Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants who agreed not to participate in any of the interventions proposed.

Hatha-yoga intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by Hatha-yoga trained teachers. This program was developed previously in Montreal and the following were included at each session: 1) preparatory warm-up synchronized with breathing; 2) selected postures (e.g. forward , backward-, and side-bending asanas in sitting and lying positions); 3) deep relaxation; 4) alternate-nostril breathing or pranayama; and 5) meditation. Each participant received a DVD to encourage at-home practice.

Yoga intervention

Hypnosis intervention included 6 sessions of 2 hours every 2 weeks. This was led by an anesthesist with experience in oncology and trained in hypnosis. Based on years of consultation with cancer patients, her team created a negotiating approach that fosters shared decision-making through using tasks that are centered on general well-being rather than on the health problem itself. Patients were asked to be actively involved. Several topics are addressed through tasks: eg. adjusting self-expectations. Patients were also required to keep a work-diary that was reviewed at the beginning of each session. At the end of the session, a 15-min hypnosis exercise is conducted. They receive CDs containing the hypnosis exercises and homework assignments.

Hypnosis intervention

CBT intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by CBT-trained psychologists with experience in psycho-oncology. This program was developed by team leaders and is modelled on the work of Andersen et al. (2008) and Savard (2010). The intervention targets were: 1) breast cancer, meaning of illness, understanding stress and responses to it; 2) impact of treatment on body image; 3) impact of treatment on self-esteem; 4) fear of recurrence; 5) relationships with relatives and health professionals; and 6) life projects, return to daily activities and work. Relaxation training took place at the end of each session and participants performed tasks between sessions.

CBT intervention

Guy Jerusalem, Prof.

This is a clinical non-randomized prospective study. This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer, at three times after the end of the interventions (just after the end, at a 3-month and at a 9-month follow-up).

This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (cognitive-behavioral therapy, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer.

Eligible breast cancer patients were identified through an institutional database or by referring physicians and were approached by phone to inform them of the intervention. They were given a choice between the three group interventions: CBT, yoga and self-hypnosis. Patients who agreed not to participate in any of the interventions were included in the control group. After giving written informed consent, patients completed a baseline assessment including self-reported measures. Follow-up assessment was conducted one week after the group intervention, and at a 3-month and 9-month follow-up. Interventions were proposed according to previous results showing the patient's interest in CBT, yoga and self-hypnosis, and the expertise of the team. Each intervention included 6 sessions of 1.5 hours.

The primary outcome measure was the interest in the three interventions (participation rate in each group). Since the study was first designed to determine interest, no sample size calculation was performed. Secondary outcomes were responses concerning emotional distress, QoL, sleep quality and mental adjustment to cancer assessed with self-reported questionnaires before and after the group interventions.

Descriptive statistics (percentages, means and standard deviation (SD)) were used to describe the proportions of patients who were interested in the group interventions and to examine their demographic, medical and psychological data. Baseline time 0 demographic, medical and psychological data were compared between groups to test for initial group equivalency using inferential statistics: analysis of variance (ANOVA) and Chi-square test, as appropriate. To be considered for the data analysis, patients had to attend at least three sessions. Multivariate analyses were calculated regarding group interventions and time of medical treatments (during or after chemo/radiation therapy). The pre- and post-assessment comparison of each measure within each group was made using the Wilcoxon test for matched pairs. All statistical tests were two-tailed, and a P-value \<0.05 was considered statistically significant. Investigators also calculated Cohen's d effect size for each group. The analyses were performed with SPSS Version 21.0 (IBM Corp., Armonk, N.Y).

Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being

Feasibility and Impact of Yoga, Self-hypnosis and Cognitive-behavioral Group Interventions in Improving Well-being of Breast Cancer Patients

The first outcome is to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate in each group (N and %).

The second outcome is to determine the reasons for choosing a particular group (open question).

The third outcome is to determine the reasons for declining to participate to the groups (open question).

This outcome is measured with the Hospital Anxiety Depression Scale (HADS) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up. The HADS is a reliable and validated 14-item measure assessing anxiety and depression in physically ill subjects \[27\]. Seven items for anxiety and 7 for depression are rated on a 4-point Likert scale (0=symptom not present to 3=symptom considerable). Each subscale is scored from 0 to 21 (0-7: 'normal range', 8-10: 'borderline', 11-21: 'probable presence of anxiety or depressive disorder').

