Back to resultsWeb-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
Primary Purpose
Breast Cancer, Arthralgia, Pain, Chronic
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Online Pain Coping Skills Training
Education
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments
Eligibility Criteria
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) Postmenopausal due to ovarian suppression rather than natural menopause 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)
Sites / Locations
- Northwestern UniversityRecruiting
- Duke UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Education + Online Pain Coping Skill Training
Education
Arm Description
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. 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.
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.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
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).
Full Information
NCT ID
NCT05703178
First Posted
January 11, 2023
Last Updated
March 28, 2023
Sponsor
Northwestern University
Collaborators
Duke University, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05703178
Brief Title
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Duke University, National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives.
Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications.
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.
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:
Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months.
Attend 3 meetings in the first month of the study, all of which can be held via a video conference.
Use an electronic pill bottle to track their use of their AI medication.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Arthralgia, Pain, Chronic
Keywords
Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
452 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education + Online Pain Coping Skill Training
Arm Type
Experimental
Arm Description
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. 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.
Arm Title
Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Pain Coping Skills Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory pain severity subscale
Description
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.
Time Frame
Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Brief Pain Inventory pain interference subscale
Description
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.
Time Frame
Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)
Secondary Outcome Measure Information:
Title
Change in Brief Pain Inventory pain severity subscale
Description
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.
Time Frame
Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Brief Pain Inventory pain severity subscale
Description
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.
Time Frame
Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Brief Pain Inventory pain interference subscale
Description
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.
Time Frame
Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Brief Pain Inventory pain interference subscale
Description
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.
Time Frame
Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Change in HADS score from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Change in HADS score from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Change in HADS score from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)
Description
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.
Time Frame
Change in FACT-B total score from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)
Description
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.
Time Frame
Change in FACT-B total score from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)
Description
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.
Time Frame
Change in FACT-B total score from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Medication Adherence Rating Scale
Description
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.
Time Frame
Change in MARS scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Medication Adherence Rating Scale
Description
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.
Time Frame
Change in MARS scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Medication Adherence Rating Scale
Description
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.
Time Frame
Change in MARS scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Use event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)
Description
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.
Time Frame
Change in MEMS-recorded adherence from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Use event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)
Description
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.
Time Frame
Change in MEMS-recorded adherence from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Use event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)
Description
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.
Time Frame
Change in MEMS-recorded adherence from baseline to 34-38 weeks post-baseline (Follow up 3
Title
Probability of optimal adherence using event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)
Description
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).
Time Frame
Probability of MEMS-recorded optimal adherence from baseline to 34-38 weeks post-baseline (Follow up 3)
Other Pre-specified Outcome Measures:
Title
Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale
Description
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.
Time Frame
Change in Self-efficacy for pain management from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale
Description
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.
Time Frame
Change in Self-efficacy for pain management from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale
Description
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.
Time Frame
Change in Self-efficacy for pain management from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Pain Catastrophizing Scale
Description
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.
Time Frame
Change in PCS scale scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Pain Catastrophizing Scale
Description
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.
Time Frame
Change in PCS scale scores from baseline to 22-24 weeks post-baseline (Follow up 2)
Title
Change in Pain Catastrophizing Scale
Description
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.
Time Frame
Change in PCS scale scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance
Description
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.
Time Frame
Change in PROMIS sleep disturbance scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance
Description
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.
Time Frame
Change in PROMIS sleep disturbance scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance
Description
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.
Time Frame
Change in PROMIS sleep disturbance scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in PROMIS 8-item Sleep-Related Impairment
Description
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.
Time Frame
Change in PROMIS sleep-related impairment scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in PROMIS 8-item Sleep-Related Impairment
Description
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.
Time Frame
Change in PROMIS sleep-related impairment scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in PROMIS 8-item Sleep-Related Impairment
Description
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.
Time Frame
Change in PROMIS sleep-related impairment scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Title
Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale
Description
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.
Time Frame
Change in MENQOL scores from baseline to 10-14 weeks post-baseline (Follow up 1)
Title
Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale
Description
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.
Time Frame
Change in MENQOL scores from baseline to 22-26 weeks post-baseline (Follow up 2)
Title
Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale
Description
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.
Time Frame
Change in MENQOL scores from baseline to 34-38 weeks post-baseline (Follow up 3)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Postmenopausal due to ovarian suppression rather than natural menopause
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Rini, PhD
Phone
312-503-7715
Email
christine.rini@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rahma Omar
Phone
312-503-1725
Email
Rahma.Omar@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Rini, PhD
Phone
312-503-7715
Email
christine.rini@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Rahma Omar
Phone
312-503-1725
Email
Rahma.Omar@northwestern.edu
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Somers
Phone
919-416-3408
Email
tamara.somers@duke.edu
First Name & Middle Initial & Last Name & Degree
Shannon Miller
Email
shannon.n.miller@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
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Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
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