- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07724041
Feasibility of a Real-world, Financial Psycho-oncology Intervention to Address Cancer-related Financial Distress
The goal of this pilot, feasibility study is to evaluate the feasibility and preliminary impact of a finance-specific psycho-oncology intervention, as well as to explore perceptions of and experiences with this financial psycho-oncology intervention for patients with cancer experiencing financial hardship. The main questions it aims to answer are:
- Is this financial psycho-oncology intervention feasible, acceptable, and appropriate for patients with cancer experiencing financial hardship?
- How can we refine the financial psycho-oncology intervention to best address financial distress for patients with cancer experiencing financial hardship?
Patients enrolled in the intervention will receive 2, 60-minute long, finance-specific psycho-oncology sessions per month over the course of 3 months, for a total of 6 sessions over the course of the intervention. Patients will complete surveys during intervention enrollment and after intervention completion to assess secondary outcomes of financial hardship, psychological distress, stress, and anxiety. Individuals who consent to the financial psycho-oncology intervention will also be invited to participate in a 30-minute semi-structured interview to explore their perceptions of and experiences with the financial psycho-oncology intervention, including concepts of participation and engagement, relevance and acceptability, content and understanding, logistics and practicality, and potential impact.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hayden Reeves
- Telefonnummer: 205-996-4109
- E-mail: haydenreeves@uabmc.edu
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham
-
Kontakt:
- Hayden Reeves
- Telefonnummer: 205-996-4109
- E-mail: haydenreeves@uabmc.edu
-
Ledende efterforsker:
- Courtney Williams, DrPH
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adult patients with cancer receiving treatment at the UAB Medical Oncology and/or UAB Supportive Care clinics
Exclusion Criteria:
- non-English speakers
- patients with non-melanoma skin cancers
- patients with dementia/cognitive impairments
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Patients receiving financial psycho-oncology intervention
|
Program which integrates emotional support, coping strategies, and financial psychoeducation to enhance patients' capacity to cope with both their emotional and financial burdens due to cancer.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment as a measure of feasibility
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
50% of contacted patients consenting to participate
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Retention as a measure of feasibility
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
70% of consenting patients completing the program per protocol
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Completion as a measure of feasibility
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
<15% missing survey data
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Financial hardship
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by COmprehensive Score for financial Toxicity (COST)
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Psychological distress
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by National Comprehensive Cancer Network Distress Thermometer and Problem List
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Perceived stress
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by Perceived Stress Scale (PSS-10)
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Anxiety
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by PROMIS Emotional Distress - Anxiety - Short Form 4
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Depression
Tidsramme: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by PROMIS Emotional Distress - Depression - Short Form 4
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Courtney Williams, DrPH, University of Alabama at Birmingham
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PREP_Williams2026
- UAB (Anden identifikator: UAB)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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