Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer
13. november 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
38
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Wisconsin
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Madison, Wisconsin, Forente stater, 53705
- University of Wisconsin Carbone Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
Andre navn:
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Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in anxiety
Tidsramme: Baseline to up to 5 months
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Measured by the 8-item anxiety subscale of the PROMIS scale.
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Baseline to up to 5 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in depression
Tidsramme: Baseline to up to 5 months
|
Measured by PROMIS subscale for depression.
|
Baseline to up to 5 months
|
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Change in fatigue
Tidsramme: Baseline to up to 5 months
|
Measured by PROMIS subscale for fatigue.
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Baseline to up to 5 months
|
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Change in sleep disturbance
Tidsramme: Baseline to up to 5 months
|
Measured by PROMIS subscale for sleep disturbance.
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Baseline to up to 5 months
|
|
Change in sexual function
Tidsramme: Baseline to up to 5 months
|
Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
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Baseline to up to 5 months
|
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Change in existential/spiritual distress
Tidsramme: Baseline to up to 5 months
|
measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
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Baseline to up to 5 months
|
|
Change in cognitive function
Tidsramme: Baseline to up to 5 months
|
Measured by the NIH Toolbox Assessments
|
Baseline to up to 5 months
|
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Change in cortisol levels
Tidsramme: 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
|
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Change in levels of pro-inflammatory cytokines
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ryan Spencer, University of Wisconsin, Madison
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. november 2015
Primær fullføring (Faktiske)
20. juni 2019
Studiet fullført (Faktiske)
20. juni 2019
Datoer for studieregistrering
Først innsendt
4. august 2015
Først innsendt som oppfylte QC-kriteriene
4. august 2015
Først lagt ut (Anslag)
7. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. november 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UW15000
- A532820 (Annen identifikator: UW Madison)
- 2015-0549 (Annen identifikator: Institutional Review Board)
- SMPH\OBSTET & GYNECOL\OB-GYN (Annen identifikator: UW Madison)
- NCI-2015-01263 (Registeridentifikator: NCI Trial ID)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .