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NCT06085313 · ClinicalTrials.gov registry record · NA
Cancer Pain Management Using a Web-based Intervention
A NA study of Depressive Symptoms and Cancer Pain, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT06085313 is a NA study of Depressive Symptoms and Cancer Pain that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 300 participants, above the 257-participant average among 60 other Depressive Symptoms trials with a reported enrollment target (17% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06085313, a NA study of Depressive Symptoms and Cancer Pain, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is funded by the HEAL Initiative (https://heal.nih.gov/). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. L
Conditions Studied
Interventions
- BEHAVIORAL CAI
- BEHAVIORAL CAPA
Study Locations (1)
Texas
- The University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-02-20 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06085313
The ClinicalTrials.gov registry entry for NCT06085313 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 257-participant average among 60 other Depressive Symptoms trials with a reported enrollment target (17% higher). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Depressive Symptoms appearing as the primary indexed condition, and to 2 interventions - of which CAI is the first listed.
NCT06085313 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06085313 about?
NCT06085313 is a clinical study titled "Cancer Pain Management Using a Web-based Intervention". This study is funded by the HEAL Initiative (https://heal.nih.gov/). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for cancer pain management (CAPA) that was culturally tailored to Asian Ameri...
What is the current status of trial NCT06085313?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2024-02-20. Estimated completion is 2027-08-31.
What conditions does trial NCT06085313 study?
This clinical trial studies the following conditions: Depressive Symptoms, Cancer Pain, Cancer of Breast.
What interventions are being tested in trial NCT06085313?
The interventions under investigation include: CAI (BEHAVIORAL), CAPA (BEHAVIORAL).
Who is sponsoring clinical trial NCT06085313?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06085313 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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