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

13 november 2019 bijgewerkt door: University of Wisconsin, Madison

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

38

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53705
        • University of Wisconsin Carbone Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm I (MBSR 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.
Gedragsmatig: Mindfulness-Based Stress Reduction
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
Andere namen:
  • MBSR
Geen tussenkomst: Arm II (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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in anxiety
Tijdsspanne: Baseline to up to 5 months
Measured by the 8-item anxiety subscale of the PROMIS scale.
Baseline to up to 5 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in depression
Tijdsspanne: Baseline to up to 5 months
Measured by PROMIS subscale for depression.
Baseline to up to 5 months
Change in fatigue
Tijdsspanne: Baseline to up to 5 months
Measured by PROMIS subscale for fatigue.
Baseline to up to 5 months
Change in sleep disturbance
Tijdsspanne: Baseline to up to 5 months
Measured by PROMIS subscale for sleep disturbance.
Baseline to up to 5 months
Change in sexual function
Tijdsspanne: Baseline to up to 5 months
Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
Baseline to up to 5 months
Change in existential/spiritual distress
Tijdsspanne: Baseline to up to 5 months
measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
Baseline to up to 5 months
Change in cognitive function
Tijdsspanne: Baseline to up to 5 months
Measured by the NIH Toolbox Assessments
Baseline to up to 5 months
Change in cortisol levels
Tijdsspanne: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Baseline to up to 5 months
Change in levels of pro-inflammatory cytokines
Tijdsspanne: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Baseline to up to 5 months
Change in immune cell phenotypes
Tijdsspanne: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Baseline to up to 5 months
Change in NK cell function
Tijdsspanne: Baseline to up to 5 months
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
Baseline to up to 5 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Wisconsin, Madison

Onderzoekers

  • Hoofdonderzoeker: Ryan Spencer, University of Wisconsin, Madison

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 november 2015

Primaire voltooiing (Werkelijk)

20 juni 2019

Studie voltooiing (Werkelijk)

20 juni 2019

Studieregistratiedata

Eerst ingediend

4 augustus 2015

Eerst ingediend dat voldeed aan de QC-criteria

4 augustus 2015

Eerst geplaatst (Schatting)

7 augustus 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 november 2019

Laatste update ingediend die voldeed aan QC-criteria

13 november 2019

Laatst geverifieerd

1 juli 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UW15000
  • A532820 (Andere identificatie: UW Madison)
  • 2015-0549 (Andere identificatie: Institutional Review Board)
  • SMPH\OBSTET & GYNECOL\OB-GYN (Andere identificatie: UW Madison)
  • NCI-2015-01263 (Register-ID: NCI Trial ID)

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