Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Cancer Patients
Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Patients Who Have Received and Completed Chemotherapy Treatment With Curative Intent. A Pilot Study.
Studieoversikt
Detaljert beskrivelse
Solid tumor cancer patients who have completed chemotherapy with curative intent experience psychological distress. As a result these patients experience poorer quality of life (QOL), emotional vulnerability and unnecessary emotional suffering.
Purpose: To determine whether the implementation of a nurse driven psycho-oncological educational session will decrease psychological distress levels and improve QOL among solid tumor cancer patients who have received and completed chemotherapy with curative intent.
Methods: A randomized clinical trial (RCT) consisting of 28 eligible patients at Sibley Memorial Hospital will be used to compare the effect of psycho-oncological education to treatment as usual in reducing psychological distress and improving quality of life. The intervention group will receive one 60 minute session of psycho-oncological education. The comparison group will receive usual care only which includes a general information session offered prior to any treatment which addresses broad side-effects of treatment, an overview of the treatment process and identification of additional resources. Participants will be assessed for psychological distress and QOL levels at baseline and two weeks after the intervention.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- non-race specific
- solid tumor cancer patient
- completed chemotherapy with curative intent
Exclusion Criteria:
- diagnosis of cancer prior to cancer they are being treated for
- distress score of 8 or greater
- diagnosed with a psychiatric disorder
- diagnosed with lymphoma or leukemia
- in need of immediate crisis support
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Psycho-oncological education
One 60 minute psycho-oncological education session on late effects, fatigue and stress management.
|
One 60 minute psycho-oncological educational session on stress management, late effects and fatigue.
|
|
Ingen inngripen: Usual Care
Usual care includes completion of a symptom checklist by the nurse practitioner
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed
Tidsramme: at baseline & two weeks after intervention
|
Self reported distress levels at baseline and two weeks after the intervention.
Scale is 11-points from 0(no distress) to 10 (extreme distress)
|
at baseline & two weeks after intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed.
Tidsramme: at baseline & two weeks after intervention
|
Self- report, 24 question scale representing 6 domains related to quality of life.
Quality of life to be measured at baseline and two weeks post intervention.
|
at baseline & two weeks after intervention
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Channing Paller, MD, Johns Hopkins University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- SIB14142
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