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Breast CancerPhase 3NCT05703178

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

A Phase 3 study testing Online Pain Coping Skills Training and Education in people with Breast Cancer and Arthralgia, run by Northwestern University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Arthralgia, Pain, Chronic
What is being tested?
Online Pain Coping Skills Training and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
2 sitesUnited States
Study dates
19 Jan 2023to 1 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female sex
  • Aged 18 years old or older
  • Diagnosed with Stage 0-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)
Show all 14Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Duke University

    Durham, North Carolina, 27708

Other trials in United States

About this study

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

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.
Read more

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.

Being tested
Online Pain Coping Skills Training, Education
Keywords
Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments
Medical subject headings
Breast Neoplasms, Arthralgia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Pain Coping Skills TrainingBehavioural

    The intervention is completed online, using a personal computer, tablet computer, or smartphone. It includes 8 interactive sessions, each of which teaches users a different pain coping skill. Participants are asked to practice these skills in their daily lives to manage pain and pain-related symptoms and problems. Each session takes 35 to 45 minutes to complete. Participants can take breaks during the sessions and review them at any time after completing them.

  • EducationOther

    Participants will receive their usual medical care and an educational booklet with information about Aromatase Inhibitors (AIs), side effects they cause including painful arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other AI side effects.

Study groups in NCT05703178
Study groupRoleWhat they receive
Education + Online Pain Coping Skill TrainingExperimentalParticipants will receive their usual medical care and an educational booklet with information about Aromatase Inhibitors (AIs), side effects they cause including painful arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other AI side effects. They will also be given access to an online pain coping skills training program and asked to complete it at home over 8 to 10 weeks. This interactive, web-based program teaches cognitive and behavioral skills that research has shown can reduce pain and pain-related interference with daily activities. The program includes eight sessions that participants will complete at a rate of about 1 per week. Each session takes 35-45 minutes. Participants will be shown how to use the program and can contact the study team if they have any problems with it. Participants who do not have a device capable of accessing the program will be loaned a tablet computer for the study.
Receives: Behavioral: Online Pain Coping Skills Training; Other: Education
EducationActive comparatorParticipants will receive their usual medical care and an educational booklet with information about Aromatase Inhibitors (AIs), side effects they cause including painful arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other AI side effects.
Receives: Other: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brief Pain Inventory pain severity subscale

    We will calculate the mean of the four items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate more severe pain. Analyses will examine group differences in change in pain severity.

    Measured: Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)

  2. Change in Brief Pain Inventory pain interference subscale

    We will calculate the mean of the seven items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate greater interference. Analyses will examine group differences in change in pain interference.

    Measured: Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)

Secondary outcomes (15)

  1. Change in Brief Pain Inventory pain severity subscale

    We will calculate the mean of the four items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate more severe pain. Analyses will examine group differences in change in pain severity.

    Measured: Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)

  2. Change in Brief Pain Inventory pain severity subscale

    We will calculate the mean of the four items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate more severe pain. Analyses will examine group differences in change in pain severity.

    Measured: Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)

  3. Change in Brief Pain Inventory pain interference subscale

    We will calculate the mean of the seven items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate greater interference. Analyses will examine group differences in change in pain interference.

    Measured: Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)

  4. Change in Brief Pain Inventory pain interference subscale

    We will calculate the mean of the seven items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate greater interference. Analyses will examine group differences in change in pain interference.

    Measured: Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)

  5. Change in Hospital Anxiety and Depression Scale

    We will reverse score items as necessary, and then sum responses to the measure's 14 items to yield a total score ranging from 0 to 42; higher scores indicate greater emotional distress. Analyses will examine group differences in change in emotional distress.

    Measured: Change in HADS score from baseline to 10-14 weeks post-baseline (Follow up 1)

  6. Change in Hospital Anxiety and Depression Scale

    We will reverse score items as necessary, and then sum responses to the measure's 14 items to yield a total score ranging from 0 to 42; higher scores indicate greater emotional distress. Analyses will examine group differences in change in emotional distress.

    Measured: Change in HADS score from baseline to 22-26 weeks post-baseline (Follow up 2)

  7. Change in Hospital Anxiety and Depression Scale

    We will reverse score items as necessary, and then sum responses to the measure's 14 items to yield a total score ranging from 0 to 42; higher scores indicate greater emotional distress. Analyses will examine group differences in change in emotional distress.

    Measured: Change in HADS score from baseline to 34-38 weeks post-baseline (Follow up 3)

  8. Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)

    We will use the total score for the FACT-B, normalizing scores according to standard scoring methods to yield a score from 0-100; higher scores indicate greater Health-Related Quality of Life (HRQoL). Analyses will examine group differences in change in HRQoL.

    Measured: Change in FACT-B total score from baseline to 10-14 weeks post-baseline (Follow up 1)

  9. Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)

    We will use the total score for the FACT-B, normalizing scores according to standard scoring methods to yield a score from 0-100; higher scores indicate greater Health-Related Quality of Life (HRQoL). Analyses will examine group differences in change in HRQoL.

    Measured: Change in FACT-B total score from baseline to 22-26 weeks post-baseline (Follow up 2)

  10. Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)

    We will use the total score for the FACT-B, normalizing scores according to standard scoring methods to yield a score from 0-100; higher scores indicate greater Health-Related Quality of Life (HRQoL). Analyses will examine group differences in change in HRQoL.

    Measured: Change in FACT-B total score from baseline to 34-38 weeks post-baseline (Follow up 3)

  11. Change in Medication Adherence Rating Scale

    Using standard scoring instructions, we will first rescore each of the 10 items on this scale to indicate adherence (=1) or non-adherence (=0), then sum them to yield a score from 0 to 10; higher scores indicate better self-reported medication adherence. Analyses will examine group differences in change in adherence.

    Measured: Change in MARS scores from baseline to 10-14 weeks post-baseline (Follow up 1)

  12. Change in Medication Adherence Rating Scale

    Using standard scoring instructions, we will first rescore each of the 10 items on this scale to indicate adherence (=1) or non-adherence (=0), then sum them to yield a score from 0 to 10; higher scores indicate better self-reported medication adherence. Analyses will examine group differences in change in adherence.

    Measured: Change in MARS scores from baseline to 22-26 weeks post-baseline (Follow up 2)

  13. Change in Medication Adherence Rating Scale

    Using standard scoring instructions, we will first rescore each of the 10 items on this scale to indicate adherence (=1) or non-adherence (=0), then sum them to yield a score from 0 to 10; higher scores indicate better self-reported medication adherence. Analyses will examine group differences in change in adherence.

    Measured: Change in MARS scores from baseline to 34-38 weeks post-baseline (Follow up 3)

  14. Change in Use event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)

    We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in change in adherence from baseline to each of the post-intervention assessments.

    Measured: Change in MEMS-recorded adherence from baseline to 10-14 weeks post-baseline (Follow up 1)

  15. Probability of optimal adherence using event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)

    We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in probability of optimal adherence, using a dichotomous variable using a cutoff of <80% to identify sub-optimal adherence (where 80% or greater adherence is optimal).

    Measured: Probability of MEMS-recorded optimal adherence from baseline to 10-14 weeks post-baseline (Follow up 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start19 Jan 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
452 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05703178
Sponsor's protocol ID
STU00216520
Other IDs
R01CA271220
Status last verified
Oct 2026
First submitted
11 Jan 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be shared according to the most recent NIH guidelines for sharing research data (https://grants.nih.gov/grants/policy/data\_sharing/). Findings will be disseminated through presentations at national scientific meetings and peer-reviewed manuscripts. We will make our data available for review and/or research to qualified individuals after the main findings from the final dataset are accepted for publication. Individuals requesting data will be asked to describe their goals, data needs and planned analyses including statistical power. Requests will be reviewed by a Data Access Committee made up of the project's key personnel. This committee will evaluate scientific validity, statistical power, overlap with other analyses/publications, and ethical aspects of the proposed use of the data. We will protect the rights and privacy of our study participants by de-identifying the data and taking any other steps necessary to eliminate potential deductive disclosure.

Publications

  • 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. Web-Based Pain Coping Skills Training (PCST) for Managing Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors: Randomized Controlled Trial Protocol. Contemp Clin Trials. 2025 Feb;149:107780. doi: 10.1016/j.cct.2024.107780. Epub 2024 Dec 18.

    PubMed 39706331

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Online Pain Coping Skills Training and Education in people with Breast Cancer and Arthralgia, run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brief Pain Inventory pain severity subscale (time frame: Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703178, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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