This outcome is measured with European Organization for Research and Treatment of Cancer-Quality of Life Core Questionnaire-30 (EORTC-QLCQ30) and the Breast-cancer specific module (BR23) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up.

This outcome is measured with the Mental Adjustment to Cancer Scale (MAC) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up. This is a 40-item questionnaire addressing reactions of patients on having cancer. Items are given as statements, and patients assess their agreement using a 4-point Likert-scale ('definitely does not apply to me' to 'definitely applies to me'). There are five subscales: Fighting Spirit (cut-off ≥47); Helplessness/Hopelessness (cut-off ≥11); Anxious Preoccupation (cut-off ≥25); Fatalism (cut-off ≥22) and Avoidance (cut-off ≥3); and two general subscales: Summary Positive Adjustment Scale (cut-off ≥47) and Summary Negative Adjustment Scale (cut-off ≥36).

This outcome is measured with the Insomnia Severity Index (ISI) at 4 time periods: before and just after the intervention, at a 3-month and a 9-month follow-up. This is a 7-item measure of subjective sleep complaints and associated distress. Items are scored on a 5-point Likert scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The cut-off scores are 0-7 (no clinically significant sleep difficulties), 7-14 (sleep difficulties warrant further investigation) and 15+ (presence of clinically significant insomnia).

University of Liege

Ph.D.

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Anxiety Disorders

Depressive Disorder

Prostatic Neoplasms

Depression

Stress, Psychological

Group therapy based on Mindfulness Based-Cognitive Therapy (MBCT).

Group therapy based on Emotion Focused Therapy for Cancer Recovery (EFT-CR).

Treatment as Usual is the condition in which participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral and intervention for people identified with significant distress difficulties.

MBCT is a program developed by Zindel Segal, Mark Williams and John Teasdale. During MBCT patients learn to decenter their negative thoughts and feelings, allowing the mind to move from an automatic thought pattern to conscious emotional processing. Mindfulness practices included in this program are breath awareness, body scan, sitting and walking meditation, and mindful yoga. The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.

Mindfulness Based-Cognitive Therapy (MBCT)

EFT-CR is an evidence-based approach to psychotherapy, which combines aspects of person-centered, gestalt and existential therapies with contemporary emotion theory and dialectical constructivism (Elliott et al, 2004, Rice \& Greenberg, 1984). On EFT-CR, therapist follows the client experience and guides the process, proposing therapeutic tasks when specific client behaviors occur. EFT-CR uses a set of emotion change principles which guide a process of emotional deepening process, from undifferentiated distress to secondary reactive emotions to primary maladaptive emotions to core pain and thence to primary adaptive emotions and emotional transformation (Elliott \& Greenberg 2016). The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.

Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)

Treatment as usual (no intervention)

Eunice Silva, PhD

Carmen Jerónimo, PhD

Rui Henrique, PhD

Goreti Sales, PhD

Background: There is some evidence demonstrating the effect of psychological interventions in improvements in health biological parameters. To best of our knowledge, no study had addressed the impact of any psychological intervention on extracellular vesicles. In addition, Mindfulness-Based Cognitive Therapy (MBCT) and Emotion Focused Therapy for Cancer Recovery (EFT-CR) in the group have never been explored regarding extracellular vesicles and the effectiveness of these was not compared yet.

Objectives:

1. To explore and compare the effect of MBCT and EFT-CR on biological parameters and psychological variables in distressed people who have had breast, prostate and colorectal cancer;
2. In addition, we will explore the acceptability through recruitment and retention rates of MBCT and EFT-CR in group and evaluate whether these interventions are appropriate for a larger clinical trial.

Methods: The design of this study is a parallel randomized controlled trial. Participants will be randomized into MBCT, EFT-CR or usual care. Outcome measures will be assessed before, at the end of the intervention (8 weeks) and follow-ups (24 and 52 weeks from the baseline moment).

Hypotheses: The researchers expected that both interventions will have an effect on extracellular vesicles and other study biomarkers as well as improvements in psychological outcomes, compared to treatment as usual (TAU) group. Regarding the comparative effectiveness, we did not have evidence to hypothesize which one of the interventions will be superior in both biological (extracellular vesicles) and psychological outcomes.

