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Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being (LWBC)

2. juni 2026 opdateret af: University of Colorado, Denver

Pilot Study of the Living Well With Brain Cancer Intervention

The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:

  • Is it feasible to conduct this program?
  • Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Anschutz
        • Kontakt:
        • Ledende efterforsker:
          • Bethany M Kwan, PhD, MSPH
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Cleveland Medical Center
        • Ledende efterforsker:
          • Molly McVoy, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Currently living in the United States
  • Aged 18 years or older
  • Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)
  • Treating prescribing provider who follows regularly with participant

Exclusion Criteria:

  • <1 month since initial diagnosis and/or <1 month since surgical resection
  • Enrollment in hospice
  • Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed
  • Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)
  • Not able to communicate in English at a conversational level

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group Self-Management Arm
Participants in the intervention arm will attend eight 90-minute virtual group sessions with nurse and peer educators that will navigate them through the different self-management content.
Adfærdsmæssigt: Group Self-Management Sessions
Our targeted self-management intervention will be delivered virtually through eight 90-minute sessions over a 3-4-month period using materials adapted from previous focus groups of people with brain cancer and an expert design panel. A nurse educator and peer educator will facilitate the virtual sessions. The content covers topics focused on how to improve the quality of life in people diagnosed with brain cancer.
Andre navne:
  • Self-management intervention
Aktiv komparator: Education Only Arm
Participants in this arm will be invited to use an online learning management system to access the educational materials. There are no group sessions, and there are no nurse or peer educators that will lead the participants through the materials.
Andet: Educational Materials Only
Self-management content specifically designed for people with brain cancer will be uploaded into a learning management system. The content will be broken up into modules that will be unlocked at the same frequency as the self-management group sessions arm. There are no group sessions involved, and there are no nurse or peer educators to lead the participants through this content.
Andre navne:
  • Content only

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)
Tidsramme: Baseline, immediately post-intervention, and 3 months post-intervention
Evaluated by the change overall score of the RAND 36-Item Short Form Survey Instrument (SF-36) at baseline, immediate after intervention, and 3 months post-intervention
Baseline, immediately post-intervention, and 3 months post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress
Tidsramme: Baseline and immediately post-intervention
Change from Baseline to immediately after intervention in score of NIH Toolbox Item Bank v3.0 - Percevied Stress (Ages 18+) - Fixed Form
Baseline and immediately post-intervention
Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Tidsramme: Baseline and immediately post-intervention
Change from baseline to immediately post-intervention in score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Baseline and immediately post-intervention
Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression
Tidsramme: Baseline and immediately post-intervention
Change from baseline to immediately post-intervention of score from the Neuro-QOL Item Bank v1.0 - Depression survey
Baseline and immediately post-intervention
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form
Tidsramme: Baseline and immediately post-intervention
Change from baseline to immediately post-intervention in score from Neuro-QOL Item Bank v1.0 Fatigue - Short Form survey
Baseline and immediately post-intervention
Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function
Tidsramme: Baseline
Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys
Baseline
Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form
Tidsramme: Baseline
Baseline overall score from the Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form surveys
Baseline
Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form
Tidsramme: Baseline and immediately post-intervention
Change in score from baseline to immediately post-intervention of the Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activites - Short Form survey
Baseline and immediately post-intervention
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form
Tidsramme: Baseline and immediately post-intervention
Change in score from baseline to immediately post-intervention from the Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form survey
Baseline and immediately post-intervention
Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
Tidsramme: Baseline and immediately post-intervention
Change in score from baseline to immediately post-intervention from the PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a survey
Baseline and immediately post-intervention
Survival
Tidsramme: Immediate post-intervention, 3 months post-intervention
Self/contact-reported survival
Immediate post-intervention, 3 months post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Colorado, Denver

Samarbejdspartnere

University Hospitals Cleveland Medical Center
U.S. Army Medical Research and Development Command
Case Western Reserve University

Efterforskere

  • Ledende efterforsker: Bethany M Kwan, PhD, MSPH, University of Colorado, Denver

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

31. oktober 2027

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-2124
  • HT9425-24-1-0883 (Andet bevillings-/finansieringsnummer: U.S. Army Medical Research Acquisition Activity (USAMRAA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The datasets generated during and/or analyzed during the current study will not be publicly available, but will be available from the primary investigator on reasonable request.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjernekræft

Kliniske forsøg med Group Self-Management Sessions

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Portugal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner