NCT06085313 Cancer Pain Management Using a Web-based Intervention
| NCT ID | NCT06085313 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Cancer of Breast |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-02-20 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * women aged 18 years and older who identify as Chinese, Korean, or Japanese; * have had a breast cancer diagnosis in the past; * can read and write English, Mandarin (simplified or traditional), Korean, or Japanese; * have access to the internet through computers or mobile devices (mobile phones and tablets); * have experienced cancer pain during the past week (at least 1 on a scale from 0 to 5 \[no symptom=0, mild symptom that does not bother=1, somewhat bothering symptom=2, moderate symptom=3, severe symptom=4, and worst possible symptom=5\]); * have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire) which is equivalent to the cut-point of minimal to moderate depression. Exclusion Criteria: * less than 18 years old because their cancer experience would be different from that of adults. * Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past five years, will be excluded. * Those who participated in the PI's pilot studies will be excluded. * The participants of R33 phase will exclude those in active depression treatment regardless of their level of depression. * Those without Internet access will be excluded, but those with Internet access through community/group computers will be included.
Contact & Investigator
Eun Ok Im
PRINCIPAL INVESTIGATOR
The University of Texas at Austin
Frequently Asked Questions
Who can join the NCT06085313 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cancer of Breast. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06085313 currently recruiting?
Yes, NCT06085313 is actively recruiting participants. Contact the research team at cai.help@austin.utexas.edu for enrollment information.
Where is the NCT06085313 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT06085313 clinical trial?
NCT06085313 is sponsored by University of Texas at Austin. The principal investigator is Eun Ok Im at The University of Texas at Austin. The trial plans to enroll 300 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.