NCT06085313: CAI

Cancer Pain Management Using a Web-based Intervention

Recruiting now NA Last updated 15 September 2025

What this trial tests

NA trial testing CAI in Cancer of Breast in 300 participants. Currently enrolling.

Timeline

20 February 2024

Primary endpoint
31 August 2027

31 August 2027

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	20 February 2024
Primary completion	31 August 2027
Estimated completion	31 August 2027
Sites	1 location across United States

Drugs / interventions tested

• CAI
• CAPA

Conditions studied

• Cancer of Breast — all drugs for Cancer of Breast →
• Depressive Symptoms — all drugs for Depressive Symptoms →
• Cancer Pain — all drugs for Cancer Pain →

Sponsor

University of Texas at Austin

Who can join

18 and older, female only, with Cancer of Breast or Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.