Supporting Women With Breast Cancer to Prepare for Treatment (The Prepare Study)

Endeavor Health

Status: Completed

Conditions: Breast Cancer; Mindfulness

Treatments: Behavioral: Mindfulness Arm; Other: Control group placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07221071

EH20-134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups, including a placebo group

Mindfulness Arm

Experimental group

Description:

Brief video and audio practice of mindfulness

Treatment:

Behavioral: Mindfulness Arm

Health Videos - Mike Evans

Placebo Comparator group

Description:

Brief videos focusing on health and wellness

Treatment:

Other: Control group placebo