Effects of Yoga on Women With Breast Cancer

Study Overview
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Brief Summary
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Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer.

Detailed Description
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Breast cancer is the most commonly diagnosed cancer worldwide, accounting for 12% of all new cancer cases annually, and there were an estimated 2.3 million new cases worldwide in 2020. Contemporary breast cancer treatments have improved therapeutic outcomes. However, these treatments cause adverse effects; for example, more than half of women with breast cancer experience treatment-related comorbidities. Over 60% of women with breast cancer have reported experiencing ipsilateral upper limb complications immediately post-treatment and these complications may become chronic or permanent disorders. Upper limb dysfunction is a long-term complication that comprises a complex range of symptoms and disorders, including lymphedema, pain, decreased joint mobility and muscle strength, sensory alterations, and neuropathies. Another prevalent and persistent problem that has been reported is sleep disturbance. According to a recent review, the prevalence of sleep disturbance ranged from 14 to 90% [pooled estimated 0.4; 95% Confidence Interval (CI) 0.29 to 0.52], and the persistence rate has been found to be more than 50%. Such side effects may lead to individual suffering and economic burdens, and can compromise the quality of life of women with breast cancer. Thus, the management of treatment-related side effects is an important part of the supportive care of women with breast cancer. Yoga is based on ancient India philosophy, and emphasizes the integration of postures, breathing, and meditation. This mind-body practice has gained popularity over the last decades and serves as a complementary approach that is commonly used for various health conditions. This safe and trendy exercise holds attractive to female target participants. Yoga combines joint movements and breathing exercises that can help the lungs to expand, resulting in the stretching of muscles and thus increasing lymphatic circulation, which improves upper limb function. Besides, Yoga combines physical activity with mindful elements consisting of breathing and meditative practices. The practice of such mindfulness with the engagement of skeletal muscles represents a holistic approach that may decrease sleep disturbance. Upper limb complications and sleep disturbances are prevalent, persistent, and serious health problems in women with breast cancer. However, these problems are underrecognized in clinical practice and thus have substantial adverse impacts on the health and quality of life of women with breast cancer. As yoga practices have been shown to improve physical and psychological health in people with cancer, such practices may also alleviate upper limb complications and sleep disturbances in women with breast cancer. However, there are few evidence-based guidelines or protocols to support the integration of yoga therapy into clinical practice for managing the health conditions of women with breast cancer. Therefore, this study aims to investigate the effects of yoga therapy on improving the upper limb functions, sleep quality, and quality of life in women with breast cancer. The research hypothesis of this study were (1) improvements in upper limb functions and sleep quality, could be observed in the experimental group across the assessment time points and (2) the experimental group should have better upper limb performance and sleep parameters than the control group immediately after Yoga intervention and also at the follow up.

Official Title
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Effects of Yoga on Physical Functioning and Sleep Quality of Women With Breast Cancer: A Pilot Randomized Controlled Trial

Conditions
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Upper Limb Functions, Sleep Quality, Upper Limb Muscle Strength, Shoulder Mobility, Heart Rate Variability, Mood, Health-related Quality of Life

Intervention / Treatment
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* Other: Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 Female Normal cognitive function Diagnosed with primary breast cancer of stage I-III Completed cancer-related treatments (including surgery, radiotherapy, and/or chemotherapy) at least 4 weeks before enrollment except conventional medical care (e.g., hormonal therapy) Exclusion Criteria: Diagnosed with distant metastasis in non-breast body part Diagnosed with significant diseases, such as cardiovascular, respiratory, neurological, musculoskeletal (except upper-extremity problems secondary to breast cancer), endocrine, metabolic, and psychological disorders Being pregnant Prior experiences of practicing yoga

