Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers
- Conditions
- Registration Number
- NCT06722014
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
Smartphone Technology to Alleviate Malignant Pain (STAMP) The purpose of the study is to develop and refine the Smartphone Technology to Alleviate Malignant Pain (STAMP) application intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for ad...
- Detailed Description
The purpose of the study is to make sure the app is usable and helpful for participants with cancer and to get feedback about participants experiences after using the app for four weeks. Outcomes related to pain, quality of life, and healthcare utilization will also be assessed. The cancer pain education packet and pain and medication monitoring survey are s...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 83
- 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)
- Own/use a compatible smartphone (iPhone or Android)
- 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
- 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 (within the last 2 weeks)
- Conditions that hinder smartphone use
- The study will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Completion Rate of App-Delivered Content (Cohort C) Up to 6 weeks The STAMP+CBT application will be considered feasible if \>70% of participants complete any activity on the app at least 50% of the days on study.
Retention Rate (Cohort C) Up to 6 weeks Defined as the proportion of participants of the intervention group on study for the complete study period.
Retention Rate (Cohort D) Up to 6 weeks Defined as the proportion of participants of the control group on study for the complete study period.
Survey Completion Rate (Cohort D) Days 14 and 28 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.
Application Utilization Time (Cohort C) Up to 6 Weeks Defined as the amount of time a participant spends on the STAMP+CBT application per day per week.
Time to Accrual Participation Rate (Cohort C) Up to 12 months, based on total accrual duration Defined as the proportion of enrolled participants to the amount of time until enrollment from the formal activation of the study.
Time to Accrual Participation Rate (Cohort D) Up to 12 months, based on total accrual duration Defined as the proportion of enrolled participants to the amount of time until enrollment from the formal activation of the study.
- Secondary Outcome Measures
Name Time Method Change in System Usability Scale (SUS) Score from Baseline to Week 4 (Cohort C) Baseline and Week 4 Intervention usability will be assessed by the System Usability Scale (SUS), a 12-item measure rated on a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree" with a total scores range of 0 to 100. A higher score represents greater usability.
Change in SUS Score from Baseline to Week 6 (Cohort C) Baseline and Week 6 Intervention usability will be assessed by the System Usability Scale (SUS), a 12-item measure rated on a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree" with a total scores range of 0 to 100. A higher score represents greater usability.
Change in Acceptability E-Scale Score from Baseline to 4 Weeks (Cohort C) Baseline and Week 4 Acceptability of the intervention is defined as \> 80% of the participants rate the application as satisfactory and useful with a 4 or higher score out of 5 on the Acceptability E-Scale. 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...
Change in Acceptability E-Scale Score from Baseline to 6 Weeks (Cohort C) Baseline and Week 6 Acceptability of the intervention is defined as \> 80% of the participants rate the application as satisfactory and useful with a 4 or higher score out of 5 on the Acceptability E-Scale. 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...
Change in Acceptability E-Scale Score from Baseline to 4 Weeks (Cohort D) Baseline and Week 4 Acceptability of the digital educational packet is defined as \> 80% of the participants rate the packet as satisfactory and useful with a 4 or higher score out of 5 on the Acceptability E-Scale. 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 us...
Change in Acceptability E-Scale Score from Baseline to 6 Weeks (Cohort D) Baseline and Week 6 Acceptability of the digital educational packet is defined as \> 80% of the participants rate the packet as satisfactory and useful with a 4 or higher score out of 5 on the Acceptability E-Scale. 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 us...
Change in Functional Assessment of Cancer Therapy- General (FACT-G) Scale Score from Baseline to 4 Weeks (Cohort C) Baseline and 4 Weeks Assessed by the FACT-G, a 27-item measure on health-related quality of life domains during the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. A higher score indicates better quality of life.
Change in FACT-G Scale Score from Baseline to 6 Weeks (Cohort C) Baseline and 6 Weeks Assessed by the FACT-G, a 27-item measure on health-related quality of life domains during the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. A higher score indicates better quality of life.
Change in FACT-G Scale Score from Baseline to 4 Weeks (Cohort D) Baseline and 4 Weeks Assessed by the FACT-G, a 27-item measure on health-related quality of life domains during the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. A higher score indicates better quality of life.
Change in FACT-G Scale Score from Baseline to 6 Weeks (Cohort D) Baseline and 6 Weeks Assessed by the FACT-G, a 27-item measure on health-related quality of life domains during the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. A higher score indicates better quality of life.
