Randomized Study to Evaluate an Intervention Based on Mindfulness to Reduce Anxiety in Breast Cancer Survivors

NCT05837169 | Completed

• 1 other identifier: ECA-MIND
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The diagnosis and treatment of breast cancer (BC) can drastically affect the quality of life of patients with this disease by causing symptoms of vasomotor disorders, insomnia, depression and anxiety. Mindfulness-Based Stress Reduction (MBSR) is a program dedicated to fostering complete awareness in the present in order to accept the moment, thereby reducing stress. Previous studies have shown that MBSR benefits patients with chronic conditions such as mood disorders and chronic pain, as well as patients with BC. However, its usefulness in Mexican patients has not been previously studied.

Conditions

Anxiety; Breast Cancer; Survivorship

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Anxiety level, as measured by the General Anxiety Disorder-7 (GAD-7) tool. GAD-7 is a validated tool made up of 7 items that are each rated from 0-3, thus the total score can range from 0-21. A score between 10-14 suggests moderate anxiety and a score of 15-21 suggests severe anxiety. Therefore, a score ≥10 has been established as cut-off point to identify cases of anxiety.

  8 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The MBSR program will be offered through the Zoom platform. It consists of a total of 8 weekly sessions, with an approximate duration of 2 hours per session. During these sessions, patients will be instructed in exercises to promote mindfulness, including body awareness (body scan), gentle yoga exercises, and meditation. Additionally, a digital manual will be delivered with exercises that can be done at home, 8 audios with guided exercises and a video with balance and flexibility postures. Patients will be instructed to practice mindfulness exercises at least twice a day, lasting approximately 20 min per exercise, to cultivate the incorporation of meditation into their daily lives.

Other: Mindfulness-based stress reduction

Wait-list control group

NO INTERVENTION

Interventions

Mindfulness-based stress reduction OTHER

The control group will be assessed with the study surveys at baseline, will not receive MBSR intervention for the following 8 weeks, and will subsequently be reassessed with the study surveys at the same time points as the intervention group. At the end of the recruitment and follow-up of all the participants, the study will end and the control group will be able to receive the MBSR intervention free of charge according to the preference of the participants.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stage 0-III BC
• Between 1 and 5 years after receiving the diagnosis of BC
• Not being treated with chemotherapy or radiotherapy during the duration of the study
• Score ≥10 on the GAD-7 tool (moderate to severe anxiety)
• Internet access at home
• Availability to participate in the MBSR intervention virtually for 8 weeks
• Availability to answer the follow-up questionnaires during the duration of the study

You may not qualify if:

• Metastatic disease
• Score \<10 on the GAD-7 tool (mild anxiety)
• Current meditation practice
• Inability to read or write

Sponsors & Collaborators

• Medicos e Investigadores en la Lucha contra el Cancer de Mama: lead

Study Sites (1)

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Related Publications (1)

• Ferrigno Guajardo A, Salazar-Alejo M, Mesa-Chavez F, Gutierrez-Ornelas J, Platas A, Verduzco-Aguirre H, Villarreal-Garza C. Effectiveness of an online mindfulness-based stress-reduction intervention to reduce anxiety in breast cancer survivors: a randomized-controlled trial. Support Care Cancer. 2025 Jun 24;33(7):623. doi: 10.1007/s00520-025-09681-6.

  PMID: 40555874 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention, the study will be open and participants will know which group they belong to. However, the statistician will be blinded in order to reduce the risk of introducing bias when interpreting the data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: September 23, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)