- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04171609
Expressive Writing for Cancer Survivors
24. august 2020 oppdatert av: Duke University
Expressive Writing for Resilience in Adult Cancer Survivors.
The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).
Studietype
Intervensjonell
Registrering (Faktiske)
14
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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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke Integrative Medicine
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Have ever received a cancer diagnosis
- Have completed cancer treatment (e.g., surgery, radiation, or chemotherapy)
- Are able to speak, read, write, and understand English
- Are cognitively able to provide consent
- Are able to travel to Durham to participate in the 1-day writing intervention
Exclusion Criteria:
-Cancer diagnosis was skin cancer that did not require additional treatment after surgical removal
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 |
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Eksperimentell: Cancer survivors
Adult survivors of any kind of cancer (except for minor skin cancer) are eligible to participate
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During this daylong expressive writing workshop intervention, the writing instructor coached participants through a series of simple writing exercises.
Participation required neither any prior writing experience, nor any desire to become a writer.
The practices cultivate natural abilities to express the ideas that define who you are and how you experience your life.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in resilience as measured by the Connor-Davidson Resilience Scale
Tidsramme: Baseline, 6 months
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This 25-item scale addresses resilience, and has been studied in a variety of populations.
Resilience is considered as the capacity to overcome adversity.
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Baseline, 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Post-writing survey
Tidsramme: 1 day (collected during the 1-day intervention)
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This five-question survey is used after each writing exercise to measure how respondents reflect on their writing.
This survey asks participants to respond to the first four questions using a 10-point Likert-type scale endorsing the degree to which each item reflects their thoughts and feeling about their writing.
The fifth question asks for a free-response reflection on how they think and feel about how their writing went.
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1 day (collected during the 1-day intervention)
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Change in quality of life as measured by the Quality of Life Patient/Cancer Survivor Version (QOL-CSV)
Tidsramme: Baseline, 6 months
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The QOL-CSV is a 41-item ordinal scale measuring quality of life as a cancer patient that originated in use for pain research and was recently adapted for use in long-term cancer survivorship.
This survey asks participants to measure their quality of life in terms of the physical, psychological, social, and spiritual dimensions of well-being.
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Baseline, 6 months
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Change in perceived stress as measured by Perceived Stress Scale (PSS-10)
Tidsramme: Baseline, 6 months
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The PSS-10 is a well-known 10-item questionnaire used to evaluate responders' perceptions about their level of stress and their ability to cope with stress over the last month.
Results from this questionnaire have demonstrated acceptable levels of validity and reliability.
This inventory asks participants to respond using a 10-point Likert-type scale when endorsing the degree to which each item best reflects their thoughts and feelings within the past month.
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Baseline, 6 months
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Change in depression as measured by Center for Epidemiological Studies Depression Scale Revised (CESD-R)
Tidsramme: Baseline, 6 months
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The 20-item CESD-R is one of the most common screening tests that measures depressive feelings and behaviors within the past week.
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Baseline, 6 months
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Qualitative follow-up questionnaire
Tidsramme: 6 months
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This qualitative follow-up questionnaire will be administered 6 months after the study intervention to capture participants' reflections on their experience in the study.
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6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 (Faktiske)
19. juli 2019
Primær fullføring (Faktiske)
14. mai 2020
Studiet fullført (Faktiske)
14. mai 2020
Datoer for studieregistrering
Først innsendt
19. november 2019
Først innsendt som oppfylte QC-kriteriene
19. november 2019
Først lagt ut (Faktiske)
21. november 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2020
Sist bekreftet
1. november 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00101278
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .
Kliniske studier på Expressive writing
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