- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00983892
Care Partners: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy
Web-based Support for Caregivers of Veterans Undergoing Chemotherapy
Panoramica dello studio
Descrizione dettagliata
Cancer is a prevalent problem that causes much suffering among Veterans and their families. Most interventions to improve symptom control require Veterans to engage in activities such as managing medications, altering diets, or accessing outside resources that may be beyond their reach due to limitations in physical and mental functioning. Friends and family inside and outside of the Veteran's household can help, but often lack the skills and resources they need to do so.
"Cancer CarePartners" was designed to address these needs by providing cancer-stricken Veterans and their informal caregivers with the information they need to make effective management decisions, decrease symptom burden, and improve outcomes. Cancer CarePartners is a Web-enabled program that alerts caregivers of patients' symptoms and provides them with a framework for identifying problems, receiving structured advice, formulating a 'task list,' and following up with their patients as they receive chemotherapy. Specifically, Cancer CarePartners includes weekly, automated telephonic symptom assessment (ATSA) with self-management (SM) support to the Veteran paired with Web-based alerts to the caregiver pointing them to a website where s/he can obtain customized advice. A randomized control trial was conducted to test the efficacy of this program in controlling symptoms as well as improving adherence to chemotherapy.
Objectives
1) To determine if Veterans undergoing chemotherapy who receive Cancer CarePartners report significant improvement in the summed severity of symptoms (the sum of 0-10 severity across 8 core symptoms) compared to Veterans receiving symptom monitoring and self-management advice; secondarily, to determine if they experience better adherence to chemotherapy and utilization. (2) To determine if caregivers participating in the intervention provide significantly more social support to patients than do controls; secondarily, to determine if they experience more caregiver burden and distress than do controls. (3) To determine whether impacts on patients are mediated by mastery. (4) To determine whether impacts on caregivers are mediated by mastery.
Methods Consenting Veterans with solid tumors undergoing chemotherapy at one of three VAMCs (Ann Arbor, Loma Linda and Fargo) who reported at least one core symptom at a moderate level or higher and had a caregiver willing to enroll in the study were randomly assigned to either 10 weeks of Cancer CarePartners or 10 weeks of automated, telephonic symptom assessment (ATSA) with self management support. Arms were balanced for non-small cell lung cancer status and caregiver type. Patients and caregivers were surveyed at intake, 10, and 14 weeks. In addition, the investigators tracked patient participation with ATSA and (in the experimental arm) caregiver use of the Cancer CarePartners Website. The investigators reviewed all medical records for content of care received during the 14 weeks on study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Loma Linda, California, Stati Uniti, 92357
- VA Loma Linda Healthcare System, Loma Linda, CA
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients must be 18 years or older, cognitively intact, English-speaking, able to hear, and own a telephone.
- Patients can have any solid tumor.
- Patients must be initiating IV cytotoxic chemotherapy and, if recurrent, have experienced a 1 month treatment free interval.
- Caregivers must be 18 years or older, cognitively intact, English-speaking, and able to hear/speak for interviews.
- Caregivers must have access to a telephone and computer with high speed internet access.
Exclusion Criteria:
- Patients will be excluded if they have a hematologic malignancy or are receiving bone marrow transplantation.
- Patients and caregivers will be excluded if they have an untreated serious mental illness or cognitive impairment, are institutionalized or enrolled in hospice (prior to trial), or plan on not receiving all care from VA
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: CarePartners+
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive the intervention (Intervention = access to a caregiver Web site that updates them on patient's symptoms and provides tailored problem solving advice).
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Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan.
Altri nomi:
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Nessun intervento: CarePartners-
Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing (i.e.
no access to the caregiver website, or 'intervention').
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Summed Symptom Severity
Lasso di tempo: 3 months
|
Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory.
8 core symptoms rated by the patient on a scale of 0 to 10.
These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest.
Higher scores mean WORSE or GREATER SYMPTOM BURDEN.
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3 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Maria J. Silveira, MD MA MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IIR 08-309
Piano per i dati dei singoli partecipanti (IPD)
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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 .