Breast Cancer, Mindfulness
Conditions
Keywords
Cancer Surgery, Mindfulness, Breast Cancer
Brief summary
The purpose of this study is to evaluate if a brief mindfulness intervention before and after surgery would impact patient emotional wellbeing, quality of life, and biomarkers measured before and after surgery by finger prick collection and surveys.
Detailed description
The purpose of this project is to evaluate a brief, technology-enabled mindfulness intervention before and following breast cancer surgery to determine its impact on emotional wellbeing and biological stress response in breast cancer patients. The investigators will administer self-reported questionnaires of emotional wellbeing and quality of life and collect pro and anti-inflammatory cytokines (CRP and IL-10, respectively) using a minimally invasive finger prick approach. The findings from this study will help establish an evidence base on the efficacy of a brief, technology enabled mindfulness intervention on patient anxiety, wellbeing and biological response. No previous studies have examined the impact of a brief mindfulness training prior to and following surgery on patient wellbeing. The long-term goal is to determine whether brief, technology-enabled mindfulness support can become part of routine preparation for breast cancer surgery.
Interventions
BEHAVIORALMindfulness Arm
Participants will be instructed to watch four brief breast cancer specific educational mindfulness videos (within the first week of randomization), listen to guided audio recordings of different mindfulness meditations at least 3 times per week throughout the intervention period (which lasts until the Time 3 Assessment), and complete brief, post-listening written reflections in a journal (NOW reflections) that is provided to them during the intervention period.
Participants will receive brief videos that focuses on general health behaviors. We will utilize the Mike Evans chalkboard videos (https://www.reframehealthlab.com/category/whiteboard-health-videos/) as the control for this group. Participants will view the Mike Evans videos within the first week following randomization. The participants will be assigned to watch 10 videos located on the Group B study website. Topics range from cancer fatigue, healthy eating, benefits of exercise, and the science of happiness.
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Females \>20 and \< 85 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Anxiety | 3 months | To measure the impact of a mindfulness intervention instituted prior to surgery on patient anxiety for newly diagnosed breast cancer patients, using the PROMIS anxiety questionnaire \[Emotional Distress - Anxiety - Short Form 8a answer options are: Never, Rarely, Sometimes, Often, Always\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Depression | 3 months | To measure the impact of a mindfulness intervention on patient depression using the \[PROMIS Emotional Distress - Depression - Short Form 8a questionnaire - options are Never, Rarely, Sometimes, Often, Always\]. |
| Psychosocial wellbeing | 3 months | To compare psychosocial wellbeing as it pertains to body image between those receiving a mindfulness intervention or general overall health videos, by using the Breast Q questionnaire - answer options are: None of the time, A little of the time, some of the time, most of the time, and all of the time. |
| Stress biomarker | 3 months | To determine if a mindfulness intervention will impact stress biomarker profiles. Participants will be asked to provide self-collected whole dried blood spots to assess IL-6, CRP, and TNF-α using a minimally invasive finger skin prick technique, which involves pricking the finger with a lancet, milking the finger to produce 5 drops of blood onto filter paper, allowing the blood spots to dry, and mailing it to the study team at MGH in a secure envelope. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-Kindness questionnaire | 3 months | To measure patient self- compassion and kindness. using a (Self-Compassion Scale-5 items- answer choices are: Almost Never, Never, Sometimes, Always, Almost Always) |
| Emotional Reactivity/Regulation and Mindfulness Awareness | 3 months | Patients will complete the Nonreactivity scale (Five Facet Mindfulness Questionnaire-7 items - answer choices are: Never or very rarely true, Rarely true, Sometimes true, Often true, and Very often true or always true). |
| Exploratory | 3 months | To determine if a mindfulness intervention will impact patient fear of recurrence, using a fear of recurrence questionnaire - answer options are strongly disagree, disagree, not certain, agree, strongly agree. |
Countries
United States
Outcome results
None listed