Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being (LWBC)
2. juni 2026 oppdatert 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?
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
64
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Research Services Professional
- Telefonnummer: 303-724-1723
- E-post: lwbc@cuanschutz.edu
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80045
- University of Colorado Anschutz
-
Ta kontakt med:
- Research Services Professional
- E-post: LWBC@cuanschutz.edu
-
Hovedetterforsker:
- Bethany M Kwan, PhD, MSPH
-
-
Ohio
-
Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center
-
Hovedetterforsker:
- Molly McVoy, MD
-
-
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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
|
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Bethany M Kwan, PhD, MSPH, University of Colorado, Denver
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
- Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
- Tollosa DN, Tavener M, Hure A, James EL. Adherence to multiple health behaviours in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2019 Jun;13(3):327-343. doi: 10.1007/s11764-019-00754-0. Epub 2019 Apr 16.
- Cramer JA, Perrine K, Devinsky O, Meador K. A brief questionnaire to screen for quality of life in epilepsy: the QOLIE-10. Epilepsia. 1996 Jun;37(6):577-82. doi: 10.1111/j.1528-1157.1996.tb00612.x.
- Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.
- Ruta D, Garratt A, Abdalla M, Buckingham K, Russell I. The SF 36 health survey questionnaire. A valid measure of health status.. BMJ. 1993 Aug 14;307(6901):448-9. doi: 10.1136/bmj.307.6901.448-b. No abstract available.
- Gershon RC, Lai JS, Bode R, Choi S, Moy C, Bleck T, Miller D, Peterman A, Cella D. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012 Apr;21(3):475-86. doi: 10.1007/s11136-011-9958-8. Epub 2011 Aug 27.
- Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26.
- Bunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1.
- Miller KD, Ostrom QT, Kruchko C, Patil N, Tihan T, Cioffi G, Fuchs HE, Waite KA, Jemal A, Siegel RL, Barnholtz-Sloan JS. Brain and other central nervous system tumor statistics, 2021. CA Cancer J Clin. 2021 Sep;71(5):381-406. doi: 10.3322/caac.21693. Epub 2021 Aug 24.
- Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF; INDIGO Trial Investigators. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601. doi: 10.1056/NEJMoa2304194. Epub 2023 Jun 4.
- Krippendorff K. Content analysis: An introduction to its methodology. Sage publications; 2013.
- Stemler S. An overview of content analysis. Practical Assessment. Research & Evaluation. 2001;7(17): 137-146.
- Gabel N, Altshuler DB, Brezzell A, Briceno EM, Boileau NR, Miklja Z, Kluin K, Ferguson T, McMurray K, Wang L, Smith SR, Carlozzi NE, Hervey-Jumper SL. Health Related Quality of Life in Adult Low and High-Grade Glioma Patients Using the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) and Neuro-QOL Assessments. Front Neurol. 2019 Mar 15;10:212. doi: 10.3389/fneur.2019.00212. eCollection 2019.
- Blixen C, Perzynski A, Kanuch S, Dawson N, Kaiser D, Lawless ME, Seeholzer E, Sajatovic M. Training peer educators to promote self-management skills in people with serious mental illness (SMI) and diabetes (DM) in a primary health care setting. Prim Health Care Res Dev. 2015 Apr;16(2):127-37. doi: 10.1017/S1463423614000176. Epub 2014 Apr 7.
- McVoy M, Delbello M, Levin J, Modi AC, Forthun LF, Briggs F, Appling D, Broadnax M, Conroy C, Cooley R, Eapen G, Sajatovic M. A customized adherence enhancement program for adolescents and young adults with suboptimal adherence and bipolar disorder: Trial design and methodological report. Contemp Clin Trials. 2022 Apr;115:106729. doi: 10.1016/j.cct.2022.106729. Epub 2022 Mar 9.
- Barr VJ, Robinson S, Marin-Link B, Underhill L, Dotts A, Ravensdale D, Salivaras S. The expanded Chronic Care Model: an integration of concepts and strategies from population health promotion and the Chronic Care Model. Hosp Q. 2003;7(1):73-82. doi: 10.12927/hcq.2003.16763.
- Reynolds R, Dennis S, Hasan I, Slewa J, Chen W, Tian D, Bobba S, Zwar N. A systematic review of chronic disease management interventions in primary care. BMC Fam Pract. 2018 Jan 9;19(1):11. doi: 10.1186/s12875-017-0692-3.
- Blixen C, Perzynski A, Cage J, Smyth K, Moore S, Sila C, Pundik S, Sajatovic M. Using focus groups to inform the development of stroke recovery and prevention programs for younger African-American (AA) men. Top Stroke Rehabil. 2015 Jun;22(3):221-30. doi: 10.1179/1074935714Z.0000000006. Epub 2015 Jan 14.
