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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cancer, Other Gynecological Cancers

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA

Outcome Description:

The Multidimensional Quality of Life Scale cancer MQOLS-CA was written by Padilla (5) and translated into Hebrew by Dorit Pud (6).

Outcome Time Frame:

Week 0, Week 5, Week 10

Safety Issue:

No

Principal Investigator

Dorit Gamus, M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sheba Medical Center

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

SHEBA-13-0112-DG-CTIL

NCT ID:

NCT01880996

Start Date:

June 2013

Completion Date:

June 2015

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Other Gynecological Cancers
  • Ovarian Cancer
  • Gynecological Malignancies
  • Chemotherapy
  • Tai-chi
  • Qigong
  • Fatigue
  • Quality of life
  • Sleep disturbance
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

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