Web-Based Intervention for Cancer Pain in Breast Cancer Survivors

(CAI Trial)

Overseen By Wonshik Chee

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Active depression treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based app designed to help breast cancer survivors manage cancer pain and related depressive symptoms. Participants will use either an individualized coaching program or a standard information program, both delivered through the app. The goal is to determine if the personalized approach improves pain and mood more effectively than the standard method. Women who are Chinese, Korean, or Japanese, have been diagnosed with breast cancer in the past, and are currently experiencing cancer pain and depressive symptoms might be suitable candidates. Participants need internet access and should not be undergoing active depression treatment.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for breast cancer survivors.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are in active depression treatment, you will be excluded from the R33 phase of the study.

What prior data suggests that this web-based intervention is safe for breast cancer survivors?

Research shows that the online programs CAI and CAPA help manage cancer pain. These programs deliver information and support through an app. Early studies found that most users handle these apps well, with no major reports of negative effects. While testing and improvements continue, the goal remains to manage pain without adding new risks. This suggests they are safe for managing cancer pain, although individual results may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for cancer pain in breast cancer survivors because they leverage web-based apps to provide personalized coaching and support, offering a novel approach to pain management. Unlike traditional pain therapies that often rely on medications like opioids, these apps focus on individualized coaching, allowing for optimization based on each user's specific needs. This digital delivery method not only broadens accessibility but also empowers patients to manage their pain actively, potentially leading to better outcomes and improved quality of life.

What evidence suggests that this trial's treatments could be effective for cancer pain in breast cancer survivors?

Research has shown that online programs like CAI and CAPA, both studied in this trial, hold promise for managing cancer pain. Early results suggest these programs help by providing personalized information and support, improving pain management and related issues like depression. In this trial, participants in the CAI arm will receive one-on-one coaching tailored to individual needs, potentially increasing effectiveness compared to standard methods. Studies have found these programs to be culturally tailored, enhancing relevance and impact for specific groups, such as Asian American breast cancer survivors. These programs aim to boost users' confidence and belief in their ability to manage cancer pain effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Eun Ok Im

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have felt depressed in the last two weeks.

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)

Exclusion Criteria

I am under 18 years old.

I was diagnosed with breast cancer within the last 5 years.

Those who participated in the PI's pilot studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase - Intervention Development

Development and evaluation of CAI through expert review and usability test

Not specified

Multiple visits for usability testing and expert review

R33 Phase - Randomized Control Trial

Randomized repeated measures control group design to test CAI efficacy

3 months

Pretest, Post 1-month, Post 3-months assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CAI
• CAPA

Trial Overview 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.

How Is the Trial Designed?

Group I: CAI: Web App-based, individualized coaching and support program for cancer pain Experimental Treatment 1 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 pain Active Control 1 Intervention

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

CAI is already approved in United States for the following indications:

Approved in United States as CAI for:

• Cancer pain management
• Depressive symptoms accompanying pain in Asian American breast cancer survivors

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

A tailored web-based intervention for pain management after cardiac surgery was found to be acceptable to 79% of nurses, indicating its potential for improving pain management during early recovery.

While nurses believed the intervention could help patients, they expressed concerns about patient adherence, suggesting that enhancing the intervention's format and customization could improve its effectiveness in preventing chronic postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurses' Perception of a Tailored Web-Based Intervention for the Self-Management of Pain After Cardiac Surgery. Martorella, G., Graven, L., Schluck, G., et al.[2022]

The SOULAGE-TAVIE intervention, a tailored Web-based program for postoperative pain management, was developed and validated through a structured process involving 30 cardiac surgery patients over 4 months, showing high acceptability with 96% of participants finding the strategies helpful.

This innovative approach emphasizes patient empowerment and personalized education, suggesting that using technology can enhance the effectiveness of pain management strategies in a complex healthcare environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SOULAGE-TAVIE: development and validation of a virtual nursing intervention to promote self-management of postoperative pain after cardiac surgery. Martorella, G., Côté, J., Choinière, M.[2022]

Patients with cancer and their caregivers find managing cancer pain at home to be stressful and challenging, primarily due to the unpredictability of pain episodes and their significant impact on daily life, including sleep and social interactions.

The study highlights the need for smart health systems like BESI-C to incorporate user feedback, focusing on passive monitoring of pain and wellness variables, and ensuring functionality for tracking medication intake and its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Experience of Cancer Pain From the Perspective of Patients and Family Caregivers to Inform Design of an In-Home Smart Health System: Multimethod Approach. LeBaron, V., Bennett, R., Alam, R., et al.[2020]

The personalized eHealth intervention for female breast cancer survivors with persistent pain was well-received, being described as easy to use and helpful, indicating strong acceptability and satisfaction among participants.

After 6 weeks of using the program, participants showed significant improvements in pain-related functioning, physical functioning, and quality of life, suggesting the intervention's preliminary efficacy in managing post-surgery pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and pilot testing of a personalized eHealth intervention for pain science education and self-management for breast cancer survivors with persistent pain: a mixed-method study. De Groef, A., Evenepoel, M., Van Dijck, S., et al.[2023]

The e-PainSupport app was successfully enhanced by integrating an evidence-based pain educational intervention and improving usability based on feedback from caregivers and experts, making it easier for them to manage pain in hospice settings.

Despite successful modifications, integrating the app with electronic health records (EHRs) proved to be challenging, highlighting the need for further evaluation of the app's impact on pain management for home hospice patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-PainSupport: A Digital Pain Management Application for Home Hospice Care. Mayahara, M., Wilbur, J., Fogg, L., et al.[2023]

A study involving 115 Asian American breast cancer survivors showed that a technology-based information and coaching program significantly reduced pain and accompanying symptoms over time, particularly in the intervention group.

The intervention group experienced greater decreases in physical symptom distress compared to the control group, indicating that technology-based support can effectively enhance pain management and improve quality of life for these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a technology-based information and coaching/support program on pain and symptoms in Asian American survivors of breast cancer. Im, EO., Kim, S., Yang, YL., et al.[2022]

The combination of multimodal pain rehabilitation (MMR) with the Web Behavior Change Program for Activity (Web-BCPA) significantly reduced catastrophizing in participants with persistent musculoskeletal pain, showing an effect size of 0.61 at 12 months.

Participants who used the Web-BCPA reported higher satisfaction with their rehabilitation program compared to those who only received MMR, indicating that integrating web-based interventions can enhance patient experience in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial. Nordin, CA., Michaelson, P., Gard, G., et al.[2019]

An automated, telephone-based interactive voice response (IVR) intervention significantly reduced moderate to severe pain and improved other cancer-related symptoms in a pilot study involving 60 low-income African American and Latina women with breast cancer.

While the intervention showed effectiveness in managing pain and symptoms, oncologists rated its usefulness for symptom management as only somewhat beneficial, indicating a need for further research on technological approaches in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated pain intervention for underserved minority women with breast cancer. Anderson, KO., Palos, GR., Mendoza, TR., et al.[2022]

The Power Over Pain-Coaching (POP-C) intervention significantly improved functional status and reduced pain-related distress among 310 African American cancer patients, indicating its efficacy in managing cancer pain.

Participants in the POP-C group experienced a notable decrease in pain intensity ratings, particularly in the 'living with pain' aspect, highlighting the intervention's potential to enhance perceived control over pain and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Functional Status in African Americans With Cancer Pain: A Randomized Clinical Trial Hazard Vallerand, A., Hasenau, SM., Robinson-Lane, SG., et al.[2022]

An 8-week web-based pain coping skills training (PCST) program was found to be highly acceptable to cancer patients, providing both emotional and physical benefits, which could improve pain management for those with cancer-related bone pain.

Healthcare providers expressed support for the web-based PCST program, suggesting that it could be effectively integrated into clinical care if barriers such as provider familiarity and patient workload are addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. Rini, C., Vu, MB., Lerner, H., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06085313

Cancer Pain Management Using a Web-based Intervention First, CAI incorporates survivors' own cultural attitudes (deep tailoring) based on the actual data from PSs and uses multiple languages (surface tailoring).

2. reporter.nih.gov reporter.nih.gov/project-details/10595357

Cancer Pain Management Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for ...

3. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R33CA280979

Funded Grants | Division of Cancer Prevention Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/440797

Cancer Pain Management Using a Web-based Intervention Web App-based information and coaching/support program for cancer pain management. Allocation: Randomized. Outcome measures. Primary outcome ...

5. withpower.com withpower.com/trial/phase-breast-neoplasms-3-2024-27f83

Web-Based Intervention for Cancer Pain in Breast ... Trial Overview The study tests a web-based program called CAI designed to manage cancer pain and depression among Asian American breast cancer survivors. It ...

6. formative.jmir.org formative.jmir.org/2024/1/e51021

Support for Chronic Pain Management for Breast Cancer ... This pilot study aims to evaluate patients' experiences, including usability, with a novel digital integrated health ecosystem for chronic pain named ...