- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hayden Reeves
- Telefoonnummer: 205-996-4109
- E-mail: haydenreeves@uabmc.edu
Studie Locaties
-
-
Alabama
-
Birmingham, Alabama, Verenigde Staten, 35233
- University of Alabama at Birmingham
-
Contact:
- Hayden Reeves
- Telefoonnummer: 205-996-4109
- E-mail: haydenreeves@uabmc.edu
-
Hoofdonderzoeker:
- Courtney Williams, DrPH
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Recruitment as a measure of feasibility
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Financial hardship
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Courtney Williams, DrPH, University of Alabama at Birmingham
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PREP_Williams2026
- UAB (Andere identificatie: UAB)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .