Mind Programme for Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The Mind programme for cancer patients was developed by this project's PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in depressive symptoms and anxiety severity, cancer-specific quality of life and psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.

Official Title
-----------------
Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Behavioral: Mind
* Behavioral: Support Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary diagnosis of breast cancer (stages between I and III); able to understand and respond to self-report questionnaires. Exclusion Criteria: currently undergoing any form of psychological intervention; current diagnosis of severe psychiatric illness (severe depression, psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation; diagnosis of neurological disease; pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The Mind programme is an ACT, mindfulness and compassion intervention for women with breast cancer. It will include 8 weekly group sessions, with the duration of 120 minutes each, and will be delivered at the Radiotherapy Service of the CHUC. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis. | Behavioral: Mind<br>* The Mind programme is an intervention based on Acceptance, mindfulness and compassion for women with breast cancer.<br>|
| Active Comparator: Control Group<br>A 8-week support group intervention will be delivered to the active control group. All participants will continue on receiving the recommended medical treatment for their clinical diagnosis. | Behavioral: Support Group<br>* To promote sharing of cancer-related experiences, active listening, and a sense of community between participants.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Cancer-specific quality of life, functioning, and symptoms at 6 months (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Fayers, Aaronson, & Bjordal, 2001) | The EORTC QLQ-C30 is a 30- item questionnaire that reflects the multidimensionality of the quality of life (QoL) construct which comprises: five functional subscales (physical, role, cognitive, emotional, and social); a global health/QoL subscale; three symptom subscales (fatigue, pain, and nausea/vomiting); and single items for the assessment of additional symptoms commonly reported by cancer patients (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea); and one more item related to the perceived financial impact of cancer and cancer treatment. All the items scales are scored on 4-point Likert type scales ranging from 1 'not at all' to 4 'very much', except the two items of the global health/QoL subscale, that use a modified 7-point linear analogue scales. The breast cancer-specific QLQ-BR23, a 23-item questionnaire, additionally assesses body image, sexual function, sexual enjoyment, and future perspective. | Baseline, post-treatment (2 months after baseline), and 6-months follow-up | 
| Change from baseline Depressive symptoms and anxiety severity at 6 months (Hospital Anxiety and Depression Scale - HADS; Zigmond & Snaith, 1983). | The HADS is a well-known instrument that comprises two subscales, one measuring anxiety (7 items) and one measuring depressive symptoms (with 7 items), which are scored separately. Each item is rated a 4-point scale (from 0 to 3). The HADS has presented Cronbach's alphas between 0.63 and 0.93 in the anxiety subscale, and between 0.67 and 0.90 in the depression subscale. In the Portuguese validation study, the anxiety and depression subscales had Cronbach's alphas of 0.76 and 0.81, respectively. | Baseline, post-treatment (2 months after baseline), and 6-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Psychological flexibility at 6 months (Comprehensive Assessment of Acceptance and Commitment Therapy Processes (18-item version) - CompACT; Francis et al., 2016) | CompACT is a measure of psychological flexibility, as conceptualized by Acceptance and Commitment Therapy. This scale comprises three subscales: Openness to experience, Behavioural Awareness, and Valued Action. Items are rated on a 7-point Likert scale (0-Never true to 6-Always true). The Portuguese study of the CompACT optimized the scale by reducing the number of items to 18 and presented Cronbach alpha values above 0.80 for the total scale and each subscale. | Baseline, post-treatment (2 months after baseline), and 6-months follow-up | 
| Change from baseline Self-compassion at 6 months (Self-Compassion Scale short form - SCS; Neff, 2003] | The SCS is a 26-item questionnaire that assesses self-compassion in a 5-point Likert scale (1 = Almost Never; 5 = Almost Always). The scale comprises a 6-factor structure: self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification, and usually presents Cronbach's alphas above 0.80. | Baseline, post-treatment (2 months after baseline), and 6-months follow-up | 
| Change from baseline Immunological and epigenetic markers at 6 months | The immunological response markers will comprise inflammatory biomarkers formerly associated with depression and anxiety (CRP, IL-6 and TNFalpha), biomarkers of the development of effective immune surveillance (e.g., IFNgamma, IL-12/18, GM-CSF), and suppressive cytokines that may block development of effective anti-tumour immune responses (e.g., IL-10, IL-4/13). Epigenetics markers will include miRNA expression of miR-21, miR-146a, miR-155, and miR-Let-7. | Baseline and 6-months follow-up | 
| Change from baseline EuroQol-5D-5L questionnaire at 6 months (EQ-5D-5L; EuroQol Research Foundation, 2019) | The EQ-5D-5L essentially consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | Baseline, post-treatment (2 months after baseline), and 6-months follow-up | 
| Major life events questionnaire (MLEQ; Trindade & Ferreira, 2017) - controlling variable | This checklist assesses the occurrence of major life events in the previous 12 months. The MLEQ was based on the Psychological-Stress Index (Cohen, Tyrrel, & Smith, 1991), and comprises 22 items that represent major life events that may happen in one´s life (e.g., marriage, divorce, pregnancy, interpersonal conflict, being robbed, death of a significant other). For each item, participants are asked to report the occurrence or absence of the specific event in the previous 12 months. The original version of the questionnaire is in Portuguese. | 6-months follow-up | 
| ACT processes (Hexa(in)Flex Interview) | Hexa(in)Flex Interview is a semi-structured interview that aims to assess qualitatively the subjective experience of the 6 core processes of the Psychological (In)Flexibility Model underlying ACT in women with breast cancer. The interview has two parts: 1) an introduction to the aims of the interview, as well as introductory questions regarding diagnostic information (e.g., duration of diagnosis, treatment phase, support network) and general coping and adaptation to the cancer diagnosis; 2) Five sections of open questions aiming to assess: experiential avoidance versus acceptance, cognitive fusion versus defusion, conceptual versus contextual self, Past and future conceptualized (auto-pilot) versus contact with present moment, and lack of values clarity and action versus commitment to valued action. Each section has instructions on how the interviewer should conduct the questioning, as well as additional tips and caveats that should be considered. | Baseline | 
| Change from baseline Consumption of resources and costs in breast cancer at 6 months | This questionnaire assesses the consumption of resources and economic costs associated with breast cancer. | Baseline, post-treatment (2 months after baseline), and 6-months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Compassion Focused Therapy, Acceptance and Commitment Therapy, biological markers, cost-effectiveness, mental health