Yoga for Psychological Distress in Gynecologic, Gastrointestinal, or Thoracic Cancer



Status:Recruiting
Conditions:Cervical Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 90
Updated:2/6/2019
Start Date:February 5, 2018
End Date:June 30, 2020
Contact:Deidre B. Pereira, PhD
Email:dpereira@ufl.edu
Phone:(352) 273-6039

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Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women With Gynecologic, Gastrointestinal, or Thoracic Cancer

This study will test the feasibility and acceptability of a yoga program for women with
gynecologic, gastrointestinal (GI), or thoracic malignancies. This study will pilot an
integrative yoga intervention that combines Western psychotherapeutic approaches with classic
yogic philosophy to reduce emotional distress among women undergoing treatment for
gynecologic, gastrointestinal (GI), or thoracic cancer and provide a comprehensive approach
to stress management across the cancer care continuum.

Gynecologic cancers are malignancies of the female reproductive tract that affect over 70,000
women per year. Treatments for gynecologic cancer often result in numerous physical and
emotional side effects that affect long-term adjustment, such as anxiety, depression, low
self-esteem, sexual dysfunction, difficulties with fertility, and surgically-induced
menopause. Even when initial treatments are successful, gynecologic cancers have a high
recurrence rate that can reach nearly 80% among those with ovarian cancer. Fear of Cancer
Recurrence (FCR) is described as one of the largest unmet psychological needs among
gynecologic cancer patients and is associated with psychological distress, increased health
care utilization, and functional impairment. Few studies have examined interventions designed
to manage symptoms of FCR, which leaves a significant gap in the literature regarding
treatment of this prominent psychosocial problem. Cancer patients report growing use of
integrative medicine therapies (e.g., yoga, acupuncture, massage) to manage unmet physical
and emotional needs related to their disease and treatment. The current study will take
advantage of this trend in supportive oncology to investigate the feasibility and
acceptability of a novel intervention program created specially to address FCR among women
with gynecologic cancer. Patients will be recruited from the UF Health/Shands Hospital
Gynecology Oncology Clinic and Medical Oncology clinic and invited to participate in a
10-week, manualized, small group yoga course. Psychoeducation modules, meditation training,
and gentle yoga poses will be integrated into a comprehensive program focused on managing the
psychosocial concerns of newly diagnosed gynecologic cancer patients. Findings from this
research will contribute to the existing literature on FCR and knowledge regarding the use of
integrative medicine techniques for addressing unmet psychological needs among gynecologic
cancer patients. If the intervention is deemed feasible and acceptable, future research may
explore ways in which this manualized yoga program compares to other psychosocial treatments
for managing FCR and other forms of emotional distress in women with cancer.

Inclusion Criteria:

- Presence of newly diagnosed

- pathology-confirmed

- (a) gynecologic cancer (e.g., cancer of the ovaries, cervix, endometrium, fallopian
tubes), any stage, or

- (b) borderline ovarian tumor, Stage II-III

- Undergoing (or have recently undergone) surgery and/or active cancer treatment (e.g.,
chemotherapy, radiation, a combination of these treatments and/or another form of
cancer treatment)

- Able to read and write in English

Exclusion Criteria:

- History of gynecologic cancer or other cancer diagnosis (excluding basal cell or
squamous cell carcinomas of the skin)

- Current, severe, uncontrolled psychopathology (e.g., symptomatic Bipolar Disorder with
a manic or depressive episode in the last six months, psychotic symptoms or disorder,
or documented personality disorder)

- History of dementia or other neurocognitive disorder that may interfere with
participants' ability to adhere to study procedures

- Poor performance status as determined by a Karnofsky Status Score < 60,

- For those with any childbearing potential (i.e., 18 - 62 years of age, have intact
reproductive organs, and/or have not yet started chemotherapy or radiation therapy):
self-reported current pregnancy, possible pregnancy, or efforts to become pregnant

- History of regular or immersive yoga practice in the last five years defined as
attending at least once weekly yoga classes for at least 6 consecutive months at any
point in the prior 5 years
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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