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Trial Title:
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
NCT ID:
NCT05703178
Condition:
Breast Cancer
Arthralgia
Pain, Chronic
Conditions: Official terms:
Breast Neoplasms
Arthralgia
Chronic Pain
Conditions: Keywords:
Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Online Pain Coping Skills Training
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.
Arm group label:
Education + Online Pain Coping Skill Training
Intervention type:
Other
Intervention name:
Education
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.
Arm group label:
Education
Arm group label:
Education + Online Pain Coping Skill Training
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.
Criteria for 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Rini, PhD
Phone:
312-503-7715
Email:
christine.rini@northwestern.edu
Contact backup:
Last name:
Zahra Hosseinian
Email:
zahra.hosseinian@northwestern.edu
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27708
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tamara Somers
Phone:
919-416-3408
Email:
tamara.somers@duke.edu
Contact backup:
Last name:
Shannon Miller
Email:
shannon.n.miller@duke.edu
Start date:
January 19, 2023
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703178
