Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605261
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Effect of Yoga Program on Quality of Life in Women With Breast Cancer Receiving Endocrine Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Yoga Program on Quality of Life in Women With Breast Cancer Receiving Endocrine Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled trial is to evaluate the effect of a yoga program on improving the quality of life reducing joint pain and alleviating vasomotor symptoms night sweats hot flashes in women with breast cancer undergoing endocrine therapy
The main questions it aims to answer are
Does the yoga program significantly improve the quality of life in women with breast cancer undergoing endocrine therapy Is the yoga program effective in reducing joint pain in women with breast cancer Does the yoga program reduce the severity of night sweats and hot flashes in women with breast cancer Researchers will compare the intervention group which will receive the yoga program to the control group which will continue with their physician-recommended routine exercise to see if there is a difference in these outcomes
Participants will Participants will consist of women with breast cancer undergoing endocrine therapy with 64 in the yoga intervention group and 64 in the control group
Complete thePatient Assessment Form and the Functional Assessment of Cancer Therapy - Endocrine Symptoms FACT-ES scale
The intervention group will participate in a 60-minute yoga program delivered online via a digital platform four days a week for four weeks led by an instructor
The control group will not receive any intervention and will continue with their physician-recommended routine exercise
The main questions it aims to answer are
Does the yoga program significantly improve the quality of life in women with breast cancer undergoing endocrine therapy Is the yoga program effective in reducing joint pain in women with breast cancer Does the yoga program reduce the severity of night sweats and hot flashes in women with breast cancer Researchers will compare the intervention group which will receive the yoga program to the control group which will continue with their physician-recommended routine exercise to see if there is a difference in these outcomes
Participants will Participants will consist of women with breast cancer undergoing endocrine therapy with 64 in the yoga intervention group and 64 in the control group
Complete thePatient Assessment Form and the Functional Assessment of Cancer Therapy - Endocrine Symptoms FACT-ES scale
The intervention group will participate in a 60-minute yoga program delivered online via a digital platform four days a week for four weeks led by an instructor
The control group will not receive any intervention and will continue with their physician-recommended routine exercise
Detailed Description:
The goal of this randomized controlled trial is to evaluate the effect of a yoga program on improving the quality of life reducing joint pain and alleviating vasomotor symptoms such as night sweats and hot flashes in women with breast cancer undergoing endocrine therapy The participants will be divided into two groups 64 women in the yoga intervention group and 64 women in the control group
Hypotheses
H1 The yoga program will significantly improve the quality of life in women with breast cancer undergoing endocrine therapy
H1 The yoga program will be effective in reducing joint pain in women with breast cancer
H1 The yoga program will be effective in reducing the severity of night sweats and hot flashes in women with breast cancer
Population
The study population consists of women who have completed surgical treatment in oncology units have completed chemotherapy or radiation therapy and have recently started adjuvant endocrine therapy The sample size calculated using G power with an effect size of 05 a 5 error margin and 80 power includes 128 participants 64 in the intervention group and 64 in the control group taking into account possible data losses
Data Collection Tools
The research data will be collected using the Patient Identification Form and the Functional Assessment of Cancer Therapy - Endocrine Symptoms FACT-ES scale
Patient Identification Form Developed by the researcher based on literature this form consists of two sections The first section includes personal characteristics such as age gender education level and body mass index The second section investigates medical history general health information and lifestyle habits eg smoking alcohol use diet and sleep patterns
Functional Assessment of Cancer Therapy - Endocrine Symptoms FACT-ES This comprehensive scale was developed to evaluate the quality of life of cancer patients particularly those receiving endocrine therapy The scale consists of 46 items rated on a scale from 0 to 4 and it includes five main subscales Physical Well-Being SocialFamily Well-Being Emotional Well-Being Functional Well-Being Endocrine Symptom Subscale Some negatively worded items are reverse-scored and raw scores are totaled Subscale scores are calculated separately and the total score is the sum of the subscale scores Higher scores indicate better quality of life and fewer symptoms The scale can be scored manually and appropriate prorating methods are applied in the case of missing data It is valid for cancer patients aged 18 and over assessing experiences over the past seven days The assessment is conducted using a 5-point Likert scale and takes approximately 10-15 minutes It can be administered both in paper form and electronically and completed via self-reporting or interviews if necessary
Process
Participants in both the intervention and control groups will be informed about the purpose and steps of the study and the Informed Consent Form will be read and signed Written and verbal consent will be obtained from those who agree to participate in the study In the initial phase data will be collected via face-to-face interviews using the Patient Assessment Form along with weight measurement and basic movements eg standing while touching toes for 30 seconds raising arms overhead moving from standing to sitting position The FACT-ES scale will also be administered during this interview Data collection will continue using digital communication tools every two weeks once the online yoga program beginsThe intervention group will participate in a 60-minute yoga program delivered online via a digital platform four days a week for four weeks led by an instructor The control group will not receive any intervention and will continue with their physician-recommended routine exercise
Yoga Program Intervention Group
Participants in the intervention group will participate in a 60-minute yoga program delivered online via a digital platform four days a week for four weeks
Each session will begin with breathing exercises pranayama followed by yoga postures asanas and end with meditation
While the yoga program continues the Endocrine Symptoms Subscale of the FACT-ES scale will be applied in the 2nd week
Since the program is conducted online participants will be advised to perform yoga in a quiet and hygienic environment conducive to practice
Before starting the yoga practice participants will be provided with a yoga guide by the researcher
An introductory session will be held to explain the philosophy of yoga and the details of the program
Yoga mats blocks and other necessary equipment will be provided to participants before starting the practice
After each yoga session participants will be asked to provide feedback on any adverse effects they may have experienced which will be recorded through digital communication tools
One month after completing the four-week online yoga program participants will be asked how often they have continued the yoga practice at home and this will be recorded
Participants who do not continue yoga practice will be asked to provide reasons which will also be recorded
Yoga Program Structure
Warm-up 10 minutes Pranayama Breathing Exercise - 5 minutes Dirga Pranayama Three-Part Breath Slows breathing and calms the mind Gentle Neck Stretches - 5 minutes Relieves tension in the neck where stress is often stored Main Practice 45 minutes Tadasana Mountain Pose - 5 minutes An excellent starting pose for improving posture and body awareness Vrikshasana Tree Pose - 5 minutes Enhances balance and focus strengthens the legs Baddha Konasana Butterfly Pose - 5 minutes Increases flexibility in the hips and inner thighs relieves the pelvic area Marjaryasana-Bitilasana Cat-Cow Stretch - 5 minutes Stretches and revitalizes the spine alleviates back pain Paschimottanasana Seated Forward Bend - 5 minutes Stretches the back and legs reduces stress and fatigue Bhujangasana Cobra Pose - 5 minutes This chest-opening pose increases respiratory capacity and strengthens the spine
Balasana Child Pose - 5 minutes Provides deep relaxation and stress reduction Supta Matsyendrasana Reclined Twist - 5 minutes Stretches and relaxes the spine soothes the digestive system Cool-Down 10 minutes Supta Baddha Konasana Reclined Butterfly Pose - 5 minutes
Provides deep relaxation and gently stretches the inner thighs Savasana Corpse Pose - 5 minutes
Promotes deep relaxation and mental clarity
Data Analysis The data obtained from the study will be analyzed using the IBM SPSS Statistics 23 IBM SPSS Turkey software To test for the normality of the data distribution the Kolmogorov-Smirnov test will be used Values with skewness and kurtosis between 20 will be considered to have a normal distribution Descriptive statistics such as mean standard deviation percentage and frequency will be used If the data show a parametric distribution One-Way Analysis of Variance ANOVA will be used for comparisons between more than two groups and Repeated Measures ANOVA will be applied for repeated measurements To determine the differences in quality of life scores between groups an independent samples t-test will be conducted If the data do not show a normal distribution the Mann-Whitney U test will be applied In addition the Chi-Square test will be used to evaluate sociodemographic differences A significance level of p will be considered the threshold for statistical significance Finally Cohen d will be calculated to evaluate effect size
Hypotheses
H1 The yoga program will significantly improve the quality of life in women with breast cancer undergoing endocrine therapy
H1 The yoga program will be effective in reducing joint pain in women with breast cancer
H1 The yoga program will be effective in reducing the severity of night sweats and hot flashes in women with breast cancer
Population
The study population consists of women who have completed surgical treatment in oncology units have completed chemotherapy or radiation therapy and have recently started adjuvant endocrine therapy The sample size calculated using G power with an effect size of 05 a 5 error margin and 80 power includes 128 participants 64 in the intervention group and 64 in the control group taking into account possible data losses
Data Collection Tools
The research data will be collected using the Patient Identification Form and the Functional Assessment of Cancer Therapy - Endocrine Symptoms FACT-ES scale
Patient Identification Form Developed by the researcher based on literature this form consists of two sections The first section includes personal characteristics such as age gender education level and body mass index The second section investigates medical history general health information and lifestyle habits eg smoking alcohol use diet and sleep patterns
