Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy

Medicos e Investigadores en la Lucha contra el Cancer de Mama

Status: Enrolling

Conditions: Breast Cancer; Stress

Treatments: Other: Online mindfulness-based stress reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT06534957

ECA-MIND-QT

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Online mindfulness-based stress reduction

Wait-list control group

No Intervention group

Description:

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.