Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Anxiety Disorders

Depressive Disorder

Brain Neoplasms

Depression

Respiratory Aspiration

Pain

Behavioral Symptoms

Heart rate variability biofeedback training administered in eight, individual, weekly, one hour sessions. There will also be 20 minutes a day of resonant frequency breathing to be conducted at home. This intervention involves teaching subjects how to breath at their resonant frequency in a relaxed, diaphramatic manner.

heart rate variability biofeedback

Wolfgang Linden, PhD

This study is designed to take a first step toward testing the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner.

More specifically, this study has been designed to test several hypothesises. Each hypothesis is based on the prediction that, in a sample of psychologically distressed PBT survivors, a course of 8 HRVB sessions will demonstrate:

* statistically significant reductions in levels of depression
* statistically significant reductions in levels of anxiety
* statistically significant increases in resting HRV
* that reductions in anxiety and depression will be significantly, negatively correlated with increases in resting HRV
* that the HRVB will be viewed as an acceptable intervention by the participants

In addition to the hypothesises stated above, the study will also investigate in a discovery oriented manner if the HRVB intervention will have positive impacts on the participants:

* levels of sleep impairment
* levels of pain

Purpose

This study will test the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner. HRVB has been shown to increase autonomic nervous system efficiency and also to decrease both anxiety and depression.

Background Rationale

Anxiety and depression are two of the strongest drivers of overall quality of life (Q of L) in survivors of primary, malignant brain tumour (PMBT). In a cohort of 73 PMBT survivors, "depression scores alone accounted for more than half of the all variance in Q of L scores" (Pelletier et al, 2003, p. 47). Anxiety symptoms were similarly negatively correlated with over-all Q of L(r = -..72) in brain tumour survivors (Janda et al., 2007). Evidence also suggests that, relative to the general population, brain tumour survivors exhibit much higher rates of both depression (Wellisch et al., 2002)and anxiety (Arnold et al., 2007).

Despite these striking findings around the prevalence and importance of anxiety and depression in the brain tumour population, not a single identified study has used a purely psychological intervention to ameliorate symptoms of depression and/or anxiety in this unique, understandably distressed population. Therefore, research of this kind is urgently needed.

Heart Rate variability Biofeedback

A course of HRVB, or some close variant of it, has shown statistically significant effects on depression and/or anxiety in numerous studies. HRVB has also recently been found to associated with improvements in pain and insomnia, two other common barriers to quality of life in PMBT survivors.

Design

Overview

As a very early stage study, a one group, open label design has been adopted.

Recruitment Process

Participants will be recruited by sending letters to potential participants identified through the BC Cancer Agency registry and by encouraging referrals from local oncologists.

Measures

The primary outcome measures will be resting HRV, the Beck Depression Inventory II, the Trait Anxiety Inventory. Secondary outcome will include the Short Form McGill Pain Questionnaire and the Pittsburgh Sleep Quality Index. Likert scale questionnaires will also be used after the intervention to assess the acceptability of the intervention.

HRVB Protocol

The protocol will involve 8 weekly sessions of up to 60 minutes each, following the general approach described by Lehrer, Vaschillo, \& Vaschillo (2000). Participants will also practice breathing at their resonant frequency for 20 minutes each day at home.

Analysis

Three forms of analysis will be conducted. First, paired t-tests of residualized changes scores and effect sizes (Cohen's d) will be used to analyze pre-post changes on all of the psychometric measures and on the HRV data. Second, correlational analysis will also be used to see if there are expected associations between pre-post changes in emotion, pain and sleep measures relative to pre-post changes in resting HRV indices. Finally, means and standard deviations will be used to assess participants' likert ratings on the acceptability of the intervention.

Plans for Current Findings

Results will be developed for publication in relevant, peer reviewed scientific journals. Results will also be used to develop future research in this line, including studying the effciacy of HRVB with psychologically distressed caregivers of PMBT survivors.

HRV Biofeedback for Brain Tumour Survivors

Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors

Widely used self report measure to assess for symptoms of depression.

The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.

Baseline level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention

Baseline level of Low Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of Low Frequency HRV power (0.04-0.15 Hz)measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention

This metric measures the standard deviation of normal beat-to-beat intervals (SDNN) that are present within the heart rythm. it is a time domain measure of HRV and it serves as a marker of overall adaptability of the nervous system.

This will be a 5 point Likert scale asking how acceptable the participants found the experience of particiapting in the intervention to be , from "not at all acceptable" to "very acceptable".

The SFMPQ is a widely used measure of pain related experience.

The Pittsburgh Sleep Quality Index (Buysse et al., 1989)is a widely used self report measure of sleep quality.

