Web-based pain coping skills training (PCST) for managing aromatase inhibitor-associated arthralgia in breast cancer survivors: Randomized controlled trial protocol

Zahra Hosseinian; Ashley Lehan; Jessica M. Powers; Adrian Melendez; Hannah M. Fisher; Rebecca Shelby; Tamara Somers; Francis Keefe; Judith Paice; Gretchen Kimmick; James Burns; Ann Marie Flores; Rina S. Fox; Karen Kaiser; David Farrell; Kelly Westbrook; Christine Rini

doi:10.1016/j.cct.2024.107780

Web-based pain coping skills training (PCST) for managing aromatase inhibitor-associated arthralgia in breast cancer survivors: Randomized controlled trial protocol

Zahra Hosseinian, Ashley Lehan, Jessica M. Powers, Adrian Melendez, Hannah M. Fisher, Rebecca Shelby, Tamara Somers, Francis Keefe, Judith Paice, Gretchen Kimmick, James Burns, Ann Marie Flores, Rina S. Fox, Karen Kaiser, David Farrell, Kelly Westbrook, Christine Rini^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia—persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients. Objective: The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia. Methods: 452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life. Discussion: This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.

Original language	English (US)
Article number	107780
Journal	Contemporary Clinical Trials
Volume	149
DOIs	https://doi.org/10.1016/j.cct.2024.107780
State	Published - Feb 2025

Funding

This work was supported by the National Cancer Institute ( R01CA271220 , Rini). The study's funding agency did not have any role in study design; collection, management, analysis, and interpretation of data; writing of the report; nor the decision to submit the report for publication. They do not have ultimate authority over any of these activities. Dr. Jessica Powers was supported by National Cancer Institute ( T32CA193193 , JM Powers).

Keywords

Aromatase inhibitors
Arthralgia
Breast cancer
Cancer pain
Cognitive-behavioral therapy
Digital health
Pain

ASJC Scopus subject areas

Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.cct.2024.107780

Cite this

Hosseinian, Z., Lehan, A., Powers, J. M., Melendez, A., Fisher, H. M., Shelby, R., Somers, T., Keefe, F., Paice, J., Kimmick, G., Burns, J., Flores, A. M., Fox, R. S., Kaiser, K., Farrell, D., Westbrook, K., & Rini, C. (2025). Web-based pain coping skills training (PCST) for managing aromatase inhibitor-associated arthralgia in breast cancer survivors: Randomized controlled trial protocol. Contemporary Clinical Trials, 149, Article 107780. https://doi.org/10.1016/j.cct.2024.107780

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title = "Web-based pain coping skills training (PCST) for managing aromatase inhibitor-associated arthralgia in breast cancer survivors: Randomized controlled trial protocol",

abstract = "Background: Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia—persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients. Objective: The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER{\textregistered}. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia. Methods: 452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life. Discussion: This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.",

keywords = "Aromatase inhibitors, Arthralgia, Breast cancer, Cancer pain, Cognitive-behavioral therapy, Digital health, Pain",

author = "Zahra Hosseinian and Ashley Lehan and Powers, {Jessica M.} and Adrian Melendez and Fisher, {Hannah M.} and Rebecca Shelby and Tamara Somers and Francis Keefe and Judith Paice and Gretchen Kimmick and James Burns and Flores, {Ann Marie} and Fox, {Rina S.} and Karen Kaiser and David Farrell and Kelly Westbrook and Christine Rini",

note = "Publisher Copyright: {\textcopyright} 2024",

year = "2025",

month = feb,

doi = "10.1016/j.cct.2024.107780",

language = "English (US)",

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Hosseinian, Z, Lehan, A, Powers, JM, Melendez, A, Fisher, HM, Shelby, R, Somers, T, Keefe, F, Paice, J, Kimmick, G, Burns, J, Flores, AM, Fox, RS, Kaiser, K, Farrell, D, Westbrook, K & Rini, C 2025, 'Web-based pain coping skills training (PCST) for managing aromatase inhibitor-associated arthralgia in breast cancer survivors: Randomized controlled trial protocol', Contemporary Clinical Trials, vol. 149, 107780. https://doi.org/10.1016/j.cct.2024.107780

TY - JOUR

T1 - Web-based pain coping skills training (PCST) for managing aromatase inhibitor-associated arthralgia in breast cancer survivors

T2 - Randomized controlled trial protocol

AU - Hosseinian, Zahra

AU - Lehan, Ashley

AU - Powers, Jessica M.

AU - Melendez, Adrian

AU - Fisher, Hannah M.

AU - Shelby, Rebecca

AU - Somers, Tamara

AU - Keefe, Francis

AU - Paice, Judith

AU - Kimmick, Gretchen

AU - Burns, James

AU - Flores, Ann Marie

AU - Fox, Rina S.

AU - Kaiser, Karen

AU - Farrell, David

AU - Westbrook, Kelly

AU - Rini, Christine

PY - 2025/2

Y1 - 2025/2

N2 - Background: Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia—persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients. Objective: The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia. Methods: 452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life. Discussion: This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.

AB - Background: Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia—persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients. Objective: The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia. Methods: 452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life. Discussion: This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.

KW - Aromatase inhibitors

KW - Arthralgia

KW - Breast cancer

KW - Cancer pain

KW - Cognitive-behavioral therapy

KW - Digital health

KW - Pain

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Web-based pain coping skills training (PCST) for managing aromatase inhibitor-associated arthralgia in breast cancer survivors: Randomized controlled trial protocol

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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