Nervous System Diseases

Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Rare Diseases

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Chronic Graft Versus Host Disease

A 6-week online cognitive-behavioural treatment for insomnia. Each week focuses on a different topic consistent with the cognitive-behavioural theory of insomnia.

The online attention matched control arm will provide education about sleep without any focus on the active ingredients that constitute the intervention group.

psychoeducation about insomnia, relaxation training, sleep restriction, stimulus control, hypnotic tapering under direction of a physician, cognitive therapy, sleep hygiene

Cognitive Behavioural Therapy

Cheryl Harris

Chronic insomnia affects more than 25% of cancer survivors, a rate double that of the general population. The Pan-Canadian sleep guideline for adults with cancer recommends Cognitive-Behavioral Therapy for Insomnia (CBT-I) as the best treatment. Major problems, however, are the lack of available CBT-I at cancer centers and the lack of information about possible side-effects of CBT-I. To address this issue, our study will evaluate the effectiveness and potential short-term side-effects of an online version of CBT-I. It is expected that when compared to cancer survivors who receive an online sleep education program, those who receive online CBT-I will experience improved sleep, mood, and quality of life, as well as reduced anxiety and fatigue.

Insomnia is a common adverse effect of cancer and its treatment. More than 25% of cancer survivors meet diagnostic criteria, a rate at least two times higher than that of the general population. Despite the pervasiveness of the problem, insomnia is underdiagnosed and undertreated in cancer survivors, resulting in significant suffering and associated consequences such as fatigue, cognitive issues, mood disturbance, functional disability, decreased quality of life, and immunosuppression. Consistent with recent evidence that group cognitive behavioral therapy for insomnia (CBT-I) is effective in treating insomnia in cancer survivors, CBT-I is recommended as first line treatment in the new Pan-Canadian practice guideline for sleep disturbance in adults with cancer. A major barrier to practical application of this recommendation however, is the lack of appropriately trained professionals at cancer centres. Moreover, it is assumed that in contrast to pharmacotherapy, CBT-I is free of treatment-related side-effects; however, we have no knowledge of symptoms that may be experienced by cancer survivors and/or exacerbated during CBT-I treatment (e.g., increased fatigue, cognitive impairment) because such effects are not systematically monitored. With the goal of improved access to CBT-I, online versions have been developed. One initial evaluation has been conducted in cancer patients with promising results, although limitations of the study include a small sample size (n = 28), control condition that failed to match for modality and time, lack of follow-up data, and failure to investigate potential side effects during treatment. Further inquiry is clearly warranted and consistent with insights of Canadian cancer patients who have suggested the use of technology as a factor that would facilitate their participation in an insomnia treatment program.

Specific research questions to be addressed in our proposed two-group, randomized, controlled trial include: 1) Do cancer survivors with chronic insomnia who receive a 6-week, internet-based CBT-I treatment have greater improvement in insomnia severity and other secondary sleep and quality of life outcomes, than participants in an online sleep education control group? 2) Are there short-term side-effects associated with CBT-I for cancer survivors (i.e., do participants get worse before they get better)?

Adult outpatients diagnosed with any type of cancer (stages I-III), completed active treatment for at least 1 month (with the exception of hormone therapy) and without cancer recurrence will be will be recruited from The Ottawa Hospital Cancer Centre and Cancercare Manitoba (n = 150). All will meet established diagnostic and research criteria for chronic insomnia. Prior to acceptance in the study, the procedures will be fully explained, inclusion/exclusion criteria assessed, and formal consent obtained. Once accepted into the study, participants will be randomized (stratified by hormone therapy-yes or no) to one of the two study arms. Online assessment measures (insomnia severity, pre-sleep arousal, beliefs about sleep, fatigue, mood, anxiety, quality of life) will be completed at the baseline period, at week 6 (post treatment), and at 3 month follow-up; however, online diary assessments of sleep parameters and potential side-effects (fatigue, affect, cognition, pain, drug dosing) will be entered daily and potential side-effects will also be assessed online weekly through the course of treatment. Analyses will involve mixed modeling and latent growth curve models.

The computerized intervention evaluated in this study has the potential to bridge an existing gap in knowledge translation by providing cancer survivors widespread access to CBT-I in a cost-effective manner. The study will also investigate potential short-term side-effects of online CBT-I so that patients can be fully informed when making treatment decisions. The online program could serve as the foundation of a stepped care model as recommended in the Pan-Canadian sleep guideline for adults with cancer. Overall, by reducing the burden of residual effects of cancer and its treatments, this research aims to enhance quality of life for cancer survivors in Canada and elsewhere.

The Effectiveness of Online Treatment for Insomnia in Cancer Survivors

The Effectiveness of Online Treatment for Insomnia in Cancer Survivors: A Randomized Controlled Trial

A psychometrically sound 7-item self-report measure of perceived sleep impairment. Each item is rated using a five-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28. The ISI was recently validated in a large, heterogeneous sample of cancer patients (Savard, Savard, Simard, \& Ivers, 2005).

A daily assessment of potential side-effects. The ESAS-R assesses symptoms including pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and wellbeing on a 0-10 scale. The 9-item measure created for this study includes the pain, drowsiness, depression, anxiety, and wellbeing items and adds fatigue, irritability, forgetfulness, and concentration in a format that otherwise resembles the ESAS-R.

A standardized daily outcome measure in insomnia research. Each morning respondents require 2-4 minutes to record a) the number of hours slept, b) time in bed, c) sleep onset latency (estimated time in minutes that it took to fall asleep after going to bed), and d) number of awakenings. All medications taken are also recorded. Diary data are used to calculate wake time after sleep onset (the amount of time in bed minus total sleep time and sleep onset latency) and sleep efficiency (the ratio of total sleep time to time in bed).

Comprises of 10 negative adjectives describing emotional states. Using a 5-point scale, respondents rate the extent to which each adjective is consistent with his or her current emotional state.

Self-reported current, worse, least, and average pain are each assessed. Good validity, reliability, sensitivity to change, and appropriateness to cancer pain have been reported (Jensen et al., 1999).

a 10-item self-report measure of maladaptive beliefs about sleep (e.g., beliefs about the immediate and long term negative consequences of insomnia, beliefs about the need for control over insomnia). Although developed as an analogue scale, it was transformed into a Likert-type scale with responses ranging from 1 (strongly disagree) to 6 (strongly agree). Thus, possible scores ranged from 10 to 60, with higher scores indicating more maladaptive cognitions regarding sleep. The DBAS has moderate reliability and validity (Edinger, Wohlegemuth, Radtke, Marsh, \& Quillian, 2001).

An 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal. Evidence of the internal consistency, test-retest reliability, and convergent validity have been reported by the authors in their initial publication.

It consists of 5 subscales, and the authors recommend using the general fatigue subscale for investigations of overall levels of fatigue. The general fatigue (GF) subscale has been found to have good internal consistency (ranging from 0.83-0.90), and GF subscale scores have been shown to positively and significantly correlate with other self-report measures of fatigue. Scores on the sub¬scale range from 4 to 20, with higher scores indicating greater fatigue. It is frequently used with cancer patients (Smets, Garssen, Cull, \& de Haes, 1996).

A 42-item self-report measure that can be reliably grouped into three scales: anxiety, depression, and stress; however, only the depression subscale will be included for the present study. The depression subscale has demonstrated high internal consistency (Cronbach's alpha = 0.96) in a clinical sample (Brown, Chorpita, Korotitsch, \& Barlow, 1997).

A brief, 5-item scale assesses patient's perspectives of impaired functioning in important life domains. The authors report a high level of internal consistency (Cronbach's alpha = .7-.94), good test-retest reliability and sensitivity to change with treatment. Subsequent studies have confirmed its psychometric properties (Mataix-Cols et al., 2006).

A 15 item measure of subjective stress in relation to a specific stressor (e.g., cancer). It has strong psychometric properties and is frequently used in cancer research (Cella \& Tross, 1986; Cella, Mahon, \& Donovan, 1990; Thewes, Meiser, \& Hickie, 2001). The four-point frequency scale is as follows: 0='not at all', 1='rarely', 3='sometimes', 5='often', allowing the calculation of a total score (with a possible range of 0-75) and separate intrusion and avoidance subscales scores (with a possible range of 0-35 and 0-40, respectively). Research in oncology suggests a score of ≥ 40 is indicative of a significant stress response (Cella, Mahon, \& Donovan, 1990).

A 5 item questionnaire designed to measure cancer specific concerns not covered in general quality of life measures. Each item is rated using a four-point Likert scale ranging from 1 (not at all) to 4 (very much). The first three questions load on a cancer-specific worry subscale and the last two measure general health worry. Evidence of internal consistency, convergent and discriminant validity have been demonstrated in the original article. A recent intervention study provides some evidence of its sensitivity to change (Hershman et. al., 2013).

Global Quality of Life Subscale (Aaronson, Ahmedzai, \& Bergman, 1993; Osoba et al., 1997) was developed and validated with cancer patients. The global quality-of-life scale, comprised of two items rated on a Likert-type scale with responses ranging from 1 (very poor) to 7 (excellent) will be used. Scores are transformed to provide a rating ranging from 0 to 100.

With acceptable internal consistency (Cronbach's alpha = .81) and construct validity, a modified version of the five-item Medical Outcomes Study General Adherence Scale (MOS-A; Kravitz et al., 1993) assesses compliance with treatment. The MOS-A was modified by replacing physician with psychologist, and sample items are "I followed my psychologist's suggestions exactly" and "I found it easy to do the things my psychologist suggested I do." Participants respond on a scale of 1 (none of the time) to 6 (all of the time). Total scores range from 5 to 30, with higher scores reflecting greater adherence. Scores on the MOS-A have been found to correlate with adherence to other types of regimes in areas of exercise and diet (DiMatteo et al., 1993), and to negatively correlate with barriers to treatment in the area of insomnia (Vincent, Lewycky, \& Finnegan, 2008).

A four item questionnaire to assess how confident participants are that the online program helped their sleep problem, if they plan to ask for further help (e.g., in person counseling), what they liked best about the program and what they would change to make the program better.

Assesses patients' perceived global improvement. The CGI asked patients to report the overall change in their sleep and in sleep-related effects as a result of participation in their treatment. Participants are asked to rate the change in their sleep and not in any other problem such as chronic pain, depression, or anxiety. Response choices rang from very much improved (1) to very much worse (7). Evidence of the construct validity of the CGI-self-report version comes from the demonstration that CGI scores are significantly and positively associated with treatment-related changes in sleep parameters (e.g., TST, SE) (Vincent, unpublished).

Canadian Cancer Society (CCS)

University of Manitoba

Ottawa Hospital Research Institute

Neoplasms

Digestive System Diseases

Anxiety Disorders

Depression

Depressive Disorder

Liver Neoplasms

Behavioral Symptoms

Mood Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Quality of Life

Hematinics

All Drugs and Chemicals

Liver Extracts

A specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format.

Participants will receive eight health education sessions simultaneously with the CBT-based intervention group.

A specifically designed CBT-based intervention consisting of 8 weekly sessions with group format.

Each group will be comprised of 4-10 participants, and each session will last 1.5 hours.

The content of the weekly sessions will be based on Beck's cognitive theory and the cognitive therapy in groups guidelines.

The framework of every session will follow a pre-determined structure.

Cognitive behavioural therapy-based intervention

The educational sessions are consisting of 8 weekly sessions with a group format. These sessions will focus on cancer-related information and care knowledge which will be delivered in daily routine care.

Educational group

Hua Yin

This study investigates the effects of a CBT- based intervention on depression, anxiety, immune function, quality of life, and overall survival. It also explores if the effects of the intervention on immune function and quality of life are mediated through the improvements in depression and anxiety among patients with liver cancer.

In the present research project, the investigators have developed a Cognitive Behavioral Therapy (CBT)-based intervention protocol to investigate the impact of this intervention on depression, anxiety, quality of life, immune function, and overall survival in patients diagnosed with liver cancer. Additionally, this research protocol aims to examine the hypothesized mechanisms underlying the effects of the CBT-based intervention on quality of life and immune function. Specifically, we will investigate: 1) whether the effect of the CBT-based intervention on quality of life is mediated by improvements in anxiety and depression, and 2) whether the effect of the CBT-based intervention on immune function is mediated by improvements in anxiety and depression among patients with liver cancer.

A total of 160 participants will be recruited and randomly assigned to either the CBT-based intervention group or an educational group receiving non-psychological interventions. Assessments will be conducted at baseline (pre-treatment) and at 3, 6, and 12 months after the intervention period. Survival data will be collected throughout the follow-up period until the patients' end-of-life.

By examining the effects of the CBT-based intervention on multiple outcomes and exploring the potential mediating mechanisms, this research project aims to contribute to a comprehensive understanding of the intervention's effectiveness and its impact on the well-being of liver cancer patients.

The study will be a parallel, multicenter, randomized controlled trial.

We will ensure that the assessors are unaware of the treatment assignments or intervention details for each participant. We will use anonymized coded data that does not reveal the group allocation during the outcome assessment. The data will be presented in a standardized format that prevents any identification of treatment groups.

Effects of CBT-Based Intervention Among Patients With Liver Cancer

Effects of Cognitive Behavioral Therapy-Based Intervention on Depression, Anxiety, Quality of Life, Immune Indicators, and Survival Among Patients With Liver Cancer

Participants' depression score with the depression subscale of the Hospital depression and Depression Scale (HADS). The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.

Change in participants' depression score with the HADS depression subscale from baseline to 3 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.

Change in participants' depression score with the HADS depression subscale from baseline to 6 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.

Change in participants' depression score with the HADS depression subscale from baseline to 12 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.

Participants' anxiety score with the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

Change in participants' anxiety score with the HADS anxiety subscale from baseline to 3 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

Change in participants' anxiety score with the HADS anxiety subscale from baseline to 6 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

Change in participants' anxiety score with the HADS anxiety subscale from baseline to 12 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.

The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.

Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.

Total lymphocyte count. Collected from daily medical records.

Level of IFN-γ. Collected from blood sample.

ZhuHai Hospital

The Nethersole School of Nursing

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Anti-Infective Agents

Central Nervous System Depressants

Micronutrients

Ethanol

Iron

Patients following the standard preoperative policies of opur institution

Patients following the standard preoperative policies of opur institution and the multimodal prehabilitation program

The standard preoperative measures will consist of a recommendation for physical activity and advice on tobacco smoking cessation and reduction of alcohol intake. In addition, patients who suffer from iron deficient anemia will receive intravenous iron and those at risk of malnutrition (Malnutrition Universal Screening Tool ≥2 (www.bapen.org.uk/pdfs/must/must_full.pdf)) or that require weight control for obesity (IMC≥30) will perform a nutrition intervention by a nutritionist.

Usual care

The experimental group will also carry out a prehabilitation program consisting in:

A. A motivational interview to reinforce the patient's motivation and generate a commitment in relation to the objectives of the program.

B. A physical activity promotion program to increase the number of daily steps of patients, measured by a wristband and a mobile App.

C. A supervised high-intensity exercise training program. D. An individualized nutritional optimization plan with dietary advice and protein supplementation (if necessary). Educational material and motivational messages will be sent through a mobile App.

F. Psychological support through weekly Mindfulness sessions (1.5 hours duration). Educational material and motivational messages will be sent through a mobile App.

E. A smoking cessation program consisting psycho-cognitive therapy combined with pharmacological treatment. Educational material and motivational messages will be sent through a mobile App.

Multimodal prehabilitation

Maria Sanchez

Anael Barberan-Garcia, PhD

This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.

