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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Yoga Therapy; Breast Cancer; Scar Contracture; Shoulder Joint Motion

Treatments: Behavioral: Yoga therapy; Behavioral: Passive control group; Behavioral: Active control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05820373

Yoga2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 444 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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444 participants in 3 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Yoga therapy

Active control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Active control group

Passive control group

Placebo Comparator group

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.

Treatment:

Behavioral: Passive control group