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

Status: Completed

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 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

Eligibility

Participation Requirements

Sex: Female

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

Mexico

Hospital Zambrano Hellion

San Pedro Garza García

Time Frame

Start Date: 2025-09-02

Completion Date: 2026-06-01

Participants

Target number of participants: 128

Treatments

Experimental: Intervention group

The intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBI 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 MBI 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 MBI 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 MBI according to their preference.

Related Therapeutic Areas

Breast Cancer

Diarrhea

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