Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Stress

• Registration Number: NCT06534957
• Lead Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Study Start: 2025-04
• Primary Completion: 2026-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 20-25 points, and a high stress level is considered when obtaining \>25 points.

Trial Locations

Locations (1)

Hospital Zambrano Hellion; 🇲🇽 San Pedro Garza Garcia, Nuevo Leon, Mexico