Clinical trial NCT02518308: Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer
Official title: Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Cancer Survivor
Cognitive Impairment
Depression
Distress
Fatigue
Malignant Female Reproductive System Neoplasm
Pain
Sexual Dysfunction
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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 practice.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in anxiety
timeFrame: Baseline to up to 5 months
Secondary outcomes:
measure: Change in depression
timeFrame: Baseline to up to 5 months
measure: Change in fatigue
timeFrame: Baseline to up to 5 months
measure: Change in sleep disturbance
timeFrame: Baseline to up to 5 months
measure: Change in sexual function
timeFrame: Baseline to up to 5 months
measure: Change in existential/spiritual distress
timeFrame: Baseline to up to 5 months
measure: Change in cognitive function
timeFrame: Baseline to up to 5 months
measure: Change in cortisol levels
timeFrame: Baseline to up to 5 months
measure: Change in levels of pro-inflammatory cytokines
timeFrame: Baseline to up to 5 months
measure: Change in immune cell phenotypes
timeFrame: Baseline to up to 5 months
measure: Change in NK cell function
timeFrame: Baseline to up to 5 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan Spencer
role: PRINCIPAL_INVESTIGATOR
References: