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The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer

Primary Purpose

Breast Cancer, Yoga Therapy, Shoulder Joint Motion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga therapy
Active control group
Passive control group
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Yoga therapy, Breast Cancer, scar contracture, shoulder joint motion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Cantonese-speaking Chinese patients were newly diagnosed with breast cancer had completed breast cancer surgery plus chemotherapy were able to give consent Exclusion Criteria: Patients who have residual breast tumors or loco-regional metastasis after treatment who were practicing yoga since the diagnosis of breast cancer or are otherwise physically unable to yoga

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Intervention group

    Active control group

    Passive control group

    Arm Description

    Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course.

    Women being allocated to the active control group will attend a 12-week, weekly, relaxation course.

    The passive control intervention will be the standard post-operative exercises which are currently introduced to women following surgery, for all women allocated to the control group.

    Outcomes

    Primary Outcome Measures

    Change in shoulder rotation flexibility
    Start by holding a strap in front of the body with both hands wide apart and palms facing downwards. Lift the strap over the head to behind the back, maintaining the hand grip on the object. This movement must be made with extended arms. Repeat the movement, moving hands closer together each time until the movement cannot be completed with straight arms. To assess the flexibility, the best score of three trials is recorded. The score is the angle of fanning out, in degrees, calculated with the formula S/2L, where S = how much the sliding handle shifted in cm during the movement; L = length of arm in cm from acromion to the metacarpophalangeal joint of the middle finger.
    Change in shoulder range of motion
    Back scratch test. This test is performed in the standing position. Place one hand behind the head and back over the shoulder, then reach as far as possible down the middle of the back, with the palm touching the body and the fingers directed downwards. Place the other arm behind the back, palm facing outward and fingers upward and reach up as far as possible attempting to touch or overlap the middle fingers of both hands. To assess the range of motion, measure the distance between the tips of the middle fingers. If the fingertips touch then the score is zero. If they do not touch, measure the distance between the finger tips (i.e. a negative score). If they overlap, measure by how much (i.e. a positive score). Take two measures and use the best score.

    Secondary Outcome Measures

    Change in generic quality of life
    The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) is used to assess health-related quality of life. The EORTC QLQ-C30 includes 30 items that measure five function scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptom items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulty. A 4-point Likert scale ranging from 0 "Not at all" to 3 "Very much" is used. All the subscales range from 0 to 100. Higher scores on the subscales of function, global health status, and symptoms indicate healthy levels of functioning, better quality of life, and higher levels of symptomatology or problems, respectively.
    Change in the severity of pain
    The severity of current pain and pain over the previous 6 months is assessed using the Chronic Pain Grade questionnaire. Patients are asked about the severity, site, and duration of their pain. All items are scored on an 11-point Likert scale, with responses ranging from 0-10. Scores are calculated for 3 subscales: the characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain; the disability score, which ranges from 0-100, is calculated as the mean rating for difficulty performing daily, social, and work activities; and the disability points score, which ranges from 0-3, is derived from a combination of ranked categories of number of disability days and disability score. Higher scores indicates higher levels of pain intensity, greater difficulty performing daily, social, and work activities, and greater disability, respectively.
    Change in psychological distress
    The 14-item Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression. Respondents will be asked to rate each of the 14 statements using a 4-point scale to indicate how they have felt in the past week. Total scores for each subscale (7 items) range from 0 to 21, with higher scores indicating greater distress. This measure has been widely used in studies of cancer patients and has demonstrated good validity and reliability.
    Change in quality of life (Breast cancer specific)
    The Standard Chinese version of the breast cancer specific module of the European Organization Research Treatment Cancer (EORTC) quality of life questionnaire (QLQ- BR23) assesses health-related quality of life. The QLQ- BR23 is a breast cancer specific measure consisted of 23 items assessing four functional domains (body image, sexual functioning, sexual enjoyment, and future perspective) and four symptom scales (arm symptoms, breast symptoms, side effects of systemic therapy, and being upset by hair loss). A 4-point Likert scale ranging from 0 "Not at all" to 3 "Very much" is used. All the subscales range from 0 to 100. Higher scores on the subscales of function and symptoms indicate healthy levels of functioning and higher levels of symptomatology or problems, respectively.
    Change in sleep quality
    The 19-item Chinese version of the Pittsburgh Sleep Quality Index (PSQI) measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction, in which each component scored from 0-3, with the global score ranging from 0-21. Higher scores indicate poorer sleep quality.
    Change in fatigue
    Fatigue is assessed using the Chalder Fatigue scale. The Chalder Fatigue scale is a 11-items scale measuring severity of physical and mental fatigue. Total fatigue score is obtained by summing all items, which are rated on a four-point Likert scale (0=not at all; 3=much more than usual). Higher scores indicate greater fatigue.