Functional Assessment of Cancer Therapy - Endocrine Symptoms FACT-ES This comprehensive scale was developed to evaluate the quality of life of cancer patients particularly those receiving endocrine therapy The scale consists of 46 items rated on a scale from 0 to 4 and it includes five main subscales Physical Well-Being SocialFamily Well-Being Emotional Well-Being Functional Well-Being Endocrine Symptom Subscale Some negatively worded items are reverse-scored and raw scores are totaled Subscale scores are calculated separately and the total score is the sum of the subscale scores Higher scores indicate better quality of life and fewer symptoms The scale can be scored manually and appropriate prorating methods are applied in the case of missing data It is valid for cancer patients aged 18 and over assessing experiences over the past seven days The assessment is conducted using a 5-point Likert scale and takes approximately 10-15 minutes It can be administered both in paper form and electronically and completed via self-reporting or interviews if necessary
Process
Participants in both the intervention and control groups will be informed about the purpose and steps of the study and the Informed Consent Form will be read and signed Written and verbal consent will be obtained from those who agree to participate in the study In the initial phase data will be collected via face-to-face interviews using the Patient Assessment Form along with weight measurement and basic movements eg standing while touching toes for 30 seconds raising arms overhead moving from standing to sitting position The FACT-ES scale will also be administered during this interview Data collection will continue using digital communication tools every two weeks once the online yoga program beginsThe intervention group will participate in a 60-minute yoga program delivered online via a digital platform four days a week for four weeks led by an instructor The control group will not receive any intervention and will continue with their physician-recommended routine exercise
Yoga Program Intervention Group
Participants in the intervention group will participate in a 60-minute yoga program delivered online via a digital platform four days a week for four weeks
Each session will begin with breathing exercises pranayama followed by yoga postures asanas and end with meditation
While the yoga program continues the Endocrine Symptoms Subscale of the FACT-ES scale will be applied in the 2nd week
Since the program is conducted online participants will be advised to perform yoga in a quiet and hygienic environment conducive to practice
Before starting the yoga practice participants will be provided with a yoga guide by the researcher
An introductory session will be held to explain the philosophy of yoga and the details of the program
Yoga mats blocks and other necessary equipment will be provided to participants before starting the practice
After each yoga session participants will be asked to provide feedback on any adverse effects they may have experienced which will be recorded through digital communication tools
One month after completing the four-week online yoga program participants will be asked how often they have continued the yoga practice at home and this will be recorded
Participants who do not continue yoga practice will be asked to provide reasons which will also be recorded
Yoga Program Structure
Warm-up 10 minutes Pranayama Breathing Exercise - 5 minutes Dirga Pranayama Three-Part Breath Slows breathing and calms the mind Gentle Neck Stretches - 5 minutes Relieves tension in the neck where stress is often stored Main Practice 45 minutes Tadasana Mountain Pose - 5 minutes An excellent starting pose for improving posture and body awareness Vrikshasana Tree Pose - 5 minutes Enhances balance and focus strengthens the legs Baddha Konasana Butterfly Pose - 5 minutes Increases flexibility in the hips and inner thighs relieves the pelvic area Marjaryasana-Bitilasana Cat-Cow Stretch - 5 minutes Stretches and revitalizes the spine alleviates back pain Paschimottanasana Seated Forward Bend - 5 minutes Stretches the back and legs reduces stress and fatigue Bhujangasana Cobra Pose - 5 minutes This chest-opening pose increases respiratory capacity and strengthens the spine
Balasana Child Pose - 5 minutes Provides deep relaxation and stress reduction Supta Matsyendrasana Reclined Twist - 5 minutes Stretches and relaxes the spine soothes the digestive system Cool-Down 10 minutes Supta Baddha Konasana Reclined Butterfly Pose - 5 minutes
Provides deep relaxation and gently stretches the inner thighs Savasana Corpse Pose - 5 minutes
Promotes deep relaxation and mental clarity
Data Analysis The data obtained from the study will be analyzed using the IBM SPSS Statistics 23 IBM SPSS Turkey software To test for the normality of the data distribution the Kolmogorov-Smirnov test will be used Values with skewness and kurtosis between 20 will be considered to have a normal distribution Descriptive statistics such as mean standard deviation percentage and frequency will be used If the data show a parametric distribution One-Way Analysis of Variance ANOVA will be used for comparisons between more than two groups and Repeated Measures ANOVA will be applied for repeated measurements To determine the differences in quality of life scores between groups an independent samples t-test will be conducted If the data do not show a normal distribution the Mann-Whitney U test will be applied In addition the Chi-Square test will be used to evaluate sociodemographic differences A significance level of p will be considered the threshold for statistical significance Finally Cohen d will be calculated to evaluate effect size
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None