Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

13 novembre 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

38

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53705
        • University of Wisconsin Carbone Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Mindfulness-Based Stress Reduction
The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
Autres noms:
  • MBSR
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in anxiety
Délai: Baseline to up to 5 months
Measured by the 8-item anxiety subscale of the PROMIS scale.
Baseline to up to 5 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in depression
Délai: Baseline to up to 5 months
Measured by PROMIS subscale for depression.
Baseline to up to 5 months
Change in fatigue
Délai: Baseline to up to 5 months
Measured by PROMIS subscale for fatigue.
Baseline to up to 5 months
Change in sleep disturbance
Délai: Baseline to up to 5 months
Measured by PROMIS subscale for sleep disturbance.
Baseline to up to 5 months
Change in sexual function
Délai: 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
Délai: 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
Délai: Baseline to up to 5 months
Measured by the NIH Toolbox Assessments
Baseline to up to 5 months
Change in cortisol levels
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Wisconsin, Madison

Les enquêteurs

  • Chercheur principal: Ryan Spencer, University of Wisconsin, Madison

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 novembre 2015

Achèvement primaire (Réel)

20 juin 2019

Achèvement de l'étude (Réel)

20 juin 2019

Dates d'inscription aux études

Première soumission

4 août 2015

Première soumission répondant aux critères de contrôle qualité

4 août 2015

Première publication (Estimation)

7 août 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 novembre 2019

Dernière vérification

1 juillet 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • UW15000
  • A532820 (Autre identifiant: UW Madison)
  • 2015-0549 (Autre identifiant: Institutional Review Board)
  • SMPH\OBSTET & GYNECOL\OB-GYN (Autre identifiant: UW Madison)
  • NCI-2015-01263 (Identificateur de registre: NCI Trial ID)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner