- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Hayden Reeves
- Numero di telefono: 205-996-4109
- Email: haydenreeves@uabmc.edu
Luoghi di studio
-
-
Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- University of Alabama at Birmingham
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Contatto:
- Hayden Reeves
- Numero di telefono: 205-996-4109
- Email: haydenreeves@uabmc.edu
-
Investigatore principale:
- Courtney Williams, DrPH
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recruitment as a measure of feasibility
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Financial hardship
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Courtney Williams, DrPH, University of Alabama at Birmingham
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PREP_Williams2026
- UAB (Altro identificatore: UAB)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .