Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Cancer Patients

Study Overview
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Brief Summary
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This study evaluates that effects of psycho-oncological education on distress and quality of life in solid tumor cancer patients who have completed chemotherapy with curative intent. Half of the participants will received a psycho-oncological educational intervention while the other half will receive usual care.

Detailed Description
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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.

Official Title
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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.

Conditions
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Quality of Life

Intervention / Treatment
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* Other: Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psycho-oncological education<br>One 60 minute psycho-oncological education session on late effects, fatigue and stress management. | Other: Education<br>* One 60 minute psycho-oncological educational session on stress management, late effects and fatigue.<br>|
| No Intervention: Usual Care<br>Usual care includes completion of a symptom checklist by the nurse practitioner | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distress