RECRUITING

Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia

Conditions

Breast Cancer Arthralgia Pain, Chronic Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are: 1. Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives. 2. Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications. 3. Whether benefits of online pain coping skills training are at least partially caused by women's increased confidence that they can manage their pain and a reduction in unhelpful thinking patterns about pain. 4. Whether online pain coping skills training improves effects of AI medications on sleep problems and symptoms of menopause like hot flashes and night sweats. Participants can complete all parts of the study at home. They will: 1. Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months. 2. Attend 3 meetings in the first month of the study, all of which can be held via a video conference. 3. Use an electronic pill bottle to track their use of their AI medication. 4. Be randomized (like flipping a coin) to one of two study arms: They will either receive education about AIs and arthralgia or they will receive this education along with access to an online pain coping skills training program. Research will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.

Official Title

Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial

Quick Facts

Study Start:2023-01-19

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05703178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Female sex * Aged 18 years old or older * Diagnosed with Stage I-III hormone receptor positive breast cancer * Completed primary cancer treatment (surgery, chemotherapy, and/or radiation therapy) * Postmenopausal * Currently taking AI therapy (letrozole, exemestane, or anastrozole) * Reporting musculoskeletal pain that developed or worsened since starting AI therapy * Reporting at least 15 days of pain in the past 30 days * A worst pain rating of 4 or more on an 11 point (0-10) numerical rating scale in the past week * Based on known factors affecting their prognosis, patient is likely to be able to complete the study protocol * ECOG performance status of 0-2 * English proficient * If participants are taking analgesics, they must be on a stable analgesic regimen for at least 14 days prior to enrollment and should not have planned upward dose titration of their analgesics during the study period. (Note: Patients may elect to decrease their analgesic use during the study as per discussion with their provider. Unexpected dose adjustments including dose escalations due to unforeseen clinical need is allowed. Cannabis taken for pain relief would qualify as an analgesic) * Comfortable using a tablet computer, a computer, or a smartphone to access online training	* Evidence of metastatic disease * Other active cancer (with the exception of non-melanoma skin cancer) * Completed chemotherapy or radiation therapy less than four weeks prior to enrollment (these treatments can cause temporary exacerbation of musculoskeletal symptoms that typically resolve spontaneously) * Completed surgery less than 8 weeks prior to enrollment (because surgery can cause temporary post-surgical pain that typically resolves in this period of time); minor surgeries may be allowed more recently than 8 weeks at the discretion of the study team * Have diagnosed or suspected condition that would interfere with informed consent or completion of study activities (e.g., significant impairment in cognition or uncorrected hearing/vision)

Inclusion Criteria

Exclusion Criteria

* Female sex
* Aged 18 years old or older
* Diagnosed with Stage I-III hormone receptor positive breast cancer
* Completed primary cancer treatment (surgery, chemotherapy, and/or radiation therapy)
* Postmenopausal
* Currently taking AI therapy (letrozole, exemestane, or anastrozole)
* Reporting musculoskeletal pain that developed or worsened since starting AI therapy
* Reporting at least 15 days of pain in the past 30 days
* A worst pain rating of 4 or more on an 11 point (0-10) numerical rating scale in the past week
* Based on known factors affecting their prognosis, patient is likely to be able to complete the study protocol
* ECOG performance status of 0-2
* English proficient
* If participants are taking analgesics, they must be on a stable analgesic regimen for at least 14 days prior to enrollment and should not have planned upward dose titration of their analgesics during the study period. (Note: Patients may elect to decrease their analgesic use during the study as per discussion with their provider. Unexpected dose adjustments including dose escalations due to unforeseen clinical need is allowed. Cannabis taken for pain relief would qualify as an analgesic)
* Comfortable using a tablet computer, a computer, or a smartphone to access online training

* Evidence of metastatic disease
* Other active cancer (with the exception of non-melanoma skin cancer)
* Completed chemotherapy or radiation therapy less than four weeks prior to enrollment (these treatments can cause temporary exacerbation of musculoskeletal symptoms that typically resolve spontaneously)
* Completed surgery less than 8 weeks prior to enrollment (because surgery can cause temporary post-surgical pain that typically resolves in this period of time); minor surgeries may be allowed more recently than 8 weeks at the discretion of the study team
* Have diagnosed or suspected condition that would interfere with informed consent or completion of study activities (e.g., significant impairment in cognition or uncorrected hearing/vision)

Contacts and Locations

Study Contact

Christine Rini, PhD

CONTACT

312-503-7715

christine.rini@northwestern.edu

Zahra Hosseinian

CONTACT

Zahra.Hosseinian@northwestern.edu

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Duke University

Durham, North Carolina, 27708

United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-19

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2023-01-19

Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments

Additional Relevant MeSH Terms

Breast Cancer
Arthralgia
Pain, Chronic