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

NCT ID: NCT05820373

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-14

Study Completion Date

2018-11-29

Brief Summary

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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

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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.

Conditions

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Breast Cancer Yoga Therapy Shoulder Joint Motion Scar Contracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Yoga therapy

Intervention Type BEHAVIORAL

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 group

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

Group Type ACTIVE_COMPARATOR

Active control group

Intervention Type BEHAVIORAL

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 group

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.

Group Type PLACEBO_COMPARATOR

Passive control group

Intervention Type BEHAVIORAL

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.

Interventions

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Yoga therapy

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

Active control group

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

Passive control group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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hong Kong Cancer Fund

UNKNOWN

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Wendy Wing Tak Lam

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy Wing Tak Lam, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, The University of Hong Kong

Other Identifiers

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Yoga2013

Identifier Type: -

Identifier Source: org_study_id

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