Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain.
The name of the study smartphone application involved in this study is:
-STAMP+CBT
Age ≥ 22 years
Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care
Chronic pain related to cancer or treatment (> pain score of 4 on a 0-10 scale)
Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
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 (e.g. delirium, dementia)
Inability to speak English (the intervention has not yet been translated to Spanish)
Currently in CBT treatment
Parallel
STAMP + CBT
BehavioralA mobile health, smartphone application that provides tailored multi-media, cancer pain psycho-education and pain management coping skills using algorithm-based technology to provide in the moment symptom monitoring and feedback.
Digital Cancer Pain Education Packet
BehavioralPacket including Articles from the Association for Clinical Oncology and the National Cancer Institute and the pain and medication monitoring form.
Overall intervention adherence rate (Cohort C)
\>70% of subjects complete any activity on the STAMP+CBT application at least 50% of days on study (4-week study period). The app will be considered feasible if this benchmark is achieved.
Overall intervention adherence rate (Cohort D)
Defined as completion of the 14- and 28-days surveys, which assesses completion of the pain and medication monitoring reports by participants in the control group.
Proportion of participants who rate app acceptability at least 4/5 on the Acceptability E-Scale (Cohort C)
Acceptability of the intervention is defined as \> 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.
Proportion of participants who rate educational packet acceptability at least 4/5 on the Acceptability E-Scale (Cohort D)
Acceptability of the intervention is defined as \> 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.
Number of Enrolled Participants who Consented and Completed the Study (Cohort C)
Defined as the proportion of participants of the intervention group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
Number of Enrolled Participants who Consented and Completed the Study (Cohort D)
Defined as the proportion of participants of the control group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
Study Retention (Cohort C)
Defined as the proportion of participants of the intervention group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
Study Retention (Cohort D)
Defined as the proportion of participants of the control group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.
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Dana-Farber Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
