Recruiting

Cancer Pain Management

Sponsor:

University of Texas at Austin

Code:

NCT06085313

Conditions

Cancer of Breast

Depressive Symptoms

Cancer Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CAI

CAPA

Study Details

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.

Conditions

Cancer of Breast

Depressive Symptoms

Cancer Pain

Study ID

NCT06085313

Start date

Feb 20, 2024

Status verified date

Jun, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CAI: Web App-based, individualized coaching and support program for cancer pain

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

active comparator: CAPA: Web App-based information and coaching/support program for cancer pain

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

Interventions

CAI

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

CAPA

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

Primary outcome measure

  • Cancer Pain Management (CPM) [ Time Frame: Pretest, Post 1-month, Post 3-months ]
  • Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Pretest, Post 1-month, Post 3-months ]
  • Activity monitoring device (Fitbit) as a tool for digital pain biomarkers [ Time Frame: Pretest, Post 1-month, Post 3-months ]
  • Memorial Symptom Assessment Scale-Short Form (MSAS-SF) [ Time Frame: Pretest, Post 1-month, Post 3-months ]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Pretest, Post 1-month, Post 3-months ]
  • Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) [ Time Frame: Pretest, Post 1-month, Post 3-months ]

Central Contacts and Locations

Locations

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-06-09.