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Behavioural Intervention

Web-Based Intervention for Cancer Pain in Breast Cancer Survivors (CAI Trial)

N/A
Recruiting
Led By Eun Ok Im
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Women aged 18 years and older who identify as Chinese, Korean, or Japanese
Must not have
Less than 18 years old
Participants of R33 phase will exclude those in active depression treatment regardless of their level of depression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pretest, post 1-month, post 3-months
Awards & highlights

Summary

This trial aims to develop a web-based program called CAI to help Asian American breast cancer survivors manage cancer pain. The program will be tailored to individuals and will also address depressive symptoms. The study will

Who is the study for?
This trial is for women over 18 who identify as Chinese, Korean, or Japanese; can read and write English or their native languages; have internet access; experienced cancer pain in the past week and depressive symptoms in the last two weeks. They must also have been diagnosed with breast cancer within the last five years.
What is being tested?
The study tests a web-based program called CAI designed to manage cancer pain and depression among Asian American breast cancer survivors. It compares improvements between those using CAI plus usual care versus an active control group using CAPA (a previous version) plus usual care.
What are the potential side effects?
Since this intervention involves a web-based application for managing pain and depression, traditional medication side effects are not applicable. However, users may experience discomfort if they find navigating the app challenging or if it does not effectively address their pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have felt depressed in the last two weeks.
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I am a woman, 18 or older, and identify as Chinese, Korean, or Japanese.
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I was diagnosed with breast cancer within the last 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
Select...
I am not currently receiving treatment for depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pretest, post 1-month, post 3-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pretest, post 1-month, post 3-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Activity monitoring device (Fitbit) as a tool for digital pain biomarkers
Brief Pain Inventory-Short Form (BPI-SF)
Cancer Pain Management (CPM)
+3 more
Secondary study objectives
Acculturation Stress Scale (ASS)
Cancer Behavior Inventory (CBI)
Discrimination Scale (DS)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CAI: Web App-based, individualized coaching and support program for cancer painExperimental Treatment1 Intervention
Web App-based information and coaching/support program for cancer pain management with the individual optimization functionality
Group II: CAPA: Web App-based information and coaching/support program for cancer painActive Control1 Intervention
Web App-based information and coaching/support program for cancer pain management

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
370 Previous Clinical Trials
82,886 Total Patients Enrolled
Eun Ok ImPrincipal InvestigatorThe University of Texas at Austin
~200 spots leftby Aug 2027
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