Clinical trial NCT05703178: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Arthralgia
Pain, Chronic
Keywords: Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Duke University
name: National Cancer Institute (NCI)
First posted: 2023-01-27
Enrollment: 452
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


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)
* 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)

Primary outcomes:
measure: Change in Brief Pain Inventory pain severity subscale
timeFrame: Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Brief Pain Inventory pain interference subscale
timeFrame: Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)
Secondary outcomes:
measure: Change in Brief Pain Inventory pain severity subscale
timeFrame: Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Brief Pain Inventory pain severity subscale
timeFrame: Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Brief Pain Inventory pain interference subscale
timeFrame: Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Brief Pain Inventory pain interference subscale
timeFrame: Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Change in HADS score from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Change in HADS score from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Change in HADS score from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)
timeFrame: Change in FACT-B total score from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)
timeFrame: Change in FACT-B total score from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)
timeFrame: Change in FACT-B total score from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Medication Adherence Rating Scale
timeFrame: Change in MARS scores from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Medication Adherence Rating Scale
timeFrame: Change in MARS scores from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Medication Adherence Rating Scale
timeFrame: Change in MARS scores from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Use event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)
timeFrame: Change in MEMS-recorded adherence from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Probability of optimal adherence using event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)
timeFrame: Probability of MEMS-recorded optimal adherence from baseline to 10-14 weeks post-baseline (Follow up 3)
Other outcomes:
measure: Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale
timeFrame: Change in Self-efficacy for pain management from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale
timeFrame: Change in Self-efficacy for pain management from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale
timeFrame: Change in Self-efficacy for pain management from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Pain Catastrophizing Scale
timeFrame: Change in PCS scale scores from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Pain Catastrophizing Scale
timeFrame: Change in PCS scale scores from baseline to 22-24 weeks post-baseline (Follow up 2)
measure: Change in Pain Catastrophizing Scale
timeFrame: Change in PCS scale scores from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance
timeFrame: Change in PROMIS sleep disturbance scores from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance
timeFrame: Change in PROMIS sleep disturbance scores from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) 8-item Sleep Disturbance
timeFrame: Change in PROMIS sleep disturbance scores from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in PROMIS 8-item Sleep-Related Impairment
timeFrame: Change in PROMIS sleep-related impairment scores from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in PROMIS 8-item Sleep-Related Impairment
timeFrame: Change in PROMIS sleep-related impairment scores from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in PROMIS 8-item Sleep-Related Impairment
timeFrame: Change in PROMIS sleep-related impairment scores from baseline to 34-38 weeks post-baseline (Follow up 3)
measure: Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale
timeFrame: Change in MENQOL scores from baseline to 10-14 weeks post-baseline (Follow up 1)
measure: Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale
timeFrame: Change in MENQOL scores from baseline to 22-26 weeks post-baseline (Follow up 2)
measure: Change in Menopause Specific quality of Life Questionnaire (MENQOL) Vasomotor Subscale
timeFrame: Change in MENQOL scores from baseline to 34-38 weeks post-baseline (Follow up 3)
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: