Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies
Primary Purpose
Ovarian Cancer, Primary Peritoneal Cancer, Other Gynecological Cancers
Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Tai-chi/Qi-gong
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, Gynecological Malignancies, Chemotherapy, Tai-chi, Qigong, Fatigue, Quality of life, Sleep disturbance
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
Sites / Locations
- Sheba Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tai-chi/Qi-gong
Usual Care
Arm Description
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.
30 gynecological cancer patients scheduled for primary or secondary chemotherapy treatment, will be evaluated by the same measures as the intervention group.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Change in the Visual Analog Scale for Pain
Full Information
NCT ID
NCT01880996
First Posted
May 30, 2013
Last Updated
June 10, 2015
Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT01880996
Brief Title
Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies
Official Title
The Effect of Tai-chi/Qi-gong on Quality of Life (QOL), Sleep, and Fatigue in Patients With Gynecological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The deparment failed to detect patients that were willing to participate in this study
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cancer, Other Gynecological Cancers
Keywords
Ovarian Cancer, Gynecological Malignancies, Chemotherapy, Tai-chi, Qigong, Fatigue, Quality of life, Sleep disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai-chi/Qi-gong
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
30 gynecological cancer patients scheduled for primary or secondary chemotherapy treatment, will be evaluated by the same measures as the intervention group.
Intervention Type
Other
Intervention Name(s)
Tai-chi/Qi-gong
Other Intervention Name(s)
Tai Chi, Qi-gong, Taichi, Qigong
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA
Description
The Multidimensional Quality of Life Scale cancer MQOLS-CA was written by Padilla (5) and translated into Hebrew by Dorit Pud (6).
Time Frame
Week 0, Week 5, Week 10
Secondary Outcome Measure Information:
Title
Change in the Lee Fatigue Scale (LFS)
Description
The Lee Fatigue Scale (LFS). The questionnaire was compiled by Lee (7) and translated into Hebrew by Dr. Dorit Pud (6).
Time Frame
Week 0, Week 5, Week 10
Title
Change in the Visual Analog Scale for Pain
Time Frame
Week 0, Week 5, Week 10
Other Pre-specified Outcome Measures:
Title
Change in the White Blood Cell Count
Description
Results of the routine blood exams will be documented
Time Frame
Week 0, Week 3, Week 6, Week 9
Title
Change in the Hemoglobin in blood
Description
Results of the routine blood exams will be documented
Time Frame
Week 0, Week 3, Week 6, Week 9
Title
Change in the C-reactive protein in blood
Time Frame
Week 0, Week 3, Week 6, Week 9
Title
Change in the Body Weight
Time Frame
Week 0, Week 5, Week 10
Title
Change in the number of Emergency Room visits
Description
Emergency Room visits for nausea, vomiting, or dehydration
Time Frame
Week 0, Week 5, Week 10
Title
Pattern of use of Complementary Medicine
Description
List of Complementary modalities used including Medical Cannabis
Time Frame
Week 0, Week 5, Week 10
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorit Gamus, M.D. Ph.D.
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Hospital
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
19880433
Citation
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.
Results Reference
background
PubMed Identifier
20497921
Citation
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.
Results Reference
background
PubMed Identifier
16565626
Citation
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.
Results Reference
background
PubMed Identifier
1301125
Citation
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.
Results Reference
background
PubMed Identifier
18082357
Citation
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.
Results Reference
background
PubMed Identifier
2062970
Citation
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.
Results Reference
background
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Tai-chi / Qi-gong in Patients With Patients With Gynecological Malignancies
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