Redes III Patient Navigator Qol Study
Improving Quality of Life Among Hispanic/Latino Breast, Colorectal & Prostate Cancer Survivors: A Randomized Control Trial of Patient Navigators Using the LIVESTRONG Cancer Navigation Services Program
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60201
- Northwestern University
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Texas
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San Antonio, Texas, Stati Uniti, 78229
- The University of Texas Health Science Center at San Antonio
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Self identified Hispanic/Latino
- At least 18 yrs old
- Fluent in spoken Spanish or English
- Diagnosed with breast, prostate or colorectal cancer within the past fifteen months and thus considered a cancer survivor and are currently not undergoing treatment, with the exception of hormone therapy for prostate patients
- No evidence of metastatic disease
- No current severe mental illness
- No substance dependence within the past year -
Exclusion Criteria:
- Does not meet inclusion criteria
- Psychotic Disorder
- Active Suicidal Ideation
- Substance dependence (alcohol/drugs) within the past 12 months
- Does not meet the requisite cutoff of 3 or more correct responses on SPMSQ (Short Portable Mental Status Questionnaire)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: PN+LCNC
Patient Navigation plus LIVESTRONG Cancer Navigation Center (PN+LCNC): Participants assigned to this group will be assisted by the patient navigator with their health-related needs.
The patient navigator will call the study participant on a weekly basis for the first three months of their participation in the study, and on a monthly basis thereafter to see if study participant needs anything pertaining to their cancer care.
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Patient Navigation plus LIVESTRONG Cancer Navigation Center (PN+LCNC): Participants assigned to this group will be assisted by the patient navigator with their health-related needs.
The patient navigator will call the study participant on a weekly basis for the first three months of their participation in the study, and on a monthly basis thereafter to see if study participant needs anything pertaining to their cancer care.
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Comparatore attivo: PN only
Patient Navigation ONLY.
Participants assigned to this group will be assisted by the patient navigator with their health-related needs.
Navigation will occur ONLY on contact with navigators initiated by the study participants.
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Participants will be navigated by PN on request
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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General quality of life
Lasso di tempo: 15 months
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The Functional Assessment of Cancer Therapy-General (FACT-G) will be administered to evaluate general domains of QOL.
The FACT-G, now in its fourth revision, is one of the most widely used instruments to assess overall adjustment to cancer treatment and survivorship.
It is a 27-item self-report questionnaire that takes less than 15 minutes to administer.
The FACT-G assesses QOL in four domains of well-being: physical, social/family, emotional and functional well-being.
Patients are asked to indicate the extent to which they agree with statements such as "I have pain," "I feel ill," "I get emotional support from my family," "I get support from my friends," "I feel sad," "I feel nervous," "I am sleeping well," and "I am content with the quality of my life right now."
The scale is validated for use in many settings with many age groups.
We will calculate a composite score for general QOL as well as subscale scores for specific domains of QOL.
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15 months
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Disease specific quality of life
Lasso di tempo: 15 months
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We will administer three cancer-specific FACT versions, the FACT-B (breast cancer survivors), FACT-C (colorectal cancer survivors) or FACT-P (prostate cancer survivors).
Each version addresses QOL issues that are common sequelae of that certain cancer.
For example, the FACT-P evaluates concerns on sexuality, pain, and bowel and bladder function, the FACT-C asks questions about bowel movement control, weight loss and cramping in the abdominal area, and the FACT-B inquires about hair loss, shortness of breath and swelling in the arms.
Reliability of the FACT-G, as well as all cancer site-specific FACT measures are acceptable (Cronbach's α>.70).
Composite scores for disease-specific QOL will be calculated across each cancer site.
Cancer site specific modules scores are standardized and can be combined across cancer sites.
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15 months
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Treatment Follow-up compliance
Lasso di tempo: 15 months
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Because all of our HL cancer survivors will be recruited within 12-months post-treatment completion for a primary tumor, we will follow ACS guidelines for follow-up care for one- to two-years post-treatment.
We will assess via self-report whether the participant missed a scheduled follow-up appointment during the study period.
A compliance categorical outcome measure (compliant vs. non-compliant) will be calculated for each participant.
Compliance will be defined as attending all scheduled follow-up appointments specific to cancer treatment follow-up during the study period.
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15 months
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Amelie G Ramirez, DRPH, The University of Texas Health Science Center at San Antonio
- Direttore dello studio: Frank Penedo, PhD, Northwestern University
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- HSC20110094H
- U54CA153511 (Sovvenzione/contratto NIH degli Stati Uniti)
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