Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Respiratory Aspiration

Facies

Quality of Life

Menopause

This group will be given the option to participate in a face-to-face MBM skills group intervention after conclusion of study.

This group will be given the option to participate in an Online MBM skills group intervention after conclusion of study.

Mind Body Medicine (MBM) Skills Groups provide a means for study participants to learn skills for taking care of themselves in a supportive small group setting. Participants will learn and practice a variety of specific MBM skills. These MBM skills will enable a participant to change the way she/he deals with the wide range of stressors at different stages of her/his cancer journey. Some of these MBM skills are meditation, guided imagery, biofeedback, writing, and drawing. These groups are designed to assist a participant in coming to know themselves better and in learning and using these tools that will help the participant to deal with the distress as only a small percentage of cancer patients in distress receive appropriate support.

Face-to-Face MBM Skills Group

No intervention offered during study period. Intervention is offered after completion of study.

Waitlist Control I

Waitlist Control II

Online MBM Skills Group

Werner Absenger, M.Sc.

Aim: To answer the questions of whether a Mind-Body Medicine (MBM) skills group facilitated face-to-face and online can improve measures of Quality of Life (QOL) in a population of cancer patients.

Value of Study: Technological advances have contributed to new venues for healthcare delivery. It is imperative that these new delivery methods, for individual and/or group psychosocial services are sufficiently tested and validated. Research shows that there is very little knowledge about differences in communication styles between online and face-to-face groups, nor is there much knowledge on the overall efficacy of online groups.

Phenomenon Studied: Can MBM skills groups improve the quality of life of cancer patients? Is there a difference in outcome between a MBM skills group delivered face-to-face and a MBM skills group delivered online.

Reasons Leading to Proposing the Project: Despite encouraging research showing that psychosocial interventions have positive effects in the lives of cancer patients, more research is needed due to several problems of current research, such as poor study design, lack of use of technological advances and relatively few existing studies on the effectiveness of MBM therapies in the oncological setting.

Stated Hypothesis:

Hypothesis 1:

There is no difference between baseline QOL measures and QOL measures at the end of face-to-face facilitated MBM skills groups.

Hypothesis 2:

There is no difference between baseline QOL measures and QOL measures at the end of Online facilitated MBM skills groups.

Hypothesis 3:

Participation in either, online facilitated MBM skills groups or face-to-face facilitated MBM skills groups will improve QOL measures when compared to control group.

Hypothesis 4:

Patients in the control group (waitlist control, care as usual group) will have no improvement on QOL measures.

Anticipated Value to the Larger Community: According to the National Center for Complementary and Alternative Medicine (NCCAM) "...there is a need for reliable, objective, evidence-based information regarding the usefulness and safety-or lack thereof-of CAM" (National Center for Complementary and Alternative Medicine, 2011, p.3). This study will add to general scientific knowledge of CAM and MBM.

A Pilot Study To Assess Guidance in and Subsequent Use of Mind-Body Techniques on the Quality of Life of Cancer Patients

Quality of Life Outcomes Following Mind-body Skills Training for Cancer Patients That Are Facilitated Either Face-to-face or Online: A Pilot Study

The WHOQOL-BREF is a 26-item version of the WHOQOL-100 assessment. The instrument has been tested and developed for almost 20 years and "...results indicate that overall, the WHOQOL-BREF is a sound, cross-culturally valid assessment of QOL, as reflected by its four domains: physical, psychological, social and environment" (Skevington, Lofty, \& O'Connell, 2004).

The ET5 is a five dimensional tool comprised of five visual-analogue scales in the form of four predictor domains (distress, anxiety, depression, anger) and one outcome domain (need for help). It is modeled after the original Distress Thermometer (DT) recommended by the US National Comprehensive Cancer Network. In order to detect broadly defined distress or anxiety, a combination of thermometers was most accurate (Mitchell, Baker-Glenn, Park, Granger, \& Symonds, 2010). The ET5 tool expands on the DT by combining domains in order to detect emotional complications after a diagnosis with cancer.