- Sajatovic M, Tatsuoka C, Welter E, Perzynski AT, Colon-Zimmermann K, Van Doren JR, Bukach A, Lawless ME, Ryan ER, Sturniolo K, Lhatoo S. Targeted Self-Management of Epilepsy and Mental Illness for individuals with epilepsy and psychiatric comorbidity. Epilepsy Behav. 2016 Nov;64(Pt A):152-159. doi: 10.1016/j.yebeh.2016.08.012. Epub 2016 Oct 12.
- Perzynski AT, Ramsey RK, Colon-Zimmermann K, Cage J, Welter E, Sajatovic M. Barriers and facilitators to epilepsy self-management for patients with physical and psychological co-morbidity. Chronic Illn. 2017 Sep;13(3):188-203. doi: 10.1177/1742395316674540. Epub 2016 Oct 19.
- Sajatovic M, Colon-Zimmermann K, Kahriman M, Fuentes-Casiano E, Burant C, Aebi ME, Cassidy KA, Lhatoo S, Einstadter D, Chen P. One-year follow-up of a remotely delivered epilepsy self-management program in high-risk people with epilepsy. Epilepsy Behav. 2019 Jul;96:237-243. doi: 10.1016/j.yebeh.2019.04.034. Epub 2019 May 21.
- Sajatovic M, Colon-Zimmermann K, Kahriman M, Fuentes-Casiano E, Liu H, Tatsuoka C, Cassidy KA, Lhatoo S, Einstadter D, Chen P. A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. Epilepsia. 2018 Sep;59(9):1684-1695. doi: 10.1111/epi.14527. Epub 2018 Aug 10.
- Sajatovic M, Tatsuoka C, Welter E, Colon-Zimmermann K, Blixen C, Perzynski AT, Amato S, Cage J, Sams J, Moore SM, Pundik S, Sundararajan S, Modlin C, Sila C. A Targeted Self-Management Approach for Reducing Stroke Risk Factors in African American Men Who Have Had a Stroke or Transient Ischemic Attack. Am J Health Promot. 2018 Feb;32(2):282-293. doi: 10.1177/0890117117695218. Epub 2017 Mar 6.
- Still CH, Burant C, Moore S, Einstadter D, Killion C, Modlin C, Sundararajan S, Thornton JD, Wright JT Jr, Sajatovic M. The Targeted Management (TEAM) Intervention for Reducing Stroke Risk in African American Men: Rationale and Study Design of a Prospective Randomized Controlled Trial. J Multidiscip Healthc. 2021 Feb 23;14:513-522. doi: 10.2147/JMDH.S288753. eCollection 2021.
- Kottapalli I, Needham K, Colon-Zimmermann K, Richter N, Schrag K, Ryan ER, Storer N, Sarna K, Briggs FBS, Rentsch J, Sajatovic M. A community-targeted implementation of self-management for people with epilepsy and a history of negative health events (SMART): A research and community partnership to reduce epilepsy burden. Epilepsy Behav. 2022 Jan;126:108440. doi: 10.1016/j.yebeh.2021.108440. Epub 2021 Dec 15.
- Sajatovic M, Gunzler DD, Kanuch SW, Cassidy KA, Tatsuoka C, McCormick R, Blixen CE, Perzynski AT, Einstadter D, Thomas CL, Lawless ME, Martin S, Falck-Ytter C, Seeholzer EL, McKibben CL, Bauer MS, Dawson NV. A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus. Psychiatr Serv. 2017 Sep 1;68(9):883-890. doi: 10.1176/appi.ps.201600377. Epub 2017 May 15.
- Kwan BM, Rementer J, Richie N, Nederveld AL, Phimphasone-Brady P, Sajatovic M, Nease DE Jr, Waxmonsky JA. Adapting Diabetes Shared Medical Appointments to Fit Context for Practice-Based Research (PBR). J Am Board Fam Med. 2020 Sep-Oct;33(5):716-727. doi: 10.3122/jabfm.2020.05.200049.
- Jost J, Muther M, Brandt R, Altuner U, Lemcke L, Stummer W, Volker K, Wiewrodt R, Wiewrodt D. Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. J Neurooncol. 2023 Jun;163(2):367-376. doi: 10.1007/s11060-023-04354-y. Epub 2023 Jun 12.
- Sandler CX, Matsuyama M, Jones TL, Bashford J, Langbecker D, Hayes SC. Physical activity and exercise in adults diagnosed with primary brain cancer: a systematic review. J Neurooncol. 2021 May;153(1):1-14. doi: 10.1007/s11060-021-03745-3. Epub 2021 Apr 28.
