Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Hospital Zambrano Hellion
RECRUITING
San Pedro Garza García
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2026-04
Participants
Target number of participants: 200
Treatments
Experimental: Intervention group
The intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBSR intervention for the next 6 weeks, and will be subsequently reassessed with the study surveys at 7 weeks (T2) and at 11 weeks (T3) of follow-up.
No_intervention: Wait-list control group
A wait-list control group will be used with the objective that all participants have the opportunity of receiving the online MBSR intervention and at the same time allow comparison of the effectiveness of the program with a group without intervention. Given that treatment-related stress has an important negative impact on patients' wellbeing, it is appropriate to offer the control group the possibility of receiving the intervention if its effectiveness is demonstrated.~The control group will be assessed with the study surveys at baseline (T1), will not participate in the online MBSR intervention for the next 6 weeks, and will be subsequently reassessed with the study surveys at the same timepoints as the intervention group at 7 weeks (T2) and at 11 weeks (T3) of follow-up. Upon completion of recruitment and follow-up of all participants, the study will end, and the control group will be able to receive the online MBSR intervention according to their preference.
Related Therapeutic Areas
Sponsors
Leads: Medicos e Investigadores en la Lucha contra el Cancer de Mama

This content was sourced from clinicaltrials.gov