To hear about similar clinical trials, please enter your email below
Trial Title:
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
NCT ID:
NCT06534957
Condition:
Breast Cancer
Stress
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
mindfulness-based stress reduction
chemotherapy-related stress
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Intervention:
Intervention type:
Other
Intervention name:
Online mindfulness-based stress reduction
Description:
The online MBSR intervention 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), gentle yoga exercises, and meditation.
Arm group label:
Intervention group
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
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Zambrano Hellion
Address:
City:
San Pedro Garza Garcia
Zip:
66278
Country:
Mexico
Start date:
October 2024
Completion date:
October 2025
Lead sponsor:
Agency:
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Agency class:
Other
Source:
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06534957
