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Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers

4. mai 2018 oppdatert av: City of Hope Medical Center

Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer

This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?

OUTLINE:

Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.

After completion of study, patients are followed up at 6 and 12 months.

Studietype

Intervensjonell

Registrering (Faktiske)

3

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • City of Hope Medical Center

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

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • PATIENT PARTICIPANTS
  • Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
  • English-speaking patients
  • PEER MENTORS
  • Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
  • Over age 18
  • PEER MENTORS: English-speaking patients
  • This study is open to patients of all races and ethnicities

Exclusion Criteria:

  • PEER MENTORS:
  • Major psychiatric disease
  • Currently undergoing treatment for active gynecologic cancer

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Supportive care (W2W program)
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
Fremgangsmåte: Supportive Care
Complete W2W mentoring program
Andre navn:
  • Støttende terapi
  • Symptombehandling
  • Terapi, støttende
Annen: Quality-of-Life Assessment
Complete the FACT-G
Andre navn:
  • Livskvalitetsvurdering
Annen: Questionnaire Administration
Complete the W2W Patient Survey

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in quality of life benefits for patients, as assessed by the FACT-G
Tidsramme: Baseline to up to 12 months
Changes from baseline will be tested using paired t-tests. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Baseline to up to 12 months
Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey
Tidsramme: Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Up to 12 months
Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
Tidsramme: Up to 12 months
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Up to 12 months
Satisfaction of patients' family caregivers with the timing, content, and format of the program
Tidsramme: Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Up to 12 months
Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index
Tidsramme: Up to 12 months
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Up to 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

City of Hope Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Thanh Dellinger, MD, City of Hope Medical Center

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. juli 2015

Primær fullføring (Faktiske)

1. april 2018

Studiet fullført (Faktiske)

1. april 2018

Datoer for studieregistrering

Først innsendt

3. april 2015

Først innsendt som oppfylte QC-kriteriene

7. april 2015

Først lagt ut (Anslag)

8. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 14359 (Annen identifikator: City of Hope Medical Center)
  • NCI-2015-00467 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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