Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers
4 maj 2018 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
3
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Complete W2W mentoring program
Andra namn:
Complete the FACT-G
Andra namn:
Complete the W2W Patient Survey
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in quality of life benefits for patients, as assessed by the FACT-G
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Thanh Dellinger, MD, City of Hope Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2015
Primärt slutförande (Faktisk)
1 april 2018
Avslutad studie (Faktisk)
1 april 2018
Studieregistreringsdatum
Först inskickad
3 april 2015
Först inskickad som uppfyllde QC-kriterierna
7 april 2015
Första postat (Uppskatta)
8 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14359 (Annan identifierare: City of Hope Medical Center)
- NCI-2015-00467 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .