Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 20 - 70 |
| Updated: | 3/21/2019 |
| Start Date: | November 8, 2018 |
| End Date: | November 8, 2020 |
The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
In this study the investigators propose to pilot test a brief, mindfulness shared decision
making intervention that begins shortly after receiving a diagnosis of breast cancer. A
mindfulness instructor will conduct an hour long session with consented participants before
the scheduled surgical appointment. The investigators hypothesize that a mindfulness
intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately
lead to increased decisional satisfaction and alignment to participant's values and
preferences, and decreased anxiety. To measure this endpoint, participants will complete
three surveys via REDCap- at baseline, before surgery, and 6 months postoperatively. Surveys
will include questions on quality of life, anxiety, and participant satisfaction with the
mindfulness program.
making intervention that begins shortly after receiving a diagnosis of breast cancer. A
mindfulness instructor will conduct an hour long session with consented participants before
the scheduled surgical appointment. The investigators hypothesize that a mindfulness
intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately
lead to increased decisional satisfaction and alignment to participant's values and
preferences, and decreased anxiety. To measure this endpoint, participants will complete
three surveys via REDCap- at baseline, before surgery, and 6 months postoperatively. Surveys
will include questions on quality of life, anxiety, and participant satisfaction with the
mindfulness program.
The primary aim of this study is to identify if a mindfulness intervention is feasible before
the participant has their surgical consultation. The secondary aim is to measure the impact
of the mindfulness intervention on participant reported outcomes including anxiety, quality
of life and decisional satisfaction. Newly diagnosed female breast cancer patients will be
contacted over the phone after the patient learns of their diagnosis but prior to their
surgical appointment to discuss surgical options. Verbal consent will be obtained over the
phone and the participant will be directed to complete an online survey to answer baseline
questions on their anxiety and quality of life as well as to provide their contact
information and availability in order to schedule a mindfulness session with a certified
mindfulness teacher. The participant will then proceed to an hour-long mindfulness exercise
geared to help women apply these techniques to the decisional making process. The goal is to
empower women to approach their diagnosis and treatment decisions with greater stability and
improve their ability to focus on their values and preferences instead of just focusing on
the diagnosis. This will be measured by administering patient reported outcomes (PROs) via
REDCap online surveys at three timepoints. The first PRO "baseline survey" is administered
after the participant enrolls but before the mindfulness session. The second PRO "before
surgery survey" is completed after the surgical consultation but prior to the scheduled
surgery. The final PRO "6-month survey" is administered 6 months after the surgery to measure
quality of life, anxiety, and participant satisfaction with the mindfulness program. The
investigators hypothesize that a mindfulness intervention delivered shortly after receiving a
diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and
alignment to participant's values and preferences, and decreased anxiety.
the participant has their surgical consultation. The secondary aim is to measure the impact
of the mindfulness intervention on participant reported outcomes including anxiety, quality
of life and decisional satisfaction. Newly diagnosed female breast cancer patients will be
contacted over the phone after the patient learns of their diagnosis but prior to their
surgical appointment to discuss surgical options. Verbal consent will be obtained over the
phone and the participant will be directed to complete an online survey to answer baseline
questions on their anxiety and quality of life as well as to provide their contact
information and availability in order to schedule a mindfulness session with a certified
mindfulness teacher. The participant will then proceed to an hour-long mindfulness exercise
geared to help women apply these techniques to the decisional making process. The goal is to
empower women to approach their diagnosis and treatment decisions with greater stability and
improve their ability to focus on their values and preferences instead of just focusing on
the diagnosis. This will be measured by administering patient reported outcomes (PROs) via
REDCap online surveys at three timepoints. The first PRO "baseline survey" is administered
after the participant enrolls but before the mindfulness session. The second PRO "before
surgery survey" is completed after the surgical consultation but prior to the scheduled
surgery. The final PRO "6-month survey" is administered 6 months after the surgery to measure
quality of life, anxiety, and participant satisfaction with the mindfulness program. The
investigators hypothesize that a mindfulness intervention delivered shortly after receiving a
diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and
alignment to participant's values and preferences, and decreased anxiety.
Inclusion Criteria:
1. Females >20 and < 70 years of age
2. History of contralateral breast cancer in the past is acceptable
3. Patients seeking second opinion for diagnosis are eligible
4. Clinical AJCC stage 0-III breast cancer
5. Patients who have an in breast tumor recurrence are eligible
6. English Speaking
7. Willing to fill out surveys required for the study
8. Gene mutation carriers are eligible
9. Neoadjuvant therapy patients are eligible
Exclusion Criteria:
1. AJCC Stage IV breast cancer
2. Unwilling to fill out surveys for the study
3. Patients with a distant recurrence
4. Patients unaware of their diagnosis
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