Clinical trial NCT04727593: The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Internet
Extracellular vesicles
Distress
Mindfulness
Mindfulness Based Cognitive Therapy
Anxiety
Depression
Biomarkers
eHealth
Telehealth
Lead sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto
Sponsor class: OTHER
Collaborators: name: European Commission
name: University of Coimbra
name: VTT Technical Research Centre, Finland
name: University of Oulu
name: Linnaeus University
First posted: 2021-01-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT), mindfulness-based cancer recovery (MBCR), have been showing promising results in different health-related and psychosocial outcomes in the context of cancer. More recently, the possibility of delivering MBIs using technological tools and resources, such as internet and applications, has been receiving much attention, also accompanied by promising findings. However, few randomized controlled studies have been conducted and published to date. Moreover, few studies have addressed the long-term stability and trajectory of gains across time. Also, even though prior evidence had suggested that face-to-face MBIs might modulate several biological markers (e.g., pro-inflammatory gene expression and inflammatory signaling; telomere length), as far as we know, no previous study addressed the impact of online MBIs on biological indices, especially on extracellular vesicles (EVs).

As primary objective, this study aims to investigate the effects of an internet-based MBCT intervention (vs. Treatment as Usual - TAU) on EVs (objective measure), as well as on psychological distress (subjective measure), considering a sample of distressed people with history of breast, prostate, and colorectal cancer.

As secondary objective, this study aims to investigate the effects of this same intervention on psychosocial outcomes, including quality of life, fear of cancer recurrence, emotion suppression, mindfulness, sleep quality, posttraumatic growth, health-related behaviours (physical activity; smoking habits), and perceived social support. The biological secondary outcomes studied will be: inflammatory response genes interleukins (ILs, IL-1, IL-6, IL-8, IL-10), interferon gamma (IFN-γ), tumour necrosis factor (TNF), and c-reactive protein (CRP); telomerase activity; antigens related to cancer (cancer antigen - CA 15-3; prostate-specific antigen - PSA; carcinoembryonic antigen - CEA); other health-related markers (adrenocorticotropic hormone - ACTH; erythrocytes number; hemoglobin glycosylated).


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.

Primary outcomes:
measure: Change on Extracellular Vesicles
timeFrame: T1 - before intervention; 8 weeks after T1; 24 weeks after T1
measure: Change on Distress
timeFrame: T1- before intervention; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Secondary outcomes:
measure: Change on Cancer antigen 15-3 (CA 15-3)
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Prostate-specific antigen (PSA)
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Carcinoembryonic Antigen (CEA).
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Adrenocorticotropic Hormone (ACTH).
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Transcript inflammatory response genes (Interleukins, ILs, IL-1, IL-6, IL-8, IL-10, IFNγ and TNF).
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Analytic biomarkers (Erythrocyte number).
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Analytic biomarkers (PCR number).
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Analytic biomarkers (telomerase activity).
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Analytic biomarkers (hemoglobin glycosylated).
timeFrame: T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline
measure: Change on Global distress
timeFrame: T0 - Screening; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on quality of life
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on fear of cancer recurrence
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on satisfaction perceived social support
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on emotional suppression
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on mindfulness abilities
timeFrame: T1 Baseline; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change Interview
timeFrame: T3 - 8 weeks after baseline
measure: Change on smoking dependency
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on physical activity
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on sleep quality
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
measure: Change on posttraumatic growth
timeFrame: T1 - Baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Study officials:
affiliation: Institute of Oncology of Porto, Portugal
name: Rui Henrique, PhD
role: STUDY_DIRECTOR
affiliation: Institute of Oncology of Porto, Portugal
name: Carmen Jerónimo, PhD
role: STUDY_DIRECTOR
affiliation: Institute of Oncology of Porto, Portugal
name: Eunice Silva, PhD
role: STUDY_DIRECTOR
References:
citation: Pereira DR, Silva ER, Carvalho-Maia C, Monteiro-Reis S, Lourenco C, Calisto R, Teixeira RJ, Carlson LE, Bart G, Vainio SJ, Sales MGF, Jeronimo C, Henrique R. The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study. Trials. 2022 Feb 5;23(1):118. doi: 10.1186/s13063-022-06045-x.