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

NCT05820373 | Completed

• 1 other identifier: Yoga2013
• Study Type: interventional
• Target: 444
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Yoga therapy; Breast Cancer; scar contracture; shoulder joint motion

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.

Secondary Outcomes (6)

• Change in generic quality of life

  Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.

• Change in the severity of pain

  Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.

• Change in psychological distress

  Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.

• Change in quality of life (Breast cancer specific)

  Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.

• Change in sleep quality

  Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.

Study Arms (3)

Intervention group

EXPERIMENTAL

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

Behavioral: Yoga therapy

Active control group

ACTIVE COMPARATOR

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

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.

Behavioral: Passive control group

Interventions

Yoga therapy 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.

Intervention group

Active control group 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.

Active control group

Passive control group 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.

Passive control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female breast cancer patients were eligible to the present study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cantonese-speaking Chinese patients
• were newly diagnosed with breast cancer
• had completed breast cancer surgery plus chemotherapy
• were able to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• hong Kong Cancer Fund: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Wendy Wing Tak Lam, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 19, 2023
• Study Start: May 14, 2013
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.