Breast CancerNCT05820373
The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer
A study testing Yoga therapy in people with Breast Cancer and Yoga Therapy, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Yoga Therapy, Shoulder Joint Motion
- What is being tested?
- Yoga therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2013to 29 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cantonese-speaking Chinese patients
- were newly diagnosed with breast cancer
- had completed breast cancer surgery plus chemotherapy
- were able to give consent
Who cannot join
- 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
About this study
Official title: The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Breast Cancer, Yoga Therapy, Shoulder Joint Motion, Scar Contracture
- Being tested
- Yoga therapy, Active control group, Passive control group
- Keywords
- Yoga therapy, Breast Cancer, scar contracture, shoulder joint motion
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga therapyBehavioural
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.
Active control groupBehavioural
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.
Passive control groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course. Receives: Behavioral: Yoga therapy |
| Active control group | Active comparator | Women being allocated to the active control group will attend a 12-week, weekly, relaxation course. Receives: Behavioral: Active control group |
| Passive control group | Placebo comparator | 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. Receives: Behavioral: Passive control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Secondary outcomes (6)
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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.
Measured: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start14 May 2013
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- hong Kong Cancer Fund
- Responsible party
- Principal investigator, Wendy Wing Tak Lam, The University of Hong Kong
- Investigators
- Wendy Wing Tak Lam, PhD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820373
- Sponsor's protocol ID
- Yoga2013
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05820373
- Acronym / sponsor ID
- Yoga2013
- Conditions
- Breast Cancer, Yoga Therapy, Shoulder Joint Motion, Scar Contracture
- Keywords
- Yoga therapy, Breast Cancer, scar contracture, shoulder joint motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- hong Kong Cancer Fund
- Study start
- 14 May 2013 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Yoga therapyWomen being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course. |
| Active control group | Active comparator | Behavioral: Active control groupWomen being allocated to the active control group will attend a 12-week, weekly, relaxation course. |
| Passive control group | Placebo comparator | Behavioral: Passive control groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cantonese-speaking Chinese patients
- were newly diagnosed with breast cancer
- had completed breast cancer surgery plus chemotherapy
- were able to give consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga therapyWomen 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. | Behavioural | Intervention group |
| Active control groupWomen 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. | Behavioural | Active control group |
| Passive control groupThe 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. | Behavioural | Passive control group |
Primary outcome
Change in shoulder rotation flexibility
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
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.
6 secondary outcomes
Change in generic quality of life
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Change in the severity of pain
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Change in psychological distress
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Change in quality of life (Breast cancer specific)
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Change in sleep quality
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Change in fatigue
Time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available from the PI upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Wing Tak Lam, PhD principal investigator
School of Public Health, The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Yoga therapy in people with Breast Cancer and Yoga Therapy, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in shoulder rotation flexibility (time frame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.