Clinical trial NCT05820373: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Yoga Therapy
Shoulder Joint Motion
Scar Contracture
Keywords: Yoga therapy
Breast Cancer
scar contracture
shoulder joint motion
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: hong Kong Cancer Fund
First posted: 2023-04-19
Enrollment: 444
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

1. 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.
2. To evaluate the impact of yoga therapy on health-related quality of life and symptom distress.

Primary Hypotheses

1. 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.
2. 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.

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

Primary outcomes:
measure: Change in shoulder rotation flexibility
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
measure: Change in shoulder range of motion
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Secondary outcomes:
measure: Change in generic quality of life
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
measure: Change in the severity of pain
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
measure: Change in psychological distress
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
measure: Change in quality of life (Breast cancer specific)
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
measure: Change in sleep quality
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
measure: Change in fatigue
timeFrame: Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
Other outcomes:
Locations:
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Wing Tak Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: