Health TrialsbyHealthPanel

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

ConditionsBreast CancerArthralgiaPain, Chronic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorthwestern University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Female sex

Aged 18 years old or older

Diagnosed with Stage 0-III hormone receptor positive breast cancer

Completed primary cancer treatment (surgery, chemotherapy, and/or radiation therapy)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Education

    Other intervention

    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.

Treatment groups

452 Participants
are divided into 2 treatment groups
Group A: Education + Online Pain Coping Skill TrainingExperimental treatment 2 interventions
Group B: EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)
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.

Time frame
Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)

Secondary outcomes

1

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.

Time frame
Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
2

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.

Time frame
Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)
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.

Time frame
Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)
4

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.

Time frame
Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)

Other outcomes

1

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.

Time frame
Change in Self-efficacy for pain management from baseline to 10-14 weeks post-baseline (Follow up 1)
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.

Time frame
Change in Self-efficacy for pain management from baseline to 22-26 weeks post-baseline (Follow up 2)
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.

Time frame
Change in Self-efficacy for pain management from baseline to 34-38 weeks post-baseline (Follow up 3)
4

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.

Time frame
Change in PCS scale scores from baseline to 10-14 weeks post-baseline (Follow up 1)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Duke University

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now