Cancer Palliative Care Chronic Pain Due to Cancer	Behavioral: STAMP+CBT application	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STAMP+CBT PILOT 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).	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

Arm

Intervention/Treatment

Experimental: STAMP+CBT PILOT

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).

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

Outcome Measures

Primary Outcome Measures

Overall Intervention Adherence Rate [4 Weeks]
>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)
Acceptability Rate [4 weeks]
>80% of the acceptability items are rated 4 or higher/5; lower ratings will lead to app refinements

Secondary Outcome Measures

Study Accrual Rate [6 Months]
15 patients will be enrolled to the trial within 6 months
Study retention [6 Months]
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
COMPREHENSIVE ENDPOINT [6 Weeks]
Patients self-report of the app acceptability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
2	Dana-Farber at Merrimack Valley	Methuen	Massachusetts	United States	01844
3	Dana-Farber at Londonderry	Londonderry	New Hampshire	United States	03053