This trial aims to assess the cost-effectiveness of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery. Secondary objectives are to evaluate the impact of the intervention on: i) Healthcare resuorces use; ii) clinical outcomes; and, iii) patient's and professionals experience with the program.

The program includes X main interventions: i) A motivational interview; ii) A high-intensity exercise training program; iii) A plan for physical activity incentivation; iv) A nutritional optimization program; v) A psicologichal support program; and, vi) A smoking cessation program.

Multimodal Prehabilitation in Thoracic Surgery

Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial

Number and severity of postoperative complications

Hospital readmissions during the first 30 days after surgery

Emergency room visits during the first 30 days after surgery

Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0-126 points (the higher, the better))

Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer

Physical status measured by the physical domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))

Mental status measured by the mental domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))

Anxiety and depression levels measured by the Hospital Anxiety and Depression (HAD) questionnaire (range 0-42 points (the lower, the better))

Fat free mass index measured by bioimpedance

Hospital Clinic of Barcelona

Principal investigator

Skin and Connective Tissue Diseases

Respiratory Aspiration

Breast Neoplasms

Breast Diseases

Skin Diseases

Standard guided imagery combined with Mindfulness and breathing technique will be applied. Additionally, the directives will be given to participants to imagine themselves swinging in a green peaceful environment where they will face no harm but healing and full of wellness. Every time they imagine their swing goes up, patient will be asked to physically take a deep breath (taking the breath will be physically (actually) done, not imagining), and when going down patient will be asked to physically release their breath (releasing breath will be physically (actually) done, not imagining).

Participants will receive a session of standard psycho-social care for anxiety (50 minutes length). The standard psycho-social care interventions involve the most well-known talking therapy approach of Cognitive Behavioural Therapy (CBT).

Participants will receive psycho-education about mindfulness and how it operates. That will also assist patients to warm up for the actual intervention. Then the actual swinging effect intervention will commence respectively.

Mindfulness based Swinging Effect Intervention

Jose M Maldonado, PhD, MSc

It is hypothesised to find that the new mindfulness intervention of Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer is an effective therapeutic intervention to be applied in breast cancer population. This intervention intended to support patients' management of their chronic illness (self-efficacy) by increasing their hope about their treatment and alleviate anxiety, as well as increase patient saturation level. Therefore, enabling patients to continue to their medical as well as psychological treatment will result improved anxiety, stress levels, hope and self-efficacy. It is known that mental health needs of cancer patients differ from people who do not suffer from a chronic illness.

Participation in this research is entirely voluntary. Participants are required to complete a semi-screening assessment form which asks socio-demographic and bio-medical information. This form is also assess participants eligibility to take part. Then will ask participants to complete the Hospital and Depression Scale (HADS), Self-Efficacy for Managing Chronic Disease (SEMCD), Beck's Hopelessness Scale (BHS), Emotion Thermometer (ET), State Trait Anxiety Inventory (STAI) before and after (pre-post) their allocated intervention (arm). Participants have the right to answer as many or as few questions asked as they wish. They also have the right to withdraw from the study up to four weeks after they have completed the required psychometric measurement tools. Should they wish to withdraw then they will need to inform the researcher by email, quoting their unique participation identification code which will be generated before beginning the study using their name initials and date of birth. This will enable researcher to identify all the materials that needs to be deleted due to their withdrawal from the project. Alternatively, if they decide that they no longer want to take part in the study they can notify the researcher/clinician immediately and their recorded information (if any) will be completely erased from the study. Other than answering a number of demographic questions (in order to establish the characteristics of the sample), participants will not be directly disclosing any confidential personal information. However, the survey completion data will be checked for any identifying information and anonymised if necessary. Participants will be allocated a code number, and this will be used when quoting from the data-set. The data will be kept confidential and stored in a safe locked cabinet/storage at all times. The ethical approval is obtained from one of the Turkish institution where they issue ethical approval in accordance with the ethical standards of the Helsinki declaration.

only biological gender will be considered

A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer

Efficacy of Mindfulness Based Swinging Technique (MBST) for Improving Anxiety, Stress, Hopelessness and Self Efficacy Among Breast Cancer Patients in Treatment

data results and outcome will be available to researchers once it is published on a journal.

