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NCT06534957 | NOT YET RECRUITING | Breast Cancer

Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
Sponsor:

Doctors and Researchers in the Fight against Breast Cancer

Information provided by (Responsible Party):

Fernanda Mesa-Chavez

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

Condition or disease

Breast Cancer

Stress

Intervention/treatment

Online mindfulness-based stress reduction

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : SINGLE
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.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy
Actual Study Start Date : 2024-10
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

Location Details

NCT06534957

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Mexico, New Leon

Hospital Zambrano Hellion

San Pedro Garza Garcia, New Leon, Mexico, 66278