Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de Mama
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Stress
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based stress reduction (MBSR) intervention reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.
The main questions it aims to answer are:
- Does an online MBSR intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?
- Does an online MBSR intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?
Researchers will compare the online MBSR intervention to no intervention to see if online MBSR reduces treatment-related stress.
Participants will:
- Participate in an online MBSR intervention or no intervention for 6 weeks
- Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up
Investigators
Fernanda Mesa-Chavez
Principal Investigator
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Eligibility Criteria
Inclusion Criteria
- •Female sex
- •Age ≥18 years
- •Diagnosis of non-metastatic breast cancer
- •Plan to start neoadjuvant or adjuvant chemotherapy in \<4 weeks
- •Internet access at home or in their mobile phone
- •Availability to participate in the online MBSR intervention for 6 weeks
- •Availability to answer the study surveys
- •Provision of signed informed consent
Exclusion Criteria
- •Disease recurrence
- •Current meditation or mindfulness practice
- •Inability to read or write
Outcomes
Primary Outcomes
Stress
Time Frame: 11 weeks
Measured through the Perceived Stress Scale (PSS). The PSS is a self-report instrument that assesses the level of perceived stress over the past month. It consists of 10 items that are rated using a 5-point Likert scale (0: Never; 1: Almost never; 2: Sometimes; 3: Fairly often; 4: Very often). The total score is obtained by adding the scores of the 10 items, obtaining a total value between 0-40, where higher scores indicate a higher level of perceived stress. A moderate stress level is considered between 20-25 points, and a high stress level is considered when obtaining \>25 points.