Not provided
Not provided
Not provided
Not provided
Not provided
The deparment failed to detect patients that were willing to participate in this study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai-chi/Qi-gong | Experimental | 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. |
|
| Usual Care | No Intervention | 30 gynecological cancer patients scheduled for primary or secondary chemotherapy treatment, will be evaluated by the same measures as the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai-chi/Qi-gong | Other | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the White Blood Cell Count | Results of the routine blood exams will be documented | Week 0, Week 3, Week 6, Week 9 |
| Change in the Hemoglobin in blood | Results of the routine blood exams will be documented |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dorit Gamus, M.D. Ph.D. | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Hospital | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19880433 | Background | Oh B, Butow P, Mullan B, Clarke S, Beale P, Pavlakis N, Kothe E, Lam L, Rosenthal D. Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients: a randomized controlled trial. Ann Oncol. 2010 Mar;21(3):608-614. doi: 10.1093/annonc/mdp479. Epub 2009 Oct 30. | |
| 20497921 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005221 | Fatigue |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026302 | Tai Ji |
| D064906 | Qigong |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Week 0, Week 5, Week 10 |
| Week 0, Week 3, Week 6, Week 9 |
| Change in the C-reactive protein in blood | Week 0, Week 3, Week 6, Week 9 |
| Change in the Body Weight | Week 0, Week 5, Week 10 |
| Change in the number of Emergency Room visits | Emergency Room visits for nausea, vomiting, or dehydration | Week 0, Week 5, Week 10 |
| Pattern of use of Complementary Medicine | List of Complementary modalities used including Medical Cannabis | Week 0, Week 5, Week 10 |
| Peppone LJ, Mustian KM, Janelsins MC, Palesh OG, Rosier RN, Piazza KM, Purnell JQ, Darling TV, Morrow GR. Effects of a structured weight-bearing exercise program on bone metabolism among breast cancer survivors: a feasibility trial. Clin Breast Cancer. 2010 Jun;10(3):224-9. doi: 10.3816/CBC.2010.n.030. |
| 16565626 | Background | Yeh ML, Lee TI, Chen HH, Chao TY. The influences of Chan-Chuang qi-gong therapy on complete blood cell counts in breast cancer patients treated with chemotherapy. Cancer Nurs. 2006 Mar-Apr;29(2):149-55. doi: 10.1097/00002820-200603000-00012. |
| 1301125 | Background | Padilla GV, Mishel MH, Grant MM. Uncertainty, appraisal and quality of life. Qual Life Res. 1992 Jun;1(3):155-65. doi: 10.1007/BF00635615. |
| 18082357 | Background | Pud D, Ben Ami S, Cooper BA, Aouizerat BE, Cohen D, Radiano R, Naveh P, Nikkhou-Abeles R, Hagbi V, Kachta O, Yaffe A, Miaskowski C. The symptom experience of oncology outpatients has a different impact on quality-of-life outcomes. J Pain Symptom Manage. 2008 Feb;35(2):162-70. doi: 10.1016/j.jpainsymman.2007.03.010. Epub 2007 Dec 21. |
| 2062970 | Background | Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D026741 |
| Physical Therapy Modalities |
| D001945 | Breathing Exercises |