Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01674881
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2012-08-24
Brief Title:
The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy MBCT on Chronic Pain in Women Treated for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
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:
A recent epidemiologic survey has indicated that approx 42 of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment Chronic pain is known to be associated with impaired social and emotional functioning and thus presents a particular concern
Mindfulness-based intervention is among the complementary psychological treatments which cancer patients commonly seek out in relation to the course of their illness Despite the popularity of mindfulness-based intervention among cancer patients no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients While no studies so far have focused on pain there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer Furthermore non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences
The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy MBCT on chronic pain in breast cancer patients Women who have completed their treatment for breast cancer and who experience chronic pain will be randomized to an intervention group MBCT or a treatment-as-usual control group All participants will be assessed at the same time points ie before the intervention baseline and three times after the interventioncontrol condition with the last follow-up 6 months after the intervention In addition a number of potential moderators and mediators of the outcome will be explored For example recent studies indicate that adult attachment style may constitute an important moderator andor mediator in the development of pain and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention
The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients will contribute to the clarification of underlying mechanisms in the experience of and coping with pain which could help the development of more effective individualized interventions
Mindfulness-based intervention is among the complementary psychological treatments which cancer patients commonly seek out in relation to the course of their illness Despite the popularity of mindfulness-based intervention among cancer patients no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients While no studies so far have focused on pain there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer Furthermore non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences
The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy MBCT on chronic pain in breast cancer patients Women who have completed their treatment for breast cancer and who experience chronic pain will be randomized to an intervention group MBCT or a treatment-as-usual control group All participants will be assessed at the same time points ie before the intervention baseline and three times after the interventioncontrol condition with the last follow-up 6 months after the intervention In addition a number of potential moderators and mediators of the outcome will be explored For example recent studies indicate that adult attachment style may constitute an important moderator andor mediator in the development of pain and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention
The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients will contribute to the clarification of underlying mechanisms in the experience of and coping with pain which could help the development of more effective individualized interventions
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