Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05703178
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-01-11
Brief Title:
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 womens 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
1 Whether online pain coping skills training reduces the severity of pain and the interference it causes in womens 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 womens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None