Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies

Study Overview
=================
Brief Summary
-----------------
Oncologic patients often report increased fatigue during and after chemotherapy. Evidence suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated with chemotherapy. Previous studies, mostly performed in a population of breast cancer patients, have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of life (1), reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb) (3), and reducing inflammation (4). The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and fatigue in patients with gynecological malignancies, particularly in patients with ovarian cancer.

Detailed Description
-----------------
Tai-chi/Qi-gong is a complementary medicine technique that synergizes the mind-body connection. The technique employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion. The effect of Tai-chi/Qi-gong on fatigue, quality of life, and quality of sleep will be assessed in gynecological cancer patients. This trial will recruit 60 patients with gynecological malignancies, who receive first or second line chemotherapy. The patients will be allocated according to their preference to either the study or the control group. The Tai-chi/Qi-gong classes will take place once a week, for 10 consecutive weeks, at the facilities of the gyneco-oncology department. All patients will fill out the questionnaires at the beginning of the study, after 5 weeks, and upon the completion of the study (10 weeks).

Official Title
-----------------
The Effect of Tai-chi/Qi-gong on Quality of Life (QOL), Sleep, and Fatigue in Patients With Gynecological Malignancies

Conditions
-----------------
Ovarian Cancer, Primary Peritoneal Cancer, Other Gynecological Cancers

Intervention / Treatment
-----------------
* Other: Tai-chi/Qi-gong


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with gynecological malignancies undergoing primary or secondary chemotherapy Exclusion Criteria: Motor disability; Less than 1 month since the last abdominal surgery; Ascites

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai-chi/Qi-gong<br>30 gynecological cancer patients scheduled for the first or second line of chemotherapy treatment will be recruited for this study to receive Tai-chi/qigong treatment initiated at the beginning of chemotherapy therapy, once a week (45 min each), for 10 weeks. | Other: Tai-chi/Qi-gong<br>* Tai-chi/Qi-gong employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion. The treatments will take place once a week at the Dept. of the Gyneco-oncology and the patients will be instructed to practice tai-chi at home on a daily basis<br>* Other names: Qigong;|
| No Intervention: Usual Care<br>30 gynecological cancer patients scheduled for primary or secondary chemotherapy treatment, will be evaluated by the same measures as the intervention group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA | The Multidimensional Quality of Life Scale cancer MQOLS-CA was written by Padilla (5) and translated into Hebrew by Dorit Pud (6). | Week 0, Week 5, Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Lee Fatigue Scale (LFS) | The Lee Fatigue Scale (LFS). The questionnaire was compiled by Lee (7) and translated into Hebrew by Dr. Dorit Pud (6). | Week 0, Week 5, Week 10 | 
| Change in the Visual Analog Scale for Pain |  | Week 0, Week 5, Week 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Cancer, Gynecological Malignancies, Chemotherapy, Tai-chi, Qigong, Fatigue, Quality of life, Sleep disturbance