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    April 6, 2023
    Sponsor
    The University of Hong Kong
    Collaborators
    hong Kong Cancer Fund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05820373
    Brief Title
    The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer
    Official Title
    The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 14, 2013 (Actual)
    Primary Completion Date
    November 29, 2018 (Actual)
    Study Completion Date
    November 29, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong
    Collaborators
    hong Kong Cancer Fund

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present study evaluates the effect of yoga therapy on scarring contractures and shoulder joint motion and range in women diagnosed with breast cancer. A single-blinded prospective, randomized controlled trial will be used.
    Detailed Description
    To conduct a study to evaluate the effect of yoga therapy on scarring contractures and shoulder joint motion and range in women diagnosed with breast cancer using a single-blinded prospective, randomized controlled trial. The aims are to test: To evaluate the impact of yoga therapy on scarring contractures and range of motion in shoulder joints among women recovering from surgical treatment of breast cancer. To evaluate the impact of yoga therapy on health-related quality of life and symptom distress. Primary Hypotheses Intervention and control groups mean scores on measures of shoulder movement range will show no differences at baseline or significant changes at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention. Mean scores of quality of life and symptom distress between intervention and control groups at the immediate post-intervention, 3rd, 6th, and 12th month post-intervention will show no differences relative to baseline.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Yoga Therapy, Shoulder Joint Motion, Scar Contracture
    Keywords
    Yoga therapy, Breast Cancer, scar contracture, shoulder joint motion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The investigators will use a block randomization structure with randomly permuted block sizes of 2, 4 and 6 to ensure a close balance of the numbers in each arm. Randomization (by a statistician) occurs prior to eligible patients attending the clinic to minimize opportunities for selection bias.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant and inform them the allocation result. The participants are masked in terms of not knowing that the yoga therapy is hypothesized to yield larger effects than the others.
    Allocation
    Randomized
    Enrollment
    444 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course.
    Arm Title
    Active control group
    Arm Type
    Active Comparator
    Arm Description
    Women being allocated to the active control group will attend a 12-week, weekly, relaxation course.
    Arm Title
    Passive control group
    Arm Type
    Placebo Comparator
    Arm Description
    The passive control intervention will be the standard post-operative exercises which are currently introduced to women following surgery, for all women allocated to the control group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Yoga therapy
    Intervention Description
    Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course. In each yoga class, participants will be taught to perform a standardized yoga sequence including postures and breathing exercise. Each class lasts 60 minutes. A DVD demonstrating the yoga sequence will be given to each participant to prompt daily home practice.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active control group
    Intervention Description
    Women being allocated to the active control group will attend a 12-week, weekly, relaxation course. In each relaxation class, participants will be taught to learn mediation and guided relaxation, called Shavasana. Participants will be asked to lie on their back, with legs apart and their eyes closed. During the practice, participants learn how to relax the body and breath normally. Each session lasts 60 minutes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Passive control group
    Intervention Description
    The passtive control intervention will be the standard post-operative exercises which are currently introduced to women following surgery, for all women allocated to the control group. A DVD demonstrating the post-operative exercise will be given to participants to practice at home daily.
    Primary Outcome Measure Information:
    Title
    Change in shoulder rotation flexibility
    Description
    Start by holding a strap in front of the body with both hands wide apart and palms facing downwards. Lift the strap over the head to behind the back, maintaining the hand grip on the object. This movement must be made with extended arms. Repeat the movement, moving hands closer together each time until the movement cannot be completed with straight arms. To assess the flexibility, the best score of three trials is recorded. The score is the angle of fanning out, in degrees, calculated with the formula S/2L, where S = how much the sliding handle shifted in cm during the movement; L = length of arm in cm from acromion to the metacarpophalangeal joint of the middle finger.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
    Title
    Change in shoulder range of motion
    Description