Contribution for practice: The results of this preliminary study would permit to know if there are benefits of these psychological interventions on changes in extracellular vesicles and on psychological outcomes related to health. In addition, this study will permit to determine the acceptability of conducting a larger randomized controlled trial.

only the investigator responsible for the eligibility assessment would be blind (in the recruitment, in order to assess eligibility to enter the study), before the randomization.

Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer

Impact of Mindfulness-Based Cognitive Therapy and Emotion Focused Therapy Group for Cancer Recovery Interventions on Extracellular Vesicles and Psychological Distress in People Who Had Breast, Colorectal or Prostate Cancer: A Preliminary Parallel Randomized Controlled Trial

The collected extracellular vesicles will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL). NTA measures Brownian movements on a particle-by-particle basis tracking movements by image analysis. Additionally, miR21-5p - a brain related microRNA - will be measured to ascertain for the extracellular vesicle's origin. The latter will be achieved by isothermal DNA amplification method, and data will be measured by luminescence (in RLU - relative light unit).

This self-report instrument assess the depressive, anxiety and stress symptoms in a 4-points likert scale, from 0 to 3, with higher values representing higher depression, anxiety and stress symptoms

This indicator assess CA 15-3 (units/mL) using an immunoassay analyzer

This indicator assess PSA (ng/mL) using an immunoassay analyzer

This indicator assess CEA (ng/mL) using an immunoassay analyzer

This indicator assess ACTH (pg/mL) using an immunoassay analyzer

These indicators assess inflammatory response genes in plasma by Quantitative RT-PCR assays of the same individuals using TaqMan™ Gene Expression Assays

This indicator assess erythrocytes number (million/mm3) from blood samples(Sysmex XN)

This indicator assess PCR (mg/L) from blood samples

This indicator assess telomerase activity (units) from blood samples

This indicator assess HPLC (mmol/mol) from blood samples

This self-report measure assesses global distress in four domains: subjective well-being, symptoms, social/life functioning, risk to self and others, rated in 5-points likert scale from never to always. Higher scores meaning higher psychological suffering

These self-report instrument assess perceived quality of life related to the cancer, in a 5-points likert scale, from 0 to 4, with higher value indicated higher quality of life

These self-report instruments assess perceived spiritually related to the cancer in a 5-points likert scale, from 0 to 4, with higher value indicated higher well-being

This self-report instrument assess the fear of cancer recurrence, rated in a 5-points likert scale, with higher values indicated higher fear of recurrence

This self-report instrument assess the perceived level of social support, rated in a 5-points likert scale, with higher values meaning higher social support

This self-report measure assess the emotion regulation processes rated in a 7-points likert scale, with higher values representing higher emotional suppression

This self-report measure assess the impact of significant events, rated in a 5-points likert scale, with higher scores meaning higher negative impact of the event

This self-report measure assess the mindfulness and awareness skills, rated in a 6-points likert scale with higher scores indicating higher attention and awareness

This self-report measure assess the self-compassion skills, rated in 5-points likert scale, with higher scores indicating higher self-compassion

This interview assesses the psycho-therapeutic changes perceived by participants after psychological intervention. The interview questions explore the changes that a person has noticed since therapy began, what the person attributes these changes to, and helpful and unhelpful aspects of therapy, in a qualitative way. In addition, the participants identified therapeutic changes as result of the therapy and are asked to rate these changes in three scales: expected change (1: change totally expected; 5: totally unexpected); change without therapy (1: the change would not have happened; 5: change would happen for sure); and the value of the change (1: nothing important; 5: extremely important).

This instrument assesses nicotine dependency with 6 items (rated from 0 to 2 or 3). The total score range is 1-10, with higher values meaning higher nicotine dependency

This instrument assesses physical activity in 7 items, with higher scores meaning higher level of physical activity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being	NCT02569294	Breast Cancer	Yoga interventi... Hypnosis interv... CBT interventio...	18 Years - 75 Years	University of Liege
Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer	NCT04298398	Cancer	Mindfulness Bas... Emotion Focused... Treatment as us...	18 Years - 65 Years	Instituto Portugues de Oncologia, Francisco Gentil, Porto

Spots Global Cancer Trial Database for group interventions