Mindfulness-Based Stress Reduction in Helping Participants With Metastatic Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | December 13, 2017 |
| End Date: | December 5, 2019 |
RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients
This randomized trial studies how well a mindfulness-based stress reduction program helps
participants with breast cancer that has spread to other places in the body. A cancer
diagnosis is a life-changing and highly stressful event for most people, often resulting in
marked declines in quality of life both during and after treatment. There are approximately 3
million women living with a history of invasive breast cancer in the U.S., with at least
150,000 living with metastatic disease. Patient preferences suggest a high need for
complementary and alternative medicine interventions to address these chronic symptoms.
Mindfulness-based stress reduction programs may help women living with metastatic breast
cancer manage symptoms related to cancer treatment and improve quality of life.
participants with breast cancer that has spread to other places in the body. A cancer
diagnosis is a life-changing and highly stressful event for most people, often resulting in
marked declines in quality of life both during and after treatment. There are approximately 3
million women living with a history of invasive breast cancer in the U.S., with at least
150,000 living with metastatic disease. Patient preferences suggest a high need for
complementary and alternative medicine interventions to address these chronic symptoms.
Mindfulness-based stress reduction programs may help women living with metastatic breast
cancer manage symptoms related to cancer treatment and improve quality of life.
PRIMARY OBJECTIVES:
I. To develop a novel online mindfulness-based stress reduction (MBSR) treatment for
distressed metastatic breast cancer patients in the hope of reaching patients otherwise
unable to participate in traditional interventions due to high symptom burden.
II. Determine the impact of the intervention on both patient self-report and biological
symptom measures.
OUTLINE: Participants are randomized to 1 of 2 arms.
INTERVENTION ARM: Participants receive online group sessions over 60 minutes for 6 weeks,
including 15 minutes of practice on that session's topic and daily meditation or yoga for 45
minutes. At the conclusion of the study period participants participate in mindfulness
meditation over 3 hours. Participants also receive a content manual and relaxation compact
disc (CD).
CONTROL ARM: Participants randomized to the wait-list control condition complete the online
intervention as in the intervention arm after the initial 6-week period has ended.
I. To develop a novel online mindfulness-based stress reduction (MBSR) treatment for
distressed metastatic breast cancer patients in the hope of reaching patients otherwise
unable to participate in traditional interventions due to high symptom burden.
II. Determine the impact of the intervention on both patient self-report and biological
symptom measures.
OUTLINE: Participants are randomized to 1 of 2 arms.
INTERVENTION ARM: Participants receive online group sessions over 60 minutes for 6 weeks,
including 15 minutes of practice on that session's topic and daily meditation or yoga for 45
minutes. At the conclusion of the study period participants participate in mindfulness
meditation over 3 hours. Participants also receive a content manual and relaxation compact
disc (CD).
CONTROL ARM: Participants randomized to the wait-list control condition complete the online
intervention as in the intervention arm after the initial 6-week period has ended.
Inclusion Criteria:
- A diagnosis of metastatic breast cancer within the past 5 years and treated at Roswell
Park Cancer Institute (RPCI)
- Ability to read and understand English
- Current distress score of 4+ on the National Comprehensive Cancer Network (NCCN)
distress thermometer
- Access to an Internet connection with own device (computer, tablet, smartphone, etc.)
- Patient not currently involved in an ongoing psychological intervention
- If taking prescribed medication for mood or anxiety disorder, dosage has been
consistent for prior 3 months
Exclusion Criteria:
- Unable to speak and understand English
- Prior or current experience with mindfulness-based practice
- Diagnosis of a psychotic disorder, bipolar disorder, substance abuse disorder, or
reported suicidality
- Current involvement in any other psychological treatment (excluding medication) during
study duration
- Currently being treated for another cancer diagnosis other than metastatic breast
cancer
We found this trial at
1
site
666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Jennifer Hydeman
Phone: 716-845-4187
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
Click here to add this to my saved trials