- Knobf MT, Musanti R, Dorward J. Exercise and quality of life outcomes in patients with cancer. Semin Oncol Nurs. 2007 Nov;23(4):285-96. doi: 10.1016/j.soncn.2007.08.007.
- Bartholomew JB, Morrison D, Ciccolo JT. Effects of acute exercise on mood and well-being in patients with major depressive disorder. Med Sci Sports Exerc. 2005 Dec;37(12):2032-7. doi: 10.1249/01.mss.0000178101.78322.dd.
- Moses J, Steptoe A, Mathews A, Edwards S. The effects of exercise training on mental well-being in the normal population: a controlled trial. J Psychosom Res. 1989;33(1):47-61. doi: 10.1016/0022-3999(89)90105-0.
- Jeon MS, Agar MR, Koh ES, Nowak AK, Hovey EJ, Dhillon HM. Barriers to managing sleep disturbance in people with malignant brain tumours and their caregivers: a qualitative analysis of healthcare professionals' perception. Support Care Cancer. 2021 Jul;29(7):3865-3876. doi: 10.1007/s00520-020-05970-4. Epub 2021 Jan 2.
- Jeon MS, Agar MR, Koh ES, Nowak AK, Hovey EJ, Dhillon HM. Understanding sleep disturbance in the context of malignant brain tumors: a qualitative analysis. Neurooncol Pract. 2020 Nov 29;8(2):179-189. doi: 10.1093/nop/npaa081. eCollection 2021 Apr.
- Guo A, Asztely F, Smits A, Jakola AS. Methodological Approaches to Ketogenic Dietary Treatments in Glioma Patients from a Nutritional Point of View. Nutr Cancer. 2023;75(1):112-122. doi: 10.1080/01635581.2022.2108073. Epub 2022 Aug 12.
- Voss M, Wenger KJ, von Mettenheim N, Bojunga J, Vetter M, Diehl B, Franz K, Gerlach R, Ronellenfitsch MW, Harter PN, Hattingen E, Steinbach JP, Rodel C, Rieger J. Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Eur J Nutr. 2022 Feb;61(1):477-487. doi: 10.1007/s00394-021-02666-1. Epub 2021 Sep 6.
- Piil K, Jakobsen J, Christensen KB, Juhler M, Guetterman TC, Fetters MD, Jarden M. Needs and preferences among patients with high-grade glioma and their caregivers - A longitudinal mixed methods study. Eur J Cancer Care (Engl). 2018 Mar;27(2):e12806. doi: 10.1111/ecc.12806. Epub 2018 Jan 4.
- Li Q, Zhang L, Chen C, Gan Y, Jiang L, Li S, Xiang W, Ming Y, Yang C, Zhou J. Caregiver burden and influencing factors among family caregivers of patients with glioma: A cross-sectional survey. J Clin Neurosci. 2022 Feb;96:107-113. doi: 10.1016/j.jocn.2021.11.012. Epub 2021 Nov 25.
- Ownsworth T, Chambers S, Damborg E, Casey L, Walker DG, Shum DH. Evaluation of the making sense of brain tumor program: a randomized controlled trial of a home-based psychosocial intervention. Psychooncology. 2015 May;24(5):540-7. doi: 10.1002/pon.3687. Epub 2014 Sep 23.
- Kangas M. Psychotherapy Interventions for Managing Anxiety and Depressive Symptoms in Adult Brain Tumor Patients: A Scoping Review. Front Oncol. 2015 May 21;5:116. doi: 10.3389/fonc.2015.00116. eCollection 2015.
- Hickmann AK, Hechtner M, Nadji-Ohl M, Janko M, Reuter AK, Kohlmann K, Haug M, Gruninger S, Deininger M, Ganslandt O, Konig J, Wirtz CR, Coburger J, Renovanz M. Evaluating patients for psychosocial distress and supportive care needs based on health-related quality of life in primary brain tumors: a prospective multicenter analysis of patients with gliomas in an outpatient setting. J Neurooncol. 2017 Jan;131(1):135-151. doi: 10.1007/s11060-016-2280-0. Epub 2016 Sep 16.
- Langbecker D, Yates P. Primary brain tumor patients' supportive care needs and multidisciplinary rehabilitation, community and psychosocial support services: awareness, referral and utilization. J Neurooncol. 2016 Mar;127(1):91-102. doi: 10.1007/s11060-015-2013-9. Epub 2015 Dec 7.
- Otto-Meyer S, Lumibao J, Kim E, Ladomersky E, Zhai L, Lauing KL, Scholtens DM, Penedo F, Amidei C, Lukas RV, Wainwright DA. The interplay among psychological distress, the immune system, and brain tumor patient outcomes. Curr Opin Behav Sci. 2019 Aug;28:44-50. doi: 10.1016/j.cobeha.2019.01.009. Epub 2019 Feb 26.