University of British Columbia

British Columbia Cancer Agency

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Self-management mobile application covering physical activity, nutrition, and breathing/relaxation

Usual care (study participation does not interfere with or change any other planned treatments)

Participants assigned to the intervention group receive access to a lifestyle mobile application for three months after inpatient rehabilitation has finished. The digital program is target group-specific and includes personalization and interactive elements without face-to-face appointments during the intervention. One virtual appointment at the beginning of the intervention (about one week post-rehabilitation) with the study staff ensures that participants familiarize themselves with the mobile application and that they are assigned to a suitable program level. The intervention is mainly based on the following behavior change technique (BCT) clusters: goals and planning, feedback and monitoring, shaping knowledge, and comparison of behavior.

Lifestyle

Anja Frei, PhD

The aim of this study is to assess the efficacy of a digital lifestyle intervention in non-small cell lung cancer (NSCLC) survivors following inpatient rehabilitation on health-related quality of life (HRQoL) over three months.

Lung cancer survivors suffer from reduced physical and psychological functioning as well as decreased overall health-related quality of life (HRQoL) due to cancer symptoms, cancer treatments, and comorbidities. Experienced symptoms by lung cancer survivors, such as cancer-related fatigue or dyspnea, persist after active treatment ends. Therefore, lung cancer survivors should receive continuous attention regarding their health and HRQoL beyond the expected cancer cure.

Physical activity, healthy nutrition, and breathing/relaxation exercises before, during, and after cancer treatments can increase physical as well as psychological functioning and HRQoL. Thus, the adhesion to an appropriate healthy lifestyle is crucial and represents an effective adjunctive strategy in the management of lung cancer survivors. Most lung cancer survivors, however, are sedentary and fail to meet official lifestyle recommendations, for instance, of the American Cancer Society or the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR).

The present project evaluates a mobile application for non-small cell lung cancer (NSCLC) survivors that will be used for three months after inpatient rehabilitation has finished. The main foci of the mobile application are physical activity, nutrition, and breathing/relaxation. The contents of the mobile application and the mobile application itself were developed in an iterative co-creation process involving software developers and potential users as well as researchers and clinicians from different disciplines (e.g., physical therapy and nutritional therapy).

Digital Lifestyle Intervention for Lung Cancer Survivors After Inpatient Rehabilitation

Effect of a Digital Lifestyle Intervention on Health-Related Quality of Life in Non-Small Cell Lung Cancer Survivors After Inpatient Rehabilitation (QUALUCA): a Multicenter Randomized Controlled Trial

Pseudonymized data will be made available upon reasonable request after the main results have been published. The privacy of each subject and confidentiality of their information will be preserved in reports and publication of data.

mHealth App Usability Questionnaire (MAUQ)

Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) (4-item measures of implementation outcomes)

Short semi-structured interview; outcomes will be qualitatively assessed (no scale is used)

Cancer treatments (e.g., chemotherapy) and therapies/support (e.g., physical therapy, self-help group) participants might have received during the last 3 months (2 items)

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (2 items; 7-point Likert-type scale; the score ranges from 0 to 100; a high score for the global health status represents a high HRQoL)

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (28 items; 4-point Likert-type scale; 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 3 symptom scales (fatigue, nausea and vomiting, pain), 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties); all scales and single-item measures range in score from 0 to 100)

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 29 (lung cancer-specific module) (EORTC QLQ-LC29) (29 items; 4-point Likert-type scale / 5 multi-item scales and 5 single items; all scales and single-item measures range in score from 0 to 100)

Computed using self-reported body weight \[kg\] and height \[m\]

Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) (physical activity before inpatient rehabilitation and physical activity over the last week)

1-Minute Sit-to-Stand Test (number of repetitions)

Simplified Nutritional Appetite Questionnaire (SNAQ) (4 items; 5-point Likert-type scale)

Short form of the Patient Health Questionnaire (PHQ-4) (4 items)

Shortened version of the Patient Enablement Scale-13 (PEN-13) (5 out of 13 items; 5-point Likert-type scale)

EuroQol Group Visual Analogue Scale (EQ VAS) (vertical visual analog scale that takes values between 100 \[best imaginable health\] and 0 \[worst imaginable health\], on which respondents provide a global assessment of their health)

Kai-Uwe Schmitt, PhD, MEng, ICID

Sponsor

Skin and Connective Tissue Diseases

Breast Neoplasms

Fatigue

Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle.

Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy

1-hour long yoga breathing classes, taught once per week for 2-8 consecutive weeks. Dose (Number of classes) administered is dependent on randomization arm and individuals' chemotherapy cycle length.

Pranayama (Yoga Breathing) Techniques

The purpose of this study is to determine the feasibility and efficacy of yoga breathing techniques to manage fatigue and other cancer-related side effects, in cancer patients undergoing chemotherapy.

Fatigue is the most common complaint among cancer patients. This pilot study will evaluate the effects of pranayama (ancient yoga breathing techniques) on fatigue and quality of life among 30 patients undergoing chemotherapy, on an every 2, 3, or 4 week schedule, with a fatigue score of at least 4 on a scale of 0 (none) to 10 (most). Patients will be randomized to either pranayama or wait-list control. The pranayama group will learn and practice 3 breathing techniques on a daily basis. The study period will occur during 2 consecutive cycles of chemotherapy (cycle A and Cycle B), and the wait-list control patients will crossover to the treatment arm at the beginning of his/her Cycle B. Fatigue will be measured using the revised Piper Fatigue Scale along with quality of life measures. These study measures will be conducted at baseline, at the end of cycle A, and at the end of cycle B. We hypothesize that pranayama will improve clinical symptoms of fatigue and quality of life among patients undergoing chemotherapy.

Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy

Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy

Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures

fatigue, sleep, stress, anxiety and depression quality of life

University of California, San Francisco

Assistant Clinical Professor

A total of up to 12 scanning sessions used to understand how the tumor and other organs move while breathing.

Motion CT Scans

James D. Cox, MD

Primary Objectives:

* To collect accurate and reliable respiration-induced anatomic structure motion data using four-dimensional (4-D) imaging technology.
* To analyze these data to study respiration-induced variations and patterns in variations of positions, shapes and volumes of tumors and normal anatomic structures in the thorax and abdomen over a breathing cycle, from one breathing cycle to the next, day-to-day and over the course of radiotherapy.
* To assess dosimetric and potential clinical consequences of respiratory motion in the current practice of radiotherapy through preclinical treatment simulation (treatment planning) studies.
* To quantify the potential consequences of explicitly accounting for respiration-induced motion on dose distributions and outcome (tumor control probabilities and normal tissue complication probabilities) through preclinical treatment simulation studies.

Secondary Objectives:

* To investigate the feasibility of using patient training to regulate patient breathing and improve the quality of images and to stratify patients for their eligibility for respiratory-correlated imaging and radiotherapy and for the implementation of various strategies for mitigation of respiratory-induced motion.
* To assess the degree of correlation of the marker (or internal anatomic structure such as diaphragm) being tracked as surrogate of breathing with the motion of structures and the intra-fraction and inter-fraction reproducibility of such correlation.
* To quantify the effects of radiation therapy on the patterns of respiratory-induced motion of structures through preclinical treatment simulation studies.
* To compare various strategies for either accounting for or mitigating respiration-induced motion in the planning and delivery of radiation therapy.

You will be taking part in this study while you receive radiotherapy treatment for your tumor.

You will be trained to breathe in a certain way that will help the study staff to perform motion CT scans. You may be asked to breathe normally, or hold your breath, or breathe while following a TV monitor. On the monitor, you will be viewing your breathing trace and using the trace to regulate your breathing as instructed by the health professionals.

While you are in the right position for the scan, the study staff will perform motion CT scans. A total of up to 12 scanning sessions will be held over your entire course of radiotherapy. The first scanning session may last from 45 to 90 minutes, but later sessions may be shorter. These CT scans are separate from the routine CT scans you may receive as part of regular radiation treatment planning.

Scans may be taken at various periods of time. The scans can be taken one right after another, or with a short separation between them. One scan can be taken on the first day, and the next scan on the next day, or up to a week later.

By looking at the scans, researchers can better understand how your tumor and other organs move from breath to breath, from day to day, and from week to week.

This is an investigational study. About 210 patients with the same tumor location as you will take part in this study. All will be enrolled at M. D. Anderson.

Respiratory Tumor and Normal Tissue Motion

Assessing the Magnitude and Potential Impact of Respiration-Induced Three-Dimensional Motion of Tumors and Normal Tissues Using Four-Dimensional CT Technology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HRV Biofeedback for Brain Tumour Survivors	NCT01772498	Depression Anxiety Sleep Impairmen...	heart rate vari...	19 Years -	British Columbia Cancer Agency
Digital Lifestyle Intervention for Lung Cancer Survivors After Inpatient Rehabilitation	NCT05819346	Non-Small Cell ...	Lifestyle	18 Years -	Bern University of Applied Sciences
Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy	NCT00982748	Breast Cancer	Pranayama (Yoga...	18 Years -	University of California, San Francisco
HRV Biofeedback for Brain Tumour Survivors	NCT01772498	Depression Anxiety Sleep Impairmen...	heart rate vari...	19 Years -	British Columbia Cancer Agency
Respiratory Tumor and Normal Tissue Motion	NCT00415675	Lung Cancer Abdominal Cance...	Motion CT Scans	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for breathing

Every month we try and update this database with for breathing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for breathing

Every month we try and update this database with for breathing cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for breathing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.