Effect of Yoga Program on Quality of Life in Women With Breast Cancer Receiving Endocrine Therapy

NCT06605261 | Not Yet Recruiting

• 1 other identifier: 2024-10/453
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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 the;Patient 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.

Conditions

Breast Cancer; Yoga; Quality of Life; Nursing; Endocrine Therapy

Keywords

breast cancer; yoga; quality of life; nursing; endocrine therapy

Outcome Measures

Primary Outcomes (2)

• Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

  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 primary subscales: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Endocrine Symptom Subscale. 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. It is valid for cancer patients aged 18 and over, assessing experiences over the past seven days. The assessment uses a 5-point Likert scale and takes approximately 10-15 minutes.

  1 week before the participants start the Yoga program.

• Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

  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 primary subscales: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Endocrine Symptom Subscale. 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. It is valid for cancer patients aged 18 and over, assessing experiences over the past seven days. The assessment uses a 5-point Likert scale and takes approximately 10-15 minutes.

  through study completion, average of one year

Study Arms (2)

Yoga (intervention) Group

EXPERIMENTAL

A yoga program will be conducted with 64 women undergoing endocrine therapy, experiencing joint pain or vasomotor symptoms, who are randomly assigned to the intervention group. The program will be delivered online via a digital platform for 4 weeks, 60 minutes per session, 4 days a week, with an instructor. An introductory session will provide information on yoga philosophy and program details. Each session will start with breathing exercises (pranayama), followed by yoga postures (asanas), and end with meditation. Participants will receive a yoga guide and necessary equipment (yoga mats, blocks) before starting. The FACT-ES Endocrine Symptoms Subscale will be re-administered in the second week. After each session, participants will report any adverse effects via digital communication. One month after the program, participants will be asked if they continued yoga at home, and reasons for discontinuation will be recorded.

Other: Yoga (intervention) group

Control Group

NO INTERVENTION

No intervention will be applied to individuals in this group, and they will continue with the routine exercises recommended by their physicians. After their data is collected as part of the control group, they will be invited by the researcher to participate in the online yoga sessions conducted with the intervention group.

Interventions

Yoga (intervention) group OTHER

The yoga (intervention) group comprises 64 women with breast cancer who have been randomly assigned and are undergoing endocrine therapy. To alleviate arthralgia and vasomotor symptoms (hot flashes, night sweats), a structured yoga program will be administered during the initial months of endocrine therapy, consisting of 60-minute sessions, 4 days per week, for a duration of one month.

Yoga (intervention) Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years of age,
• Having the ability to read, write, and speak Turkish,
• Having a diagnosis of breast cancer,
• Having completed surgical treatment,
• Having completed chemotherapy or radiation therapy,
• Recently starting endocrine therapy,
• Having a Body Mass Index (BMI) below 35.

You may not qualify if:

• Being over 70 years of age,
• Having a diagnosis of metastatic disease,
• Previous participation in yoga or similar exercises,
• Having a physical disability that prevents practicing yoga,
• Having a condition that causes shortness of breath (e.g., COPD),
• Having another chronic heart or lung disease that prevents yoga practice,
• Having a serious psychiatric illness or cognitive impairment.

Sponsors & Collaborators

• Gözde Gür: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga; Methods; Population Groups

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; Investigative Techniques; Demography; Population Characteristics

Study Officials

• Gözde Gür, MSc

  İstanbul University Cerrahpaşa

  PRINCIPAL INVESTIGATOR

• Aysun Ardıç, Assoc Prof

  İstanbul University Cerrahpaşa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gözde Gür

CONTACT

543 595 4116; gozde.gur@ogr.iuc.edu.tr

Aysun Ardıç, Assoc Prof

CONTACT

533 643 4730; aysun.ardic@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 20, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 23, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share