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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703178
• Other study ID #: STU00216520
• Status: Recruiting
• Phase: Phase 3
• Start date: January 19, 2023
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Christine Rini, PhD
• Phone: 312-503-7715
• Email: christine.rini[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms
• Chronic Pain
• Pain, Chronic

Intervention

Behavioral:
• Online Pain Coping Skills Training
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.

Other:
• Education
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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Duke University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale	Using standard scoring procedures, we will calculate the mean of responses to this subscale's 5 items to yield a total score ranging from 10-100, where higher scores indicate greater self-efficacy for managing chronic pain. Analyses will examine change in pain self-efficacy.	Change in Self-efficacy for pain management from baseline to 10-14 weeks post-baseline (Follow up 1)
Other	Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale	Using standard scoring procedures, we will calculate the mean of responses to this subscale's 5 items to yield a total score ranging from 10-100, where higher scores indicate greater self-efficacy for managing chronic pain. Analyses will examine change in pain self-efficacy.	Change in Self-efficacy for pain management from baseline to 22-26 weeks post-baseline (Follow up 2)
Other	Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale	Using standard scoring procedures, we will calculate the mean of responses to this subscale's 5 items to yield a total score ranging from 10-100, where higher scores indicate greater self-efficacy for managing chronic pain. Analyses will examine change in pain self-efficacy.	Change in Self-efficacy for pain management from baseline to 34-38 weeks post-baseline (Follow up 3)
Other	Change in Pain Catastrophizing Scale	Using standard scoring methods, we will sum responses for the 13 items on this scale to yield a score ranging from 0-52, where higher scores indicate greater pain catastrophizing. Analyses will examine change in pain catastrophizing from baseline; change from baseline to post-intervention (follow up 1) will also be examined as a potential mediator of changes in pain severity and interference.	Change in PCS scale scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Other	Change in Pain Catastrophizing Scale	Using standard scoring methods, we will sum responses for the 13 items on this scale to yield a score ranging from 0-52, where higher scores indicate greater pain catastrophizing. Analyses will examine change in pain catastrophizing.	Change in PCS scale scores from baseline to 22-24 weeks post-baseline (Follow up 2)
Other	Change in Pain Catastrophizing Scale	Using standard scoring methods, we will sum responses for the 13 items on this scale to yield a score ranging from 0-52, where higher scores indicate greater pain catastrophizing. Analyses will examine change in pain catastrophizing.	Change in PCS scale scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Other	Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance	Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep disturbance. Analyses will examine group differences in change in sleep disturbance.	Change in PROMIS sleep disturbance scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Other	Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance	Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep disturbance. Analyses will examine group differences in change in sleep disturbance.	Change in PROMIS sleep disturbance scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Other	Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance	Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep disturbance. Analyses will examine group differences in change in sleep disturbance.	Change in PROMIS sleep disturbance scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Other	Change in PROMIS 8-item Sleep-Related Impairment	Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep-related impairment. Analyses will examine group differences in change in sleep-related impairment.	Change in PROMIS sleep-related impairment scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Other	Change in PROMIS 8-item Sleep-Related Impairment	Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep-related impairment. Analyses will examine group differences in change in sleep-related impairment.	Change in PROMIS sleep-related impairment scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Other	Change in PROMIS 8-item Sleep-Related Impairment	Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep-related impairment. Analyses will examine group differences in change in sleep-related impairment.	Change in PROMIS sleep-related impairment scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Other	Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale	Using standard scoring procedures for the 3-item vasomotor subscale, we will calculate the mean of responses to yield a score ranging from 1 to 8; higher scores indicated higher vasomotor symptoms. Analyses will examine change in vasomotor symptoms.	Change in MENQOL scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Other	Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale	Using standard scoring procedures for the 3-item vasomotor subscale, we will calculate the mean of responses to yield a score ranging from 1 to 8; higher scores indicated higher vasomotor symptoms. Analyses will examine change in vasomotor symptoms.	Change in MENQOL scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Other	Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale	Using standard scoring procedures for the 3-item vasomotor subscale, we will calculate the mean of responses to yield a score ranging from 1 to 8; higher scores indicated higher vasomotor symptoms. Analyses will examine change in vasomotor symptoms.	Change in MENQOL scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Primary	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.	Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)
Primary	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.	Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)
Secondary	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.	Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
Secondary	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.	Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)
Secondary	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.	Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
Secondary	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.	Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)
Secondary	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.	Change in HADS score from baseline to 10-14 weeks post-baseline (Follow up 1)
Secondary	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.	Change in HADS score from baseline to 22-26 weeks post-baseline (Follow up 2)
Secondary	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.	Change in HADS score from baseline to 34-38 weeks post-baseline (Follow up 3)
Secondary	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.	Change in FACT-B total score from baseline to 10-14 weeks post-baseline (Follow up 1)
Secondary	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.	Change in FACT-B total score from baseline to 22-26 weeks post-baseline (Follow up 2)
Secondary	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.	Change in FACT-B total score from baseline to 34-38 weeks post-baseline (Follow up 3)
Secondary	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.	Change in MARS scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Secondary	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.	Change in MARS scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Secondary	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.	Change in MARS scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Secondary	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.	Change in MEMS-recorded adherence from baseline to 10-14 weeks post-baseline (Follow up 1)
Secondary	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.	Change in MEMS-recorded adherence from baseline to 22-26 weeks post-baseline (Follow up 2)
Secondary	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.	Change in MEMS-recorded adherence from baseline to 34-38 weeks post-baseline (Follow up 3
Secondary	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).	Probability of MEMS-recorded optimal adherence from baseline to 34-38 weeks post-baseline (Follow up 3)