RecruitingNot ApplicableNCT06085313

Cancer Pain Management Using a Web-based Intervention

Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors


Sponsor

University of Texas at Austin

Enrollment

300 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a web-based program designed to help Asian American women (Chinese, Korean, and Japanese) who have had breast cancer manage cancer-related pain and depressive symptoms. The program is accessible on computers or mobile devices in multiple languages. **You may be eligible if...** - You are a woman aged 18 or older who identifies as Chinese, Korean, or Japanese - You have a history of breast cancer diagnosis - You can read and write in English, Mandarin, Korean, or Japanese - You have internet access through a device or community computer - You have experienced some cancer pain in the past week - You have experienced mild to moderate depressive symptoms in the past two weeks **You may NOT be eligible if...** - You are under 18 years old - Your breast cancer diagnosis was within the past 5 years (whether or not currently in treatment) - You are currently in active treatment for depression - You participated in the researcher's prior pilot studies - You do not have internet access of any kind Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALCAI

Web App-based information and coaching/support program for cancer pain management with additional components for the individual optimization functionality

BEHAVIORALCAPA

Web App-based information and coaching/support program for cancer pain management


Locations(1)

The University of Texas at Austin

Austin, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06085313


Related Trials