Active CancerNCT05403801
STAMP+CBT mHealth for Cancer Pain
A study testing STAMP+CBT application in people with Active Cancer and Active Cancer Treatment, run by Dana-Farber Cancer Institute at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Cancer, Active Cancer Treatment, Advanced Cancer
- What is being tested?
- STAMP+CBT application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2022to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber at Londonderry
Londonderry, New Hampshire, 03053
Dana-Farber at Merrimack Valley
Methuen, Massachusetts, 01844
About this study
Official title: Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain
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.
Read the 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.
- Conditions
- Active Cancer, Active Cancer Treatment, Advanced Cancer, Palliative Care, Chronic Pain Due to Cancer
- Being tested
- STAMP+CBT application
- Keywords
- Active cancer, Active cancer treatment, Advanced Cancer, Palliative care, Chronic Pain due to Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAMP+CBT applicationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| STAMP+CBT PILOT | Experimental | 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). Receives: Behavioral: STAMP+CBT application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Intervention Adherence Rate
>70% of subjects complete >4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)
Measured: 4 Weeks
Acceptability Rate
Participants completed a modified version of the Acceptability E-scale, rating the app on a 5-point Likert scale (1-5), across 5 unique items on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction.[Tariman, 2011] Higher scores indicated greater acceptability. Acceptability was pre-defined as >80% across all acceptability items rated as >4 or higher out of 5. Acceptability was evaluated by determining the mean score of all items for all participants (range of scale of score 1-5).
Measured: 4 weeks
Secondary outcomes (3)
Number of Enrolled Participants Who Consented and Completed the Study
Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures.
Measured: 7 Months
Study Retention
The goal of the study was to have 60% of patients who enroll to the app will complete app use (use the app for 28 days) at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment
Measured: 6 Months
COMPREHENSIVE ENDPOINT
Overall acceptability will be determined based on composite evaluation of acceptability ratings using the modified items from the Acceptability E-Scale [Tariman 2011]. Participants completed a modified version of the Acceptability e-scale, rating the app on a 5-point Likert scale on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction. Higher scores indicated higher acceptability. Acceptability was pre-defined as >80% of all acceptability items being rated individually as >4 out of 5 (possible scores on this scale range between 1-5). Acceptability was evaluated by determining the mean score on each item individually, across all participants (range of scale of score 1-5).
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jul 2022
- Primary completion8 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Active CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Palliative Care Research Center
- Responsible party
- Principal investigator, Desiree R. Azizoddin PsyD, Dana-Farber Cancer Institute
- Investigators
- Desiree Azizoddin, PsyD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403801
- Sponsor's protocol ID
- 21-719
- Status last verified
- Nov 2024
- First submitted
- 26 May 2022
- Last updated
- 1 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Azizoddin DR, DeForge SM, Baltazar A, Edwards RR, Allsop M, Tulsky JA, Businelle MS, Schreiber KL, Enzinger AC. Development and pre-pilot testing of STAMP + CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain. Support Care Cancer. 2024 Jan 22;32(2):123. doi: 10.1007/s00520-024-08307-7.
PubMed 38252172
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain
- ClinicalTrials.gov ID
- NCT05403801
- Acronym / sponsor ID
- 21-719
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Palliative Care Research Center
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Posted 1 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STAMP+CBT PILOT | Experimental | Behavioral: STAMP+CBT applicationPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAMP+CBT applicationUse 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 | Behavioural | STAMP+CBT PILOT |
Primary outcome
Overall Intervention Adherence Rate
Time frame: 4 Weeks
>70% of subjects complete >4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)
Acceptability Rate
Time frame: 4 weeks
Participants completed a modified version of the Acceptability E-scale, rating the app on a 5-point Likert scale (1-5), across 5 unique items on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction.[Tariman, 2011] Higher scores indicated greater acceptability. Acceptability was pre-defined as >80% across all acceptability items rated as >4 or higher out of 5. Acceptability was evaluated by determining the mean score of all items for all participants (range of scale of score 1-5).
3 secondary outcomes
Number of Enrolled Participants Who Consented and Completed the Study
Time frame: 7 Months
Study Retention
Time frame: 6 Months
COMPREHENSIVE ENDPOINT
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38252172Azizoddin DR, DeForge SM, Baltazar A, Edwards RR, Allsop M, Tulsky JA, Businelle MS, Schreiber KL, Enzinger AC. Development and pre-pilot testing of STAMP + CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain. Support Care Cancer. 2024 Jan 22;32(2):123. doi: 10.1007/s00520-024-08307-7.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desiree Azizoddin, PsyD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAMP+CBT application in people with Active Cancer and Active Cancer Treatment, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Intervention Adherence Rate (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.