    Back scratch test. This test is performed in the standing position. Place one hand behind the head and back over the shoulder, then reach as far as possible down the middle of the back, with the palm touching the body and the fingers directed downwards. Place the other arm behind the back, palm facing outward and fingers upward and reach up as far as possible attempting to touch or overlap the middle fingers of both hands. To assess the range of motion, measure the distance between the tips of the middle fingers. If the fingertips touch then the score is zero. If they do not touch, measure the distance between the finger tips (i.e. a negative score). If they overlap, measure by how much (i.e. a positive score). Take two measures and use the best score.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
    Secondary Outcome Measure Information:
    Title
    Change in generic quality of life
    Description
    The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) is used to assess health-related quality of life. The EORTC QLQ-C30 includes 30 items that measure five function scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptom items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulty. A 4-point Likert scale ranging from 0 "Not at all" to 3 "Very much" is used. All the subscales range from 0 to 100. Higher scores on the subscales of function, global health status, and symptoms indicate healthy levels of functioning, better quality of life, and higher levels of symptomatology or problems, respectively.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
    Title
    Change in the severity of pain
    Description
    The severity of current pain and pain over the previous 6 months is assessed using the Chronic Pain Grade questionnaire. Patients are asked about the severity, site, and duration of their pain. All items are scored on an 11-point Likert scale, with responses ranging from 0-10. Scores are calculated for 3 subscales: the characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain; the disability score, which ranges from 0-100, is calculated as the mean rating for difficulty performing daily, social, and work activities; and the disability points score, which ranges from 0-3, is derived from a combination of ranked categories of number of disability days and disability score. Higher scores indicates higher levels of pain intensity, greater difficulty performing daily, social, and work activities, and greater disability, respectively.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
    Title
    Change in psychological distress
    Description
    The 14-item Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression. Respondents will be asked to rate each of the 14 statements using a 4-point scale to indicate how they have felt in the past week. Total scores for each subscale (7 items) range from 0 to 21, with higher scores indicating greater distress. This measure has been widely used in studies of cancer patients and has demonstrated good validity and reliability.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
    Title
    Change in quality of life (Breast cancer specific)
    Description
    The Standard Chinese version of the breast cancer specific module of the European Organization Research Treatment Cancer (EORTC) quality of life questionnaire (QLQ- BR23) assesses health-related quality of life. The QLQ- BR23 is a breast cancer specific measure consisted of 23 items assessing four functional domains (body image, sexual functioning, sexual enjoyment, and future perspective) and four symptom scales (arm symptoms, breast symptoms, side effects of systemic therapy, and being upset by hair loss). A 4-point Likert scale ranging from 0 "Not at all" to 3 "Very much" is used. All the subscales range from 0 to 100. Higher scores on the subscales of function and symptoms indicate healthy levels of functioning and higher levels of symptomatology or problems, respectively.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
    Title
    Change in sleep quality
    Description
    The 19-item Chinese version of the Pittsburgh Sleep Quality Index (PSQI) measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction, in which each component scored from 0-3, with the global score ranging from 0-21. Higher scores indicate poorer sleep quality.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
    Title
    Change in fatigue
    Description
    Fatigue is assessed using the Chalder Fatigue scale. The Chalder Fatigue scale is a 11-items scale measuring severity of physical and mental fatigue. Total fatigue score is obtained by summing all items, which are rated on a four-point Likert scale (0=not at all; 3=much more than usual). Higher scores indicate greater fatigue.
    Time Frame
    Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Only female breast cancer patients were eligible to the present study
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cantonese-speaking Chinese patients were newly diagnosed with breast cancer had completed breast cancer surgery plus chemotherapy were able to give consent Exclusion Criteria: Patients who have residual breast tumors or loco-regional metastasis after treatment who were practicing yoga since the diagnosis of breast cancer or are otherwise physically unable to yoga
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wendy Wing Tak Lam, PhD
    Organizational Affiliation
    School of Public Health, The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All IPD that underlie results in a publication will be available from the PI upon reasonable request.
    IPD Sharing Time Frame
    Starting 6 months after publication
    IPD Sharing Access Criteria
    Information will be available from the PI upon reasonable request. The author to review requests is the PI.

    Learn more about this trial

    The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer

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