Change in Pain Catastrophizing Scale (PCS) Score from Baseline to 4 weeks (Cohort C) Baseline and 4 Weeks Assessed by the Pain Catastrophizing Scale (PCS), a 13-item measure with answers scored using a 5-point Likert scale ranging from 0 (never) to 4 (all the time). A total scores range is 0 to 52 with a higher score reflecting higher levels of catastrophic thoughts.
Change in PCS Score from Baseline to 6 weeks (Cohort C) Baseline and 6 Weeks Assessed by the Pain Catastrophizing Scale (PCS), a 13-item measure with answers scored using a 5-point Likert scale ranging from 0 (never) to 4 (all the time). A total scores range is 0 to 52 with a higher score reflecting higher levels of catastrophic thoughts.
Change in PCS Score from Baseline to 4 weeks (Cohort D) Baseline and 4 Weeks Assessed by the Pain Catastrophizing Scale (PCS), a 13-item measure with answers scored using a 5-point Likert scale ranging from 0 (never) to 4 (all the time). A total scores range is 0 to 52 with a higher score reflecting higher levels of catastrophic thoughts.
Change in PCS Score from Baseline to 6 weeks (Cohort D) Baseline and 6 Weeks Assessed by the Pain Catastrophizing Scale (PCS), a 13-item measure with answers scored using a 5-point Likert scale ranging from 0 (never) to 4 (all the time). A total scores range is 0 to 52 with a higher score reflecting higher levels of catastrophic thoughts.
Change in Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to 4 Weeks (Cohort C) Baseline and 4 Weeks Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Change in HADS Anxiety Subscale Score from Baseline to 6 Weeks (Cohort C) Baseline and 6 Weeks Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Change in HADS Depression Subscale Score from Baseline to 4 Weeks (Cohort D) Baseline and 4 Weeks Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Change in HADS Depression Subscale Score from Baseline to 6 Weeks (Cohort D) Baseline and 6 Weeks Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Change in the Short Form Perceived Stress Scale (PSS-4) Score from Baseline to 4 Weeks (Cohort C) Baseline and 4 Weeks Assessed by the PSS, a 4-item measure with answers scored on a 5-point Likert scale of 0 "Never" to 4 "Very Often." A total scores range is 0 to 16 with a higher score indicating greater perceived stress.
Change in PSS-4 Score from Baseline to 6 Weeks (Cohort C) Baseline and 6 Weeks Assessed by the PSS, a 4-item measure with answers scored on a 5-point Likert scale of 0 "Never" to 4 "Very Often." A total scores range is 0 to 16 with a higher score indicating greater perceived stress.
Change in PSS-4 Score from Baseline to 4 Weeks (Cohort D) Baseline and 4 Weeks Assessed by the PSS, a 4-item measure with answers scored on a 5-point Likert scale of 0 "Never" to 4 "Very Often." A total scores range is 0 to 16 with a higher score indicating greater perceived stress.
Change in PSS-4 Score from Baseline to 6 Weeks (Cohort D) Baseline and 6 Weeks Assessed by the PSS, a 4-item measure with answers scored on a 5-point Likert scale of 0 "Never" to 4 "Very Often." A total scores range is 0 to 16 with a higher score indicating greater perceived stress.
Change in Pain Self- Efficacy (PSEQ) Questionnaire Score from Baseline to 4 Weeks (Cohort C) Baseline and 4 Weeks Assessed by the PSEQ, an 8-item measure on self- efficacy in pain management with answers scored on a scale from 0 "Not at all confident" to 6 "Completely confident." A total scores range is 0 to 48 with a higher score indicating greater self-efficacy.
Change in PSEQ Score from Baseline to 6 Weeks (Cohort C) Baseline and 6 Weeks Assessed by the PSEQ, an 8-item measure on self- efficacy in pain management with answers scored on a scale from 0 "Not at all confident" to 6 "Completely confident." A total scores range is 0 to 48 with a higher score indicating greater self-efficacy.
Change in PSEQ Questionnaire Score from Baseline to 4 Weeks (Cohort D) Baseline and 4 Weeks Assessed by the PSEQ, an 8-item measure on self- efficacy in pain management with answers scored on a scale from 0 "Not at all confident" to 6 "Completely confident." A total scores range is 0 to 48 with a higher score indicating greater self-efficacy.
Change in PSEQ Questionnaire Score from Baseline to 6 Weeks (Cohort D) Baseline and 6 Weeks Assessed by the PSEQ, an 8-item measure on self- efficacy in pain management with answers scored on a scale from 0 "Not at all confident" to 6 "Completely confident." A total scores range is 0 to 48 with a higher score indicating greater self-efficacy.
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States