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Mind-Body Intervention in Glioma Couples

Aktiv, nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT03244995 ist eine interventionsstudie zur Untersuchung von Glioblastom, Niedriggradiges Gliom, Bösartiges Gliom, Metastasierte bösartige Neubildung im Gehirn, Partner, WHO-Grad-III-Gliom und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 6. August 2017 und soll 74 Teilnehmer aufnehmen. Durchgeführt von MD Anderson Krebszentrum ist der Abschluss für 31. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 13. August 2025 aktualisiert.
Kurzbeschreibung
This trial studies how well a couple-based mind body program works in improving spiritual, psychosocial, and physical quality of life in patients with high or low grade glioma or tumors that have spread to the brain and their partners. A couple-based mind body program may help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life in patients with glioma or tumors that have spread to the brain and their partners.
Ausführliche Beschreibung
PRIMARY OBJECTIVES:

I. Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high grade glioma (HGG) and their partners.

II. Establish the initial efficacy of the CBMB program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary) outcomes relative to a waitlist control (WLC) group.

EXPLORATORY OBJECTIVES:

I. Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (CBMB PROGRAM): Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.

GROUP II (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.

After completion of study, patients are followed up at 3 months.

Offizieller Titel

An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners

Erkrankungen
GlioblastomNiedriggradiges GliomBösartiges GliomMetastasierte bösartige Neubildung im GehirnPartnerWHO-Grad-III-Gliom
Weitere Studien-IDs
NCT-Nummer
NCT03244995
Studienbeginn (tatsächlich)
2017-08-06
Zuletzt aktualisiert
2025-08-13
Studienende (vorauss.)
2025-12-31
Geplante Rekrutierung
74
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Supportivtherapie
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellGroup I (CBMB program)
Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.
Mind-body Intervention Procedure
Undergo CBMB program
Lebensqualitätsbewertung
Ancillary studies
Fragebogenverwaltung
Ancillary studies
Aktives VergleichspräparatGroup II (waitlist control)
Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
Lebensqualitätsbewertung
Ancillary studies
Fragebogenverwaltung
Ancillary studies
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
Up to 6 weeks
Feasibility of CBMB program as determined by attrition
Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable.
Up to 6 weeks
Feasibility of CBMB program as determined by adherence
Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.
Up to 6 weeks
Feasibility of CBMB program as determined by acceptability
Trial considered feasible if \> 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable.
Up to 6 weeks
CBMB program efficacy
Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance.
Up to 6 weeks
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • PATIENT ONLY: Patients with a diagnosis of HGG or low grade glioma (LGG), based on radiographic or pathologic diagnosis of grade III or IV listed in the medical records, or patients with a malignancy that has metastasized to the brain
  • PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)
  • PATIENT ONLY: Karnofsky performance status (KPS) of 80 or above
  • PATIENT ONLY: Having a spouse/romantic partner (including same-sex) and who is willing to participate
  • PATIENT & PARTNER: Able to read and speak English
  • PATIENT & PARTNER: Able to provide informed consent
  • PATIENT & PARTNER: Have access to internet connectivity

  • PATIENT ONLY: Regularly (self-defined) participation in psychotherapy or a formal cancer support group
  • PATIENT ONLY: Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
M.D. Anderson Cancer Center logoMD Anderson Krebszentrum1128 aktive klinische Studien zum Erkunden
National Cancer Institute (NCI) logoNationales Krebsinstitut, USA3028 aktive klinische Studien zum Erkunden
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1 Studienstandorte in 1 Ländern

Texas

M D Anderson Cancer Center, Houston, Texas, 77030, United States