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| Name | Class |
|---|---|
| Duke University | OTHER |
| National Cancer Institute (NCI) | NIH |
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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:
Participants can complete all parts of the study at home. They will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education + Online Pain Coping Skill Training | Experimental | 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. |
|
| Education | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Pain Coping Skills Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39706331 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018771 | Arthralgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
| Education | Other | 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. |
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 10-14 weeks post-baseline (Follow up 3) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Durham |
| North Carolina |
| 27708 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |