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STAMP+CBT mHealth for Cancer Pain

Primary Purpose

Active Cancer, Active Cancer Treatment, Advanced Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAMP+CBT application
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Active Cancer focused on measuring Active cancer, Active cancer treatment, Advanced Cancer, Palliative care, Chronic Pain due to Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting
  • Dana-Farber at Merrimack ValleyRecruiting
  • Dana-Farber at Londonderry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STAMP+CBT PILOT

Arm 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).

Outcomes

Primary Outcome Measures

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)
Acceptability Rate
>80% of the acceptability items are rated 4 or higher/5; lower ratings will lead to app refinements

Secondary Outcome Measures

Study Accrual Rate
15 patients will be enrolled to the trial within 6 months
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
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.

Full Information

First Posted
May 26, 2022
Last Updated
November 17, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Palliative Care Research Center (NPCRC)
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1. Study Identification

Unique Protocol Identification Number
NCT05403801
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Palliative Care Research Center (NPCRC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STAMP+CBT PILOT
Arm Type
Experimental
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
STAMP+CBT application
Intervention Description
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 Outcome Measure Information:
Title
Overall Intervention Adherence Rate
Description
>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)
Time Frame
4 Weeks
Title
Acceptability Rate
Description
>80% of the acceptability items are rated 4 or higher/5; lower ratings will lead to app refinements
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Study Accrual Rate
Description
15 patients will be enrolled to the trial within 6 months
Time Frame
6 Months
Title
Study retention
Description
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
Time Frame
6 Months
Title
COMPREHENSIVE ENDPOINT
Description
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.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Desiree Azizoddin, PsyD
Phone
(626) 826-7984
Email
Desiree_Azizoddin@DFCI.Harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desiree Azizoddin, PsyD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desiree R Azizoddin, PsyD
First Name & Middle Initial & Last Name & Degree
Desiree R Azizoddin, PsyD
Facility Name
Dana-Farber at Merrimack Valley
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick Briccetti, MD
First Name & Middle Initial & Last Name & Degree
Frederick Briccetti, MD
Facility Name
Dana-Farber at Londonderry
City
Londonderry
State/Province
New Hampshire
ZIP/Postal Code
03053
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Sanz-Altamira, MD
First Name & Middle Initial & Last Name & Degree
Pedro Sanz-Altamira, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

STAMP+CBT mHealth for Cancer Pain

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