Absenger Cancer Education Foundation

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Chronic Pain

Pain

Neurologic Manifestations

Breast Diseases

Skin Diseases

Chronic Graft Versus Host Disease

Participants in the intervention group will receive breathing exercise training, pain information booklet, and usual care.

Participants in the control group will receive pain information booklet and usual care.

Participants will receive breathing exercise training, and a 4-week self exercise

Breathing exercise

Professor Jing-Yu (Benjamin) Tan, PhD

The study will follow the MRC Framework to develop an evidence-based BE intervention protocol to help breast cancer survivors with better management of cancer-related chronic pain.

Cancer-related chronic pain remains as a big challenge for cancer survivors, which significantly affects the quality of life of cancer survivors. Evidence suggests that pain is well managed through combination of pharmacological and non-pharmacological interventions. Among all non-pharmacological interventions, breathing exercise (BE) might have potential effect for chronic pain management in cancer survivors, but the evidence is sparse in current literature. Therefore, this study will follow the Medical Research Council Framework for Developing and Evaluating Complex intervention (the MRC Framework) to develop an evidence-based BE protocol to help with cancer-related chronic pain management in breast cancer survivors. The first two phases of the MRC Framework will be included in this study. In the first phase, an evidence-based method will be utilized to develop the BE intervention protocol. In the second phase, a pilot randomised controlled trial (RCT) will be conducted to examine the feasibility of study and the acceptability of the BE intervention by the participants as well as to preliminarily assess the effect of the BE on chronic pain management in breast cancer survivors. Semi-structured interviews will be conducted after the RCT to explore participants' experiences of participating in the study and practicing the BE.

Gender eligibility is based on the physical appearance.

Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors

An Evidence-based Breathing Exercise Intervention Protocol for Chronic Pain Management in Breast Cancer Survivors: A Preliminary Randomized Controlled Trial

It needs to get the participants' consent if the data is shared with other researchers.

The time that was taken to recruit the planned sample size of participants

The number of referrals made by clinicians in different departments divided by all referrals

Proportion of subjects who participated in the study from all subjects eligible for participation

Proportion of participants who completed the whole study divided by all subjects who enrolled in the study

The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study

Feedback from the dropout subjects to identify their reasons for dropping out

The percentage of missing values for each item of the scales used, including the Brief Pain Inventory (BPI), Quality of life Cancer Survivors Version (QOL-CSV), Functional Assessment Cancer Therapy-Breast (FACT-B), and Hospital Anxiety and Depression Scale (HADS)

the percentage of BE sessions performed by participants divided by the total number of BE sessions required

Participants' feedback on and satisfaction with the intervention using a specifically designed feedback form

Data will be collected from the participants' BE logbooks and supplemented by information collected during weekly telephone contact

Chronic pain will be measured by using the Brief Pain Inventory which measures pain intensity and pain interference with the life. For pain severity, four items are used to measure the "worst", "least", "average" and "now" with a rating scale from 0 to 10, higher number indicating the higher score in each item. For pain interference, pain is measured from 7 aspects of general activity, mood, walking, work, relations with others, sleep and enjoyment of life with a scale of 0-10, and higher score indicates severe impact of pain.

Quality of life will be measured by using the Quality of Life Cancer Survivors Version. This questionnaire contains 41 items measuring quality of life of cancer survivors from four aspects including physical well-being, psychological well-being, social well-being and spiritual well-being. The score of each item is based on a scale of 0 ( worse outcome) to 10 ( best outcome). Higher score indicates better quality of life.

Quality of life will also be measured by using the Functional Assessment of Cancer Therapy-Breast. This questionnaire has 37 items with a 5-point Likert scale ranging from 0 to 4, a higher score indicating better QoL.

Anxiety and depression will be measured by using the Hospital Anxiety and Depression Scale (HADS). This scale contains 14 items consisting of two subscales: the anxiety subscale and depression subscale with 7 items in each. The scale uses a 4-point Likert scale ranging from 0 to 3, and higher score indicates severe anxiety and depression.

The Affiliated Hospital Of Southwest Medical University

Charles Darwin University

Fatigue

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Pranayama Group Breathing Exercises Step One:Focusing on breathing (1 minute) Step Two: Alternative nasal breathing (3 minutes) Step Three: Refreshing breath (3 minutes) Step Four: Humming bee breath (2 minutes) Step Five: Focusing on breathing (1 minute)

breathing exercise

The study aims to evaluate the effectiveness of pranayama and deep breathing exercise in reducing fatigue and insomnia in patients receiving radiotherapy due to breast cancer. The randomized controlled interventional study was carried out with 60 patients divided into the pranayama (20), deep breathing exercise (20) and control group (20). Data were collected with the Piper Fatigue Scale (PFS), the Pittsburgh Sleep Quality Index (PSQI) and the Visual Analog Scale (VAS).

Study sample The study population consisted of patients diagnosed with breast cancer, who received radiotherapy in the radiation oncology unit of a hospital in Ankara, between June 01, 2017 and January 31, 2019.

At least three additional volunteers (16%) for each group were added, considering monitoring and data loss during the follow-up. Thus, the number of subjects was determined as 63 individuals (21 for each group).

Of the 63 patients, one wanted to interrupt the treatment and two did not want to continue in the study, hence the study was concluded with 20 patients in each group (60 patients).

Instruments Fatigue Visual Analog Scale (VAS) Score Piper Fatigue Scale (PFS) Insomnia Visual Analog Scale (VAS) Score Pittsburgh Sleep Quality Index (PSQI) Questionnaire on Patients' Opinions of the Exercises Patients in the pranayama, deep breathing exercise and control group were evaluated six times in terms of fatigue and insomnia VAS scores. PFS and PSQI were evaluated once prior to and after the 25-day session of radiotherapy treatment.

Interventions Protocols for pranayama and deep breathing exercises were prepared Pranayama and Deep Breathing Exercise Groups: The patients were taught pranayama and deep breathing exercises by the researcher before the radiotherapy started. The patients were observed performing these exercises for 10 minutes after each radiotherapy session (25 days) accompanied by the researcher in a quiet room within the radiotherapy unit containing two couches and a chair.

Control Group: The patients in this group did not receive any intervention.

Using Pranayama and Deep Breathing Exercises to Reduce Cancer-Related Fatigue and Insomnia During Radiotherapy

The Study Aims to Evaluate Effectiveness of Pranayama and Deep Breathing Exercise in Reducing Fatigue and Insomnia in Patients Receiving Radiotherapy Due to Breast Cancer.

This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.

The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.

Piper Fatique Scale scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.

Piper Fatique Scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.

Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study To Assess Guidance in and Subsequent Use of Mind-Body Techniques on the Quality of Life of Cancer Patients	NCT01586546	Quality of Life Life Change Eve... Neoplasms	Face-to-Face MB... Waitlist Contro... Waitlist Contro... Online MBM Skil...	18 Years -	Absenger Cancer Education Foundation
A Pilot Study To Assess Guidance in and Subsequent Use of Mind-Body Techniques on the Quality of Life of Cancer Patients	NCT01586546	Quality of Life Life Change Eve... Neoplasms	Face-to-Face MB... Waitlist Contro... Waitlist Contro... Online MBM Skil...	18 Years -	Absenger Cancer Education Foundation
A Pilot Study To Assess Guidance in and Subsequent Use of Mind-Body Techniques on the Quality of Life of Cancer Patients	NCT01586546	Quality of Life Life Change Eve... Neoplasms	Face-to-Face MB... Waitlist Contro... Waitlist Contro... Online MBM Skil...	18 Years -	Absenger Cancer Education Foundation
Breathing Exercise for Chronic Pain Management in Breast Cancer Survivors	NCT05257876	Chronic Pain Breast Neoplasm... Cancer Survivor...	Breathing exerc...	18 Years -	Charles Darwin University
Using Pranayama and Deep Breathing Exercises to Reduce Cancer-Related Fatigue and Insomnia During Radiotherapy	NCT04441827	Breast Cancer Fatigue Insomnia	breathing exerc...	18 Years -	KTO Karatay University

Spots Global Cancer Trial Database for breathing exercises