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This pilot randomized controlled trial will conduct at a university-affiliated rehabilitation laboratory staring from May 2023 in Hong Kong.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga group<br>Participants will receive yoga programme over a period of eight weeks | Other: Yoga<br>* The yoga forms are designed from the modified traditional Hatha yoga style consisting of pranayama, asana, meditation with additional relaxation elements. The selected postures will engage core and upper limb muscle and which proposed to strengthen the whole body, increase flexibility of shoulder and limbs, particularly, improve upper limb mobility and functions; also, the progression of the yoga therapy is targeted to reach the variations of postures. The combined relaxation elements reinforced to achieve restoration of the body so as to improve sleep.<br>|
| No Intervention: Control group<br>The participants in the control group will receive usual care, and complete all assessments on the same timeline as the intervention group. They will be offered yoga programme at the completion of the final measurement. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb functional status, score range 0-100%, higher score means more severe disability | Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH) | T1: baseline (before the study begins). | 
| Change from baseline Upper limb functional status at 4 weeks | Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability | T2: mid-intervention (week 4) | 
| Change from baseline Upper limb functional status at 8 weeks | Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability | T3: immediately post-intervention (week 8) | 
| Change from baseline Upper limb functional status at 12 weeks | Will be assessed using the short form of the Chinese (Hong Kong) version of the Disabilities of Arm-Shoulder-Hand Questionnaire (quickDASH-HKPWH), score range 0-100%, higher score means more severe disability | T4: 1 month follow up (week 12) | 
| Sleep quality | Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep | T1: baseline (before the study begins) | 
| Change from baseline Sleep quality at 4 weeks | Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep | T2: mid-intervention (week 4) | 
| Change from baseline Sleep quality at 8 weeks | Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep | T3: immediately post intervention (week 8) | 
| Change from baseline Sleep quality at 12 weeks | Will be assessed by the Chinese (for Hong Kong) version of the Pittsburgh Sleep Quality Index questionnaire, score range 0-21, higher score means poorer sleep | T4: 1 month follow up (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb muscle strength | Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength | T1: baseline (before the study begins) | 
| Change from baseline Upper limb muscle strength at 4 weeks | Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength | T2: mid-intervention (week 4) | 
| Change from baseline Upper limb muscle strength at 8 weeks | Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength | T3: immediately post intervention (week 8) | 
| Change from baseline Upper limb muscle strength at 12 weeks | Will be determined using a handheld dynamometer, measures muscle strength in kg, higher score means better muscle strength | T4: 1 month follow up (week 12) | 
| Shoulder mobility | Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility | T1: baseline (before the study begins) | 
| Change from baseline Shoulder mobility at 4 weeks | Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility | T2: mid-intervention (week 4) | 
| Change from baseline Shoulder mobility at 8 weeks | Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility | T3: immediately post intervention (week 8) | 
| Change from baseline Shoulder mobility at 12 weeks | Will be determined by measuring the active range of motion using a goniometer, measures range of movement in degree, higher score means better shoulder flexibility | T4: 1 month follow up (week 12) | 
| Mood (including anxiety and depression symptoms) | Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression | T1: baseline (before the study begins) | 
| Change from baseline Mood (including anxiety and depression symptoms) at 4 weeks | Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression | T2: mid-intervention (week 4) | 
| Change from baseline Mood (including anxiety and depression symptoms) at 8 weeks | Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression | T3: immediately post intervention (week 8) | 
| Change from baseline Mood (including anxiety and depression symptoms) at 12 weeks | Will be assessed using The Cantonese/Chinese version of the Hospital Anxiety and Depression questionnaire, score range 0-21, higher score means more severe anxiety and depression | T4: 1 month follow up (week 12) | 
| Fatigue | Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue | T1: baseline (before the study begins) | 
| Change from baseline Fatigue at 4 weeks | Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue | T2: mid-intervention (week 4) | 
| Change from baseline Fatigue at 8 weeks | Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue | T3: mid-intervention (week 8) | 
| Change from baseline Fatigue at 12 weeks | Will be assessed using the Chinese (Cantonese) version of the Fatigue Assessment Scale questionnaire, score range 10-50, higher score means more severe fatigue | T4: 1 month follow up (week 12) | 
| Heart rate variability | Will be recorded over a 5-minute period using a validated wearable monitor | T1: baseline (before the study begins) | 
| Change from baseline Heart rate variability at 4 weeks | Will be recorded over a 5-minute period using a validated wearable monitor | T2: mid-intervention (week 4) | 
| Change from baseline Heart rate variability at 8 weeks | Will be recorded over a 5-minute period using a validated wearable monitor | T3: immediately post intervention (week 8) | 
| Change from baseline Heart rate variability at 12 weeks | Will be recorded over a 5-minute period using a validated wearable monitor | T4: 1 month follow up (week 12) | 
| Health-related quality of Life | Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life | T1: baseline (before the study begins) | 
| Change from baseline Health-related quality of Life at 4 weeks | Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life | T2: mid-intervention (week 4) | 
| Change from baseline Health-related quality of Life at 8 weeks | Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life | T3: immediately post intervention (week 8) | 
| Change from baseline Health-related quality of Life at 12 weeks | Will be assessed by the Chinese-Traditional version of the Functional Assessment of Cancer Therapy-Lymphedema questionnaire, score range 0-148, higher score means better quality of life | T4: 1 month follow up (week 12) |