- Webster Marketon JI, Glaser R. Stress hormones and immune function. Cell Immunol. 2008 Mar-Apr;252(1-2):16-26. doi: 10.1016/j.cellimm.2007.09.006. Epub 2008 Feb 14.
- Bhanja D, Ba D, Tuohy K, Wilding H, Trifoi M, Padmanaban V, Liu G, Sughrue M, Zacharia B, Leslie D, Mansouri A. Association of Low-Grade Glioma Diagnosis and Management Approach with Mental Health Disorders: A MarketScan Analysis 2005-2014. Cancers (Basel). 2022 Mar 8;14(6):1376. doi: 10.3390/cancers14061376.
- Hartung TJ, Brahler E, Faller H, Harter M, Hinz A, Johansen C, Keller M, Koch U, Schulz H, Weis J, Mehnert A. The risk of being depressed is significantly higher in cancer patients than in the general population: Prevalence and severity of depressive symptoms across major cancer types. Eur J Cancer. 2017 Feb;72:46-53. doi: 10.1016/j.ejca.2016.11.017. Epub 2016 Dec 23.
- Singer S, Roick J, Danker H, Kortmann RD, Papsdorf K, Taubenheim S, Renovanz M, Jahne K, Meixensberger J. Psychiatric co-morbidity, distress, and use of psycho-social services in adult glioma patients-a prospective study. Acta Neurochir (Wien). 2018 Jun;160(6):1187-1194. doi: 10.1007/s00701-018-3527-7. Epub 2018 Mar 29.
- Huang J, Zeng C, Xiao J, Zhao D, Tang H, Wu H, Chen J. Association between depression and brain tumor: a systematic review and meta-analysis. Oncotarget. 2017 Aug 3;8(55):94932-94943. doi: 10.18632/oncotarget.19843. eCollection 2017 Nov 7.
- Liu F, Huang J, Zhang L, Fan F, Chen J, Xia K, Liu Z. Screening for distress in patients with primary brain tumor using distress thermometer: a systematic review and meta-analysis. BMC Cancer. 2018 Feb 2;18(1):124. doi: 10.1186/s12885-018-3990-9.
- Young JS, Al-Adli N, Sibih YE, Scotford KL, Casey M, James S, Berger MS. Recognizing the psychological impact of a glioma diagnosis on mental and behavioral health: a systematic review of what neurosurgeons need to know. J Neurosurg. 2022 Nov 4;139(1):11-19. doi: 10.3171/2022.9.JNS221139. Print 2023 Jul 1.
- Aaronson NK, Taphoorn MJ, Heimans JJ, Postma TJ, Gundy CM, Beute GN, Slotman BJ, Klein M. Compromised health-related quality of life in patients with low-grade glioma. J Clin Oncol. 2011 Nov 20;29(33):4430-5. doi: 10.1200/JCO.2011.35.5750. Epub 2011 Oct 17.
- Salmi L, Lum HD, Hayden A, Reblin M, Otis-Green S, Venechuk G, Morris MA, Griff M, Kwan BM. Stakeholder engagement in research on quality of life and palliative care for brain tumors: a qualitative analysis of #BTSM and #HPM tweet chats. Neurooncol Pract. 2020 Jul 29;7(6):676-684. doi: 10.1093/nop/npaa043. eCollection 2020 Dec.
- Boele FW, den Otter PWM, Reijneveld JC, de Witt Hamer PC, van Thuijl HF, Lorenz LMC, Wesseling P, Lagerwaard FJ, Taphoorn MJB, Kouwenhoven MCM, Snijders TJ, Douw L, Klein M. Long-term wellbeing and neurocognitive functioning of diffuse low-grade glioma patients and their caregivers: A longitudinal study spanning two decades. Neuro Oncol. 2023 Feb 14;25(2):351-364. doi: 10.1093/neuonc/noac185.
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 (Antatt)
1. juni 2026
Primær fullføring (Antatt)
31. oktober 2027
Studiet fullført (Antatt)
31. oktober 2027
Datoer for studieregistrering
Først innsendt
26. mai 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Neoplasmer i nervesystemet
- Neoplasmer i sentralnervesystemet
- Oppførsel
- Personlig tilfredshet
- Glioblastom
- Glioma
- Neoplasmer i hjernen
- Astrocytom
- Ependymom
- Oligodendrogliom
- Psykologisk velvære
Andre studie-ID-numre
- 25-2124
- HT9425-24-1-0883 (Annet stipend/finansieringsnummer: U.S. Army Medical Research Acquisition Activity (USAMRAA))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .