Web-Based Intervention for Cancer Pain in Breast Cancer Survivors

(CAI Trial)

Overseen by Eun Ok Im

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Disqualifiers: Active depression treatment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment for cancer pain management in breast cancer survivors?

Research shows that web-based programs, like the one being studied, can help manage cancer pain by providing education and support. For example, a study found that a technology-based program improved pain management and quality of life in Asian American breast cancer survivors. Additionally, web-based pain coping skills training has been found acceptable and potentially beneficial for patients with persistent cancer pain. ^{1 2 3 4 5}

Is the web-based intervention for cancer pain management safe for humans?

The web-based interventions for pain management, including those for cancer pain, have been found to be acceptable and feasible in pilot studies, suggesting they are generally safe for use in humans. ^{1 5 6 7 8}

How is the Web-Based Intervention for Cancer Pain in Breast Cancer Survivors different from other treatments?

This treatment is unique because it uses a web-based platform to provide personalized education and self-management support for pain, focusing on improving understanding and management of pain through technology, which is particularly beneficial for breast cancer survivors who may have limited access to traditional pain management resources. ^{1 2 4 9 10}

Research Team

Eun Ok Im

Principal Investigator

The University of Texas at Austin

Eligibility Criteria

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.

I am a woman, 18 or older, and identify as Chinese, Korean, or Japanese.

Can read and write English, Mandarin (simplified or traditional), Korean, or Japanese

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

Trial Timeline

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

Treatment Details

Interventions

• CAI (Behavioural Intervention)
• CAPA (Behavioural Intervention)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

Findings from Research

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 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]

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 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]

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]

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]

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 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]

References

1. Germany 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Improving Functional Status in African Americans With Cancer Pain: A Randomized Clinical Trial [2022]

3. England 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. [2020]

4. United States 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. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

e-PainSupport: A Digital Pain Management Application for Home Hospice Care. [2023]

7. Canada 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Nurses' Perception of a Tailored Web-Based Intervention for the Self-Management of Pain After Cardiac Surgery. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Automated pain intervention for underserved minority women with breast cancer. [2022]