The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol

NCT04727593 | Unknown

• 1 other identifier: IPO/PI134b
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Keywords

Cancer; Internet; Extracellular vesicles; Distress; Mindfulness; Mindfulness Based Cognitive Therapy; Anxiety; Depression; Biomarkers; eHealth; Telehealth

Outcome Measures

Primary Outcomes (2)

• Change on Extracellular Vesicles

  Isolated by ultracentrifugation with sucrose cushion. The collected EVs will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL).

  T1 - before intervention; 8 weeks after T1; 24 weeks after T1

• Change on Distress

  Measured with Depression Anxiety Stress Scales-21 - DASS-21, a self-report and public domain questionnaire that evaluates negative affective states. It is composed of 21 items, 7 focused on depression, 7 on anxiety, and 7 on stress. Each item is rated on a 4-point Likert-type scale, wherein in 0 represents "did not apply to me at all" and 3 represents "applied to me very much or most of the time". The score for each subscale ranges between 0 and 21. In the current study, a total score will be computed by summing all items, with higher scores being indicative of higher self-reported psychological distress.

  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 (20)

• Change on Cancer antigen 15-3 (CA 15-3)

  T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline

• Change on Prostate-specific antigen (PSA)

  T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline

• Change on Carcinoembryonic Antigen (CEA).

  T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline

• Change on Adrenocorticotropic Hormone (ACTH).

  T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline

• Transcript inflammatory response genes (Interleukins, ILs, IL-1, IL-6, IL-8, IL-10, IFNγ and TNF).

  T1- before intervention; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline

Study Arms (2)

Mindfulness Based Cognitive Therapy (MBCT)

EXPERIMENTAL

Group intervention on Mindfulness-Based Cognitive Therapy classic program plus 4 monthly consolidation sessions of 90 minutes each.

Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

Treatment as Usual (TAU)

OTHER

TAU will be the control condition.

Other: Treatment as Usual

Interventions

Mindfulness Based Cognitive Therapy (MBCT) BEHAVIORAL

Experimental group: MBCT is program developed by Zindel Segal, Mark Williams, and John Teasdale , based on Jon Kabat-Zinn's Mindfulness-based Stress Reduction (MBSR) program. Participants learn to acknowledge their unhelpful thoughts and feelings, allowing the mind to move from an automatic and spiraling thought pattern to a more conscious emotional processing. Mindfulness practices include breath awareness, sitting and walking meditations, and mindful yoga. In this study, the following MBCT structure will be followed: group setting of 12 participants (maximum); 8 online weekly meetings of 2 hours via a videoconference platform (e.g., Cisco Webex), each one mediated by a trained mindfulness instructor(s); daily home practice of the learned skills; 2 hours of retreat after the fifth week; 6 months of home practice; 4 monthly consolidation sessions of 90 minutes each.

Mindfulness Based Cognitive Therapy (MBCT)

Treatment as Usual OTHER

In this case, participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral, and intervention for people with significant distress difficulties. Regarding pharmacological intervention, medication intake will be monitored during the study and changes will be registered. The engagement in non-pharmacological interventions such as psychological and psychosocial interventions will also be monitored.

Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Portugues de Oncologia, Francisco Gentil, Porto: lead
• European Commission: collaborator
• University of Coimbra: collaborator
• VTT Technical Research Centre, Finland: collaborator
• University of Oulu: collaborator
• Linnaeus University: collaborator

Study Sites (1)

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072, Portugal

RECRUITING

Related Publications (1)

• 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.

  PMID: 35123569 DERIVED

Related Links

• MindGAP project website

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rui Henrique, PhD

  Institute of Oncology of Porto, Portugal

  STUDY DIRECTOR

• Carmen Jerónimo, PhD

  Institute of Oncology of Porto, Portugal

  STUDY DIRECTOR

• Eunice Silva, PhD

  Institute of Oncology of Porto, Portugal

  STUDY DIRECTOR

Central Study Contacts

Eunice Silva, PhD

CONTACT

00351 961761035; esilva@ipoporto.min-saude.pt

Carmen Jerónimo, PhD

CONTACT

00351 225084000; carmenjeronimo@ipoporto.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: At baseline, everyone (participants, study coordinator, mindfulness instructor(s), research assistant, and statistician) will be blinded to conditions as it is expected to occur before randomization. Once participants are randomized, the study coordinator will inform them of the group assignments, and all of them will become unblinded to the conditions. Due to the specificities of this type of study and intervention, it is not possible to guarantee the blinding of personnel and participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 27, 2021
• Study Start: September 3, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

PT (1)