Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being (LWBC)
2 juni 2026 uppdaterad av: 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?
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
64
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Research Services Professional
- Telefonnummer: 303-724-1723
- E-post: lwbc@cuanschutz.edu
Studieorter
-
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Anschutz
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Kontakt:
- Research Services Professional
- E-post: LWBC@cuanschutz.edu
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Huvudutredare:
- Bethany M Kwan, PhD, MSPH
-
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals Cleveland Medical Center
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Huvudutredare:
- Molly McVoy, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
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.
Andra namn:
|
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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.
|
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)
Tidsram: Baseline, immediately post-intervention, and 3 months post-intervention
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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
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Baseline, immediately post-intervention, and 3 months post-intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress
Tidsram: Baseline and immediately post-intervention
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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
|
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Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Tidsram: 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
|
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Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression
Tidsram: Baseline and immediately post-intervention
|
Change from baseline to immediately post-intervention of score from the Neuro-QOL Item Bank v1.0 - Depression survey
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Baseline and immediately post-intervention
|
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Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form
Tidsram: Baseline and immediately post-intervention
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Change from baseline to immediately post-intervention in score from Neuro-QOL Item Bank v1.0 Fatigue - Short Form survey
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Baseline and immediately post-intervention
|
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Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function
Tidsram: Baseline
|
Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys
|
Baseline
|
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Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form
Tidsram: 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
|
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Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form
Tidsram: Baseline and immediately post-intervention
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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
|
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Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form
Tidsram: 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
|
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Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
Tidsram: 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
|
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Survival
Tidsram: Immediate post-intervention, 3 months post-intervention
|
Self/contact-reported survival
|
Immediate post-intervention, 3 months post-intervention
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Bethany M Kwan, PhD, MSPH, University of Colorado, Denver
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
31 oktober 2027
Avslutad studie (Beräknad)
31 oktober 2027
Studieregistreringsdatum
Först inskickad
26 maj 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
5 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 maj 2026
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Nyckelord
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- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Neoplasmer i nervsystemet
- Neoplasmer i centrala nervsystemet
- Beteende
- Personlig tillfredställelse
- Glioblastom
- Gliom
- Neoplasmer i hjärnan
- Astrocytom
- Ependymom
- Oligodendrogliom
- Psykologiskt välmående
Andra studie-ID-nummer
- 25-2124
- HT9425-24-1-0883 (Annat bidrag/finansieringsnummer: U.S. Army Medical Research Acquisition Activity (USAMRAA))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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