To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to reduce stress and anxiety for breast cancer patients. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.

To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used right before and after the intervention. If two consecutive numbers are circled, the lower number will be coded (less self-efficacy). The score for the scale is the mean of the six items. If more than two items will be missing, scoring the scale will not happen. Higher number indicates higher self-efficacy.The higher values represent a better outcome for this scale.

To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used right before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.

To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used before and after the intervention. Each of the 6 items are rated from 1 (not at all confident) to 10 (totally confident). The overall score is derived from the mean of the 6 items. The total minimum score will be 6 (very low self-efficacy), and maximum total score will be 60 (very high self-efficacy). Higher scores indicate a better self-efficacy.

To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.

To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety State Trait Anxiety Inventory will be used before and after the intervention. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.

To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Emotion Thermometer will be used before and after the intervention. To calculate the Emotion Thermometer the fixed cut-offs will be used meaning that 0-3 (low) and 4-10 (high) on each component.

To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Hospital Anxiety and Depression Scale will be used before and after the intervention. To calculate Hospital Anxiety and Depression Scale the cut of scores are 0-7 considered in normal range, 8-10 considered in Borderline abnormal (borderline case) and 11-21 considered in Abnormal (case) respectively.

To observe whether breast cancer patients' education level has any impact on efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce anxiety and increase self-efficacy and hopefulness. The participants' education level will be obtained from self-reported socio-demographic semi-screening assessment form.

To observe whether breast cancer patients' marital status has any impact on efficacy of the Mindfulness Based Swinging Technique (MBST). The participants' marital status will be obtained from self-reported socio-demographic semi-screening assessment form.

To observe whether breast cancer patients' living arrangement has any impact on efficacy of the Mindfulness Based Swinging Technique (MBST). The participants' living arrangement status will be obtained from self-reported socio-demographic semi-screening assessment form.

To observe whether breast cancer patients' time for learning their cancer diagnosis has any impact on efficacy of Mindfulness Based Swinging Technique (MBST). The information of when participants have learnt their cancer diagnosis will be obtained from self-reported socio-demographic semi-screening assessment form.

To observe whether breast cancer patients' metastatic status has any impact on efficacy of Mindfulness Based Swinging Technique (MBST). The participants' metastatic status will be obtained from self-reported socio-demographic semi-screening assessment form.

University of Barcelona

Fatigue

Endurance training (walking on a treadmill) 3 x weekly for 4 weeks

Endurance exercise 3 times weekly for 45 minutes, 4 weeks long

Exercise

Teaching of techniques to reduce fatigue and to improve stamina

Cognitive behavioural therapy

Fernando Dimeo, MD

Susanne Effenberger

The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.

Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue

Charite University, Berlin, Germany

Herbal and Botanical

Nicotine

Varenicline

Cayenne

A contemporaneous control group of patients was build using propensity score matching (PSM) methodologies taking into account the following matching variables: type of surgery, age, sex, American Society of Anesthesiologists Index (ASA) and adjusted morbidity groups (GMA) grading.

Prospective sample of risk patients who are candidates for major surgery attended in the outpatient offices of the Hospital Clínic de Barcelona.

Inclusion criteria: i) American Society of Anesthesiologists Index (ASA) 3-4; and / or, ii) age ≥ 75 years; and / or iii) major aggressive surgery; and, iv) solid organ transplant candidate.

Exclusion criteria: i) Non-elective surgery; ii) Known metastatic disease before surgery; iii) Unstable respiratory or heart disease; or, iv) Locomotive or cognitive limitations that prevent adherence to the program.

The preoperative standard measures consist of physical activity recommendation and advice on both smoking cessation and alcohol intake reduction. Moreover, in patients presenting with anemia, the anesthesiologists will assess its etiology and treat it accordingly, and nutritional intervention will be performed by a registered dietitian in to those patients at risk of malnutrition (Malnutrition Universal Screening Tool ≥2).

i) Exercise training: Ambulatory exercise training sessions with two main components, namely: high-intensity endurance exercise training and strength muscular training.

ii) Promotion of physical activity: Pedometer-based program using a physical activity tracker linked to a mobile app.

iv) Nutritional optimization: Recommendations of a healthy balanced diet or adapted to their digestive symptoms. Daily amount of protein intake will be close to 2 g•Kg-1•day-1.

iv) Smoking cessation: Use of both cognitive behavioral intervention and pharmacological therapy by varenicline or nicotine replacement therapies.

v) Cognitive behavioral therapy: Weekly group sessions conducted by a clinical health psychologist, including psychoeducation, motivational and behavioral change, self-efficacy and adherence enhancement, coping strategies acquisition and patient empowerment.

Prehabilitation

Josep Roca, Prof

PAPRIKA establishes a technologically enabled and personalized prehabilitation and follow-up after surgical intervention program for patients undergoing elective major surgery Program creates close collaboration between the medical environment and the patients empowering them to co-create their own care.

It is at the first stage aimed to high-risk patients undergoing major surgery. Better condition before the surgery is proved to reduce the perioperative complications and to improve patients' health-related quality of life while cutting the associated costs. The concept integrates short-term (average 4 weeks) preoperative interventions including endurance training, promotion of physical activity and nutritional and psychological support. Interventions are planned both at community and at hospital reducing unnecessary interactions between patients and tertiary care.

PAPRIKA tackles three major drivers: i) human perspective ii) organizational challenges and iii) technical aspects. The project is based on previous experience on prehabilitation and the already refined service using design thinking methodologies. It will be also based on the proven reduction of associated costs for the healthcare system.

PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home

Distance covered during the six-minute walk test

Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0 to 142; the lowest the worst)

Psycho-emotional status measured by the Hospital Anxiety and Depression (HAD) scale (range 0-21; the highest the worst)

Number of postoperative complications during the initial hospitalization for surgery

Number of days of hospital length of stay during the initial hospitalization for surgery

Severity of postoperative complications during the initial hospitalization for surgery using the Clavien-Dindo classification

Number of postoperative complications during a 30-day period after surgery

Number of emergency room visits during a 30-day period after surgery

Number of surgical reinterventions during a 30-day period after surgery

Number of exitus during a 30-day period after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effectiveness of Online Treatment for Insomnia in Cancer Survivors	NCT02272712	Chronic Insomni...	Cognitive Behav...	18 Years -	Ottawa Hospital Research Institute
Effects of CBT-Based Intervention Among Patients With Liver Cancer	NCT05942560	Depression Anxiety Liver Cancer CBT	Cognitive behav... Educational gro...	18 Years -	The Nethersole School of Nursing
Multimodal Prehabilitation in Thoracic Surgery	NCT04052100	Lung Cancer	Usual care Multimodal preh...	-	Hospital Clinic of Barcelona
A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer	NCT03985267	Anxiety Stress Self Efficacy Depression Breast Cancer F... Hopefulness	Mindfulness bas...	18 Years -	University of Barcelona
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue	NCT01035203	Fatigue Mood Maximal Oxygen ...	Exercise Cognitive behav...	18 Years - 70 Years	Charite University, Berlin, Germany
A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer	NCT03985267	Anxiety Stress Self Efficacy Depression Breast Cancer F... Hopefulness	Mindfulness bas...	18 Years -	University of Barcelona
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue	NCT01035203	Fatigue Mood Maximal Oxygen ...	Exercise Cognitive behav...	18 Years - 70 Years	Charite University, Berlin, Germany
PAPRIKA - Patients Empowerment for Major Surgery Preparation @Home	NCT04295668	Cancer Surgical Proced...	Usual care Prehabilitation	-	Hospital Clinic of Barcelona
A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer	NCT03985267	Anxiety Stress Self Efficacy Depression Breast Cancer F... Hopefulness	Mindfulness bas...	18 Years -	University of Barcelona

Spots Global Cancer Trial Database for cognitive behavioural therapy