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.
Studie Overzicht
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Psycho-oncological education
One 60 minute psycho-oncological education session on late effects, fatigue and stress management.
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One 60 minute psycho-oncological educational session on stress management, late effects and fatigue.
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Geen tussenkomst: Usual Care
Usual care includes completion of a symptom checklist by the nurse practitioner
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed
Tijdsspanne: at baseline & two weeks after intervention
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Self reported distress levels at baseline and two weeks after the intervention.
Scale is 11-points from 0(no distress) to 10 (extreme distress)
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at baseline & two weeks after intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed.
Tijdsspanne: at baseline & two weeks after intervention
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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.
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at baseline & two weeks after intervention
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Channing Paller, MD, Johns Hopkins University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- SIB14142
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