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Cancer Pain Management Using a Web-based Intervention

Study acronym: CAI
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 2 versions Re-verified since Sep 8, 2025, no change to tracked fieldsv6-v7
  2. Minor Site contact updated
    • Eligibility criteria shortened, about 2 words
    v5
  3. Notable Primary completion date: Sep 15, 2026 to Aug 31, 2027
    • Study completion date: Aug 31, 2028 to Aug 31, 2027
    • Eligibility criteria revised
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 15, 2024 to Feb 20, 2024
    v3
  5. Notable Primary endpoints revised (6)
    • Study description expanded, about 11 words
    • Eligibility criteria shortened, about 1 word
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.
Trial Details
NCT Number NCT06085313
Lead Sponsor University of Texas at Austin
Conditions
(from sponsor)
Cancer of Breast, Depressive Symptoms, Cancer Pain
Related terms Breast Neoplasms, Cancer Pain, Depression
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov