Active Cancer, Active Cancer Treatment, Advanced Cancer, Chronic Pain Due to Cancer, Palliative Care
Conditions
Keywords
Active cancer, Active cancer treatment, Advanced Cancer, Palliative care, Chronic Pain due to Cancer
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.
Interventions
BEHAVIORALSTAMP+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
Sponsors
National Palliative Care Research Center
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Intervention Adherence Rate | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Retention | 6 Months | 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 |
| Number of Enrolled Participants Who Consented and Completed the Study | 7 Months | Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures. |
| COMPREHENSIVE ENDPOINT | 6 Weeks | 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). |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from outpatient palliative care clinics
Participants by arm
| Arm | Count |
|---|---|
| Pilot Cohort Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Pilot Cohort |
|---|---|
| Age, Continuous | 52 Years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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).
Time frame: 4 weeks
Population: Evaluate each acceptability items that were rated as 4 or higher out of 5 for all patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Cohort | Acceptability Rate | 4.26 scores on a scale | Standard Deviation 1.07 |
Primary
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)
Time frame: 4 Weeks
Population: Participants who tested the app for 4 weeks (n=8) completed daily their daily EMA surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Cohort | Overall Intervention Adherence Rate | 15.75 EMA App Surveys | Standard Deviation 6.76 |
Secondary
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).
Time frame: 6 Weeks
Population: Patients rated the app's perceived acceptability on understandability, enjoyability, ease of use, time required to use it, and overall satisfaction on a 5-point Likert scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pilot Cohort | COMPREHENSIVE ENDPOINT | Ease of use | 4.29 scores on a scale | Standard Deviation 0.45 |
| Pilot Cohort | COMPREHENSIVE ENDPOINT | Understandability | 5.0 scores on a scale | Standard Deviation 0 |
| Pilot Cohort | COMPREHENSIVE ENDPOINT | Enjoyability | 4.14 scores on a scale | Standard Deviation 0.64 |
| Pilot Cohort | COMPREHENSIVE ENDPOINT | Time acceptability | 4.14 scores on a scale | Standard Deviation 0.99 |
| Pilot Cohort | COMPREHENSIVE ENDPOINT | overall Satisfaction | 4.29 scores on a scale | Standard Deviation 0.45 |
Secondary
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.
Time frame: 7 Months
Population: 10 patients were recruited in 7 months and 8 remained in the study and completed all study activities and measures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilot Cohort | Number of Enrolled Participants Who Consented and Completed the Study | 8 participants |
Secondary
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
Time frame: 6 Months
Population: Percent of patients who consented and also completed 4 weeks of app use and surveys at 4 and 6 weeks after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Cohort | Study Retention | 8 Participants |