This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR)
intervention works in reducing anxiety in patients who have undergone treatment for
gynecologic cancer but no longer have any sign of disease. Gynecologic cancer is cancer of
the female reproductive tract, which includes the cervix, endometrium, fallopian tubes,
ovaries, uterus, and vagina. Side effects from treatment for these cancers may include
anxiety, fatigue, depression, and sexual function changes. Mindfulness training uses
meditation and yoga to help patients focus on breathing, bodily sensations, and mental
awareness. This may help decrease patients' stress and anxiety and improve their quality of
life, and may also help their immune system.
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour
classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction
in mindfulness meditation and yoga, and gives homework assignments involving practicing the
well-being techniques taught in class. Patients are required to record and report time spent
on home practice in a journal daily, and receive a weekly reminder to report their home
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given
the option to be placed on a waitlist for the MBSR course and may complete it within 6 months
after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5
months (3 months from study completion).
- Diagnosis of any invasive gynecologic cancer without evidence of disease.
- Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was
completed within 5 years prior to date of enrollment.
- Able to speak, read and write English
- ECOG Performance Status between 0 and 3
- Subjects must have a phone.
- Experiencing 2 or more of the following symptoms felt to be associated (per the
patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety
(worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing,
memory loss), depression, existential/spiritual distress (hopelessness, lack of
meaning in life, lack of peace), fatigue, pain, and sexual dysfunction. These symptoms
may be new or worsened since cancer diagnosis. Both symptoms fomr this list must have
been present one week prior to eligibility assessment, with worst severity rating
greater than or equal to 3 (0-10 scale) for at least 1 of the 2 symptoms
- Expected to continue cancer care at UWCCC for the duration of the study.
- Undergone cancer treatment (excluding hormonal therapy or biological maintenance
therapy) in the 4 weeks prior to enrollment
- Expected to require cancer treatment, other than biologic or hormonal maintenance
therapy, during the course of the study
- Any other cancer present within the last 5 years (other than gynecologic cancer under
study and non-melanoma skin cancer)
- Practicing mindfulness meditation for an average of more than 1 hour/week or have
taken mindfulness training in the past
- Documented history of Alzheimer's disease, dementia, or other neurologic deficit that
could impact decision-making
- Prisoner or incarcerated