Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
11. juli 2017 oppdatert av: Marla L Clayman, Northwestern University
Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The team has developed a brief Patient Participation Aid (PPA) to promote patient health literacy and encourage women to be active in the decisions that are being made about their healthcare which will lead to their satisfaction with healthcare and improves their psychosocial well-being.
The paper-based PPA uses adult learning principles to limit and sequence plain language messages that have been framed from a patient's perspective.
The PPA uses theory-based design to increase patients' involvement in the medical visit by modeling - through text and images - how a patient can: 1) set the visit agenda, 2) formulate questions, and 3) assert personal preferences.
The specific aims of this study are to: 1- Assess the effectiveness of the PPA to increase patient involvement during clinical encounters.
2- Evaluate the effectiveness of the PPA to improve patient psychosocial outcomes.
3- Explore if the effect of the PPA varies by patients' literacy skills.
To achieve this aims, the investigators will conduct a randomized controlled trial to evaluate the PPA among patients with a new diagnosis or progression of metastatic breast cancer at two cancer centers that serve diverse patient populations.
Studietype
Intervensjonell
Registrering (Faktiske)
150
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Tampa, Florida, Forente stater, 33612
- H Lee Moffitt Comprehensive Cancer Center
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Louisiana
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Shreveport, Louisiana, Forente stater, 71103
- Feist-Weiller Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics
- age 21 or older
- having suspected progression of metastatic disease
Exclusion Criteria:
- patients with an uncorrectable hearing impairment or having limited English proficiency, as this would adversely affect their ability to communicate with the physician
- patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention
- patients too ill to meaningfully converse with the physician
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention
Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy.
Then they will be helped through the Patient-Participation Aid (PPA) by the research assistant (RA).
Then they will meet with their doctor while the visit is video-recorded.
After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication.
Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.
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The PPA consists of a folder that addresses the three behaviors we hope to influence: agenda setting, asking questions, and making preferences known.
The information inside contains sample questions for each section, with room for the patient to write her own questions.
Each section models behavior by giving context for the items and specific example questions.
It also addresses barriers to understanding by indicating that it is acceptable to ask questions when something is not clear or terms are unfamiliar.
Andre navn:
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Ingen inngripen: Usual Care
Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy.
They will have their doctor's visit video recorded.
After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication.Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Assessment of Cancer Therapy - General (FACT-G)
Tidsramme: Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit
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Evaluated at 30 minutes prior to, one week after, and 3 months after the patients visit with their doctor, this measure collects scales of the social and family well-being, emotional well-being, and functional well-being.
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Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rapid Estimate of Adult Literacy in Medicine (REALM-SF)
Tidsramme: Pre-Visit
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A 7-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy.
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Pre-Visit
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Decision Regret Scale
Tidsramme: Change in decision regret from pre-visit at 3 months post-visit
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Collected at post-visit, and follow-ups, this measures the patient's regret and feelings regarding the most recent treatment-related decision
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Change in decision regret from pre-visit at 3 months post-visit
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marla Clayman, Ph.D, Northwestern University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2013
Primær fullføring (Faktiske)
19. mai 2017
Studiet fullført (Faktiske)
19. mai 2017
Datoer for studieregistrering
Først innsendt
19. februar 2013
Først innsendt som oppfylte QC-kriteriene
12. mars 2013
Først lagt ut (Anslag)
14. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. juli 2017
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PPA Study
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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