NCT05820373 — The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer · CancerIndex

Clinical trial · Interventional

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

The Effect of Yoga Therapy on Post-operative Side-effects Among Women With Breast Cancer: a Randomized Controlled Trial

NCT05820373CI-TRIAL-00065789completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Scar Contracture	—	UNRESOLVED	—
Shoulder Joint Motion	—	UNRESOLVED	—
Yoga Therapy	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Active control group	Behavioral	—	UNRESOLVED
Passive control group	Behavioral	—	UNRESOLVED
Yoga therapy	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Intervention group
description
Women being allocated to the intervention group will attend a 12-week, bi-weekly, specially designed yoga therapy course.
interventionNames
1. Behavioral: Yoga therapy
type
ACTIVE_COMPARATOR
label
Active control group
description
Women being allocated to the active control group will attend a 12-week, weekly, relaxation course.
interventionNames
1. Behavioral: Active control group
type
PLACEBO_COMPARATOR
label
Passive control group
description

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Primary outcomes (2)

measure
Change in shoulder rotation flexibility
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.
measure
Change in shoulder range of motion
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.

Secondary outcomes (6)

measure
Change in generic quality of life
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.
measure
Change in the severity of pain
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.
measure
Change in psychological distress
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.
measure
Change in quality of life (Breast cancer specific)
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.
measure
Change in sleep quality
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.
measure
Change in fatigue
timeFrame
Baseline, immediate post-intervention, 3rd, 6th, and 12th month post-intervention.
description
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.