Online mindfulness program to reduce chemotherapy-related stress
Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy
This study will test whether a 6-week online mindfulness-based stress reduction program can reduce stress in women with non-metastatic breast cancer starting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medicos e Investigadores en la Lucha contra el Cancer de Mama Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (San Pedro Garza García, Nuevo León) |
| Trial ID | NCT06534957 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, waitlist-controlled trial comparing a 6-week online MBSR program to no intervention in women beginning neoadjuvant or adjuvant chemotherapy. Participants are randomized 1:1 and complete surveys at baseline, 7 weeks, and 11 weeks to measure perceived stress and treatment-related symptoms. Primary outcome is change in Perceived Stress Scale scores; secondary outcomes include anxiety, depression, sleep disturbance, fatigue, and multiple symptomatic adverse events using the PRO-CTCAE. The intervention is delivered entirely online and excludes patients with current meditation practice or disease recurrence.
Who should consider this trial
Good fit: Women aged 18 or older with non-metastatic breast cancer who plan to start neoadjuvant or adjuvant chemotherapy within four weeks and have internet access and availability for a 6-week online program are ideal candidates.
Not a fit: Patients with recurrent or metastatic disease, those already practicing meditation or mindfulness, or those unable to read/write or access the internet are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the program could lower perceived stress and improve symptoms such as anxiety, insomnia, and pain during chemotherapy.
How similar studies have performed: In-person MBSR has shown benefit for stress and quality-of-life in cancer populations, but evidence for online MBSR specifically in patients undergoing chemotherapy is more limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Pedro Garza García, Nuevo León
- Hospital Zambrano Hellion — San Pedro Garza García, Nuevo León, Mexico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.