Breast Cancer, Stress
Conditions
Keywords
breast cancer, mindfulness-based intervention, mindfulness, online mindfulness, chemotherapy-related stress, treatment-related stress
Brief summary
The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based intervention (MBI) reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy. The main questions it aims to answer are: * Does an online MBI intervention reduce stress levels (measured through the Perceived Stress Scale) among participants? * Does an online MBI 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 MBI to no intervention to see if online MBI reduces treatment-related stress. Participants will: * Participate in an online MBI or no intervention for 6 weeks * Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up
Interventions
OTHEROnline mindfulness-based stress reduction
The online MBI sessions will be available in a website created specifically for this purpose, where each pre-recorded session will be uploaded so that each patient can begin the intervention at the same time as their chemotherapy regimen. Each session will last approximately 1 hour, for a total of 6 sessions. The topics that will be covered in these sessions include: mindfulness overview, stress and suffering, emotional regulation, meditation, management of stressful situations, self-compassion and acceptance. Participants will watch 1 session per week following the order that will be indicated on the website; patients will be encouraged to watch the sessions during their chemotherapy infusions. During these sessions, patients will be instructed in mindfulness practice and will perform targeted exercises to promote complete consciousness, including mindful body awareness (body scan) and meditation.
Sponsors
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Given the nature of the intervention, the study will be open and participants will know which group they were randomized to. However, the study will be blinded to the statistician in order to reduce the risk of introducing bias when interpreting the data.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female sex * Age ≥18 years * Diagnosis of non-metastatic breast cancer * Treatment with neoadjuvant or adjuvant chemotherapy or plan to start chemotherapy in \<4 weeks * Internet access at home or in their mobile phone * Availability to participate in the online MBI 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress | 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 14-26 points, and a high stress level is considered when obtaining \>27 points. |
Countries
Mexico
Outcome results
None listed