Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer
18. juni 2026 opdateret af: City of Hope Medical Center
This study evaluates how useful and acceptable the components of the "Couples Coping Together Against Cancer", referred to as "The Program", are to the participants with cancer.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Establish feasibility of The Program and its central components. II. Investigate the acceptability of The Program and its central components.
EXPLORATORY OBJECTIVE:
I. Assess the preliminary efficacy of The Program in the domain of patients' and partners' biopsychosocial distress and longitudinal impact of the program on them.
OUTLINE: This is an observational study.
Patient and partners receive access to the Connecting Care App tool and undergo biopsychosocial screening and psychoeducation sessions over 30-45 minutes and complete surveys on study. Patients and partners may also receive counseling sessions over 30-45 minutes for up to 4 sessions on study.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
160
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope Medical Center
-
Ledende efterforsker:
- William Dale
-
Kontakt:
- William Dale
- Telefonnummer: 85153 626-256-4673
- E-mail: wdale@coh.org
-
-
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
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with glioblastoma, breast cancer, lung cancer, or other cancer, their partners, and their providers
Beskrivelse
Inclusion Criteria:
- Have received a diagnosis of a primary brain tumor (glioblastoma), or other cancers (breast, lung, etc.)
- Are new patients to City of Hope (COH) (all sites) or receive at least some of their care at City of Hope- Duarte Campus (care is defined as: procedures, consults, laboratories, imaging, surgery, and/or treatment)
- The patient is in a committed relationship/partnership with a partner and the partner is available and willing to participate
- Are English or Spanish speaking
- ≥ 18 years of age
- Have access to a smartphone, computer/laptop or internet connection to complete all study procedures
Exclusion Criteria:
- Significant cognitive impairment
- Inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis)
- Visual, hearing, voice, or motor impairment that prevents completion of study procedures as evidenced by clinical judgment
Committed partners will be excluded from the study if they:
- Refuse to complete informed consent
- Have cognitive impairment
- Have severe mental illness that would prevent informed consent and completion of study activities as evidenced by clinical judgment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Observational
Patient and partners receive access to the Connecting Care App tool and undergo biopsychosocial screening and psychoeducation sessions over 30-45 minutes and complete surveys on study.
Patients and partners may also receive counseling sessions over 30-45 minutes for up to 4 sessions on study.
|
Ikke-interventionel undersøgelse
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accrual rate (AR)
Tidsramme: Up to 12 months
|
Defined as number of enrolled dyads/number of eligible dyads x 100.
Recruitment rate along with 95% confidence interval (CI) will be calculated.
Program will be considered feasible with ≥ 70% recruitment rate.
|
Up to 12 months
|
|
Retention rate (RR)
Tidsramme: At 3 month and 6 month follow up
|
Defined as percentage of dyads retained at the 3-month follow-up.
Retention rate along with 95% CI will be calculated.
Program will be considered feasible with ≥ 70% retention rate.
|
At 3 month and 6 month follow up
|
|
Adherence rate (AdR)
Tidsramme: Up to 3 month follow up
|
Defined as percentage of dyads who completed all core components of the study at the 3-month follow-up.
Adherence rate along with 95% CI will be calculated.
Program will be considered feasible with ≥ 70% adherence rate.
|
Up to 3 month follow up
|
|
Study Satisfaction (SS)
Tidsramme: Up to 6 month follow up
|
Defined by the percentage of respondents (patients, partners, providers and staff) who scored positively on various surveys assessing study satisfaction (e.g.
agree to strongly agree or helpful to very helpful).
A rate of 70% will be considered acceptable Acceptability will be measured using a survey on study satisfaction.
Acceptability rate will be computed with 95% CI.
|
Up to 6 month follow up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in distress scores
Tidsramme: At baseline and up to 6 months post program
|
Efficacy will be evaluated via paired t-test.
Linear mixed models will also be used to explore the change in distress measures from baseline to 3 and 6 months.
|
At baseline and up to 6 months post program
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: William Dale, City of Hope Medical Center
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 (Faktiske)
5. juli 2024
Primær færdiggørelse (Anslået)
16. november 2026
Studieafslutning (Anslået)
16. november 2026
Datoer for studieregistrering
Først indsendt
16. juni 2024
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Lungesygdomme
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Hudsygdomme
- Brystsygdomme
- Astrocytom
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Hud- og bindevævssygdomme
- Lungeneoplasmer
- Brystneoplasmer
- Glioblastom
Andre undersøgelses-id-numre
- 23430 (Anden identifikator: City of Hope Medical Center)
- P30CA033572 (U.S. NIH-bevilling/kontrakt)
- NCI-2024-04490 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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