Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer

Completed · Not applicable

Conditions studied: Anxiety, Cancer Survivor, Cognitive Impairment, Depression, Distress, Fatigue, Malignant Female Reproductive System Neoplasm, Pain, Sexual Dysfunction

In brief

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.

Key facts

Study ID

NCT02518308

Run by

University of Wisconsin, Madison

People needed

38

Starts

2015-11-18

Expected to finish

2019-06-20

Last updated by the study team

2019-11-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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