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| ID | Type | Description | Link |
|---|---|---|---|
| HM300000094 | Other Identifier | Virginia Commonwealth University | |
| P50MD017319 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This is a feasibility pilot test of a single-arm intervention to evaluate the beta version of an mHealth app-based behavioral intervention prior to scaling for a randomized controlled trial (RCT). This mHealth intervention is designed to enhance self-efficacy and support pain and symptom self-management among post-treatment cancer survivors.
The intervention involves a set of tested intervention messages, ecological momentary assessments (EMAs), and e-diary entries to our PsyMINT mobile app. A 1-week mHealth intervention to cancer survivors who experience pain will be delivered. The feasibility of an mHealth app platform (PsyMINT) as a message presentation environment will be delivered and evaluated. The app messages will target five topics/modules, including psychoeducational materials related to pain management; positive psychology; opioid literacy; skill building for patient-provider communication and trust; and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Health (mHealth) Intervention | Experimental | Implement a bank of 60 mHealth intervention messages, ecological momentary assessments (EMAs), and e-diary entries to PiLR to deliver a 1-week mHealth intervention to cancer survivors experiencing pain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health (mHealth) Intervention | Behavioral | Individuals will use the mHealth app for 1 week. Participants will interact with evidence-based messages and will complete ecological momentary assessments (EMA's) (two times per day) and electronic diaries (e-diaries) daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and acceptability of the mobile health (mHealth) intervention | The feasibility and acceptability of the behavioral intervention will be assessed using a pre-validated measure, the 19-item Post-Study System Usability Questionnaire (PSSUQ)87 (e.g., "It was simple to use this app") on a 7-point Likert scale. Acceptability and feasibility outcomes will be evaluated through analysis of mean scores and proportions, including:
| Baseline and end of one week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy for pain management | Determine preliminary evidence for efficacy, using the 10-item Pain Self-Efficacy Questionnaire (PSEQ) at baseline and at post-intervention. | Baseline and end of one week intervention |
| Improved quality of life using a brief version of the Functional Assessment of Cancer Therapy (FACT-G) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Jung Kim, Ph.D | Contact | 804-628-4688 | sjkim2@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sun Jung Kim, Ph.D | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
There are no plans to share individual data, but a de-identified aggregated form of self-report data may be available to share when the study is complete and findings are published.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D008722 | Methods |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D008919 | Investigative Techniques |
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Determine preliminary evidence of efficacy using a modified version (shortened) of the Functional Assessment of Cancer Therapy (FACT-G) at baseline and post-intervention. The 26-item FACT-G questionnaire is designed to assess 4 domains of health related quality of life in cancer patients: Physical, social, emotional, and functional well-being using a 5-point Likert scale (1 = Not at all through 5=Very much). For the FACT-G questionnaire, difference scores will be calculated for the four subscales and the total score using measurements obtained at baseline and post-intervention. The scoring is designed so that a lower score reflects an improved state of well-being and functioning. |
| Baseline and end of one week intervention |
| Improved Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30) | Determine preliminary evidence of efficacy using the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30) at baseline and at post-intervention. The 30-item EORTC is designed to measure health-related quality of life, including global health status, functional domains (physical, role, emotional, cognitive, and social functioning), and common cancer-related symptoms. We will compute mean scores of these sub-domains which will be reported on a 4 point Likert scale (1= Not at all 4 = Very much). Mean scores for global health status, symptom scales, and functional scales will be computed for measurements assessed at baseline and post-intervention, and difference scores for each subscale will be calculated. Low scores indicate better functioning and improved symptoms. | Baseline and end of one week intervention |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |