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Protocol No. UW15000

Principal Investigator Spencer, Ryan

Phase N/A (Cancer Control)

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates

Objective The purpose of the research is to find out if a well-being intervention, called Mindfulness-Based Stress Reduction (MBSR), can improve the quality of life (QOL) of gynecologic cancer survivors.

Treatment Patients will be randomly assigned (like flipping a coin) to one of two groups. You have an equal chance of being placed into either of the groups. The two groups are: Mindfulness-Based Stress Reduction (MBSR) and Wait list Control.

Description If you are assigned to the MBSR group, you will attend an 8-week course that meets once a week for 2.5 hours and requires daily homework. The course will also include one 6 hour class, which will occur on a Saturday approximately 6-7 weeks after the class begins. About a week prior to the course, there is also an introductory session, which lasts about an hour. The MBSR program involves instruction in mindfulness meditation and yoga. Classes may be audio recorded to ensure consistency of instruction. Homework will involve practicing the well-being techniques taught in class. You will be required to record and report time spent engaged in home practice on a daily basis. The MBSR course is conducted by the UW Health Integrative Medicine Mindfulness Program. The course takes place at designated UW Health locations. If you are assigned to the wait list control group, you will not participate in a class during the study, however you will have the option to receive an MBSR class free of charge after your study participation is complete. In addition to the 8 week MBSR course (for subjects randomized to receive it), you will have up to 4 study visits, lasting 1-2 hours each. These visits will take place in the UW Gyn-Oncology Clinic Click here for more info.

Key Eligibility
  • 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
  • 18 years of age or older
  • Subjects must have a phone
  • Experiencing 2 or more of the following symptoms: 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
  • Expected to continue cancer care at UWCCC for the duration of the study
  • Patients will be excluded if they have undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
  • Patients will be excluded if they are expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
  • Patients will be excluded if they have practiced mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past

Applicable Disease Sites Cervix; Ovary; Uterus

Therapies Involved Not Applicable; Symptom/Supportive Care

Status Open

Participating Institutions UW Hospital and Clinics