Online mindfulness therapy for cancer patients

The Modulatory Role of Internet-supported Mindfulness-based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Study Protocol for a Two-armed Randomized Controlled Trial

This study tests whether online mindfulness therapy can help reduce stress and improve health for cancer patients who have finished their main treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 111 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto (Academic / other)
• Drugs / interventions: trastuzumab
• Locations: 1 site (Porto)
• Trial ID: NCT04727593 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of internet-based mindfulness-based cognitive therapy (MBCT) on cancer patients, specifically focusing on its impact on distress levels and biological markers such as extracellular vesicles. Participants will include individuals diagnosed with breast, prostate, or colorectal cancer who have completed primary treatments and are experiencing significant distress. The study aims to compare the outcomes of MBCT with standard treatment practices. By utilizing digital platforms, the research seeks to explore the feasibility and effectiveness of delivering mindfulness interventions remotely.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of breast, prostate, or colorectal cancer, who have completed primary treatments and are experiencing significant distress.

Not a fit: Patients with severe psychiatric conditions, autoimmune disorders, or those currently using antipsychotics or anti-inflammatory medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce distress and improve overall well-being in cancer patients through accessible mindfulness interventions.

How similar studies have performed: While there is emerging evidence supporting the efficacy of mindfulness interventions in cancer care, this specific approach using internet-based MBCT is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of breast, prostate, or colorectal cancer;
* Cancer stage I - III;
* Primary cancer treatments completed between 3 months and 5 years (participants with ongoing adjuvant hormonal therapies will be included);
* Age between 18 and 65 years;
* Experiencing significant distress on the Distress Thermometer (DT ≥ 4)
* Willingness to accept randomization to one of the two study conditions and to attend the study for its duration;
* Ability to speak, read, and write in Portuguese and literacy to complete autonomously the self-report measures;
* Sufficient digital literacy with access to a device (e.g., smartphone; tablet; computer) with camera, microphone, and internet.

Exclusion Criteria:

* Concurrent diagnosis of severe psychiatric condition(s) (e.g., psychosis; substance abuse; bipolar disorder; suicidal ideation);
* Concurrent diagnosis of autoimmune disorder;
* Current use of antipsychotics;
* Current use of anti-inflammatory medication (corticotherapy);
* Undergoing trastuzumab therapy;
* Participation in a structured mindfulness program (e.g., MBCT; MBSR; Mindfulness-Based Cancer Recovery - MBCR) program in the past five years;
* Currently attending psychological consultation;
* Being pregnant or breastfeeding.

Where this trial is running

Porto

• Instituto Português de Oncologia do Porto Francisco Gentil, EPE — Porto, Portugal (Recruiting)

Study contacts

• Study coordinator: Eunice Silva, PhD

Conditions Cancer; Internet; Extracellular vesicles; Distress; Mindfulness; Mindfulness Based Cognitive Therapy; Anxiety; Depression