Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529120
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women with breast cancer often experience multiple difficult symptoms for example insomnia fatigue stress and pain This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer Nite2Day Participants will complete six 45-60 minute intervention sessions with a study therapist Intervention sessions will be conducted remotely via conference ie Zoom or telephone During these sessions participants will learn mindfulness and cognitive-behavioral strategies to cope with nighttime sleep disturbances and daytime symptoms of fatigue stress and pain Participants will be asked to complete three brief 15-20 minute surveys that will ask questions about their background cancer diagnosis and treatments cancer symptoms and experience with the intervention Participants will be compensated for completing all intervention sessions and surveys Total study duration is about 12 weeks
The greatest risk of this study is loss of confidentiality Benefits from participating might include learning skills to reduce nighttime sleep disturbances and daytime symptoms of fatigue stress and pain Information learned from this study may also benefit other patients with cancer in the future
The greatest risk of this study is loss of confidentiality Benefits from participating might include learning skills to reduce nighttime sleep disturbances and daytime symptoms of fatigue stress and pain Information learned from this study may also benefit other patients with cancer in the future
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None