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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02370836

Enrollment

Registered

2015-02-25

Start date

2015-05-31

Completion date

2015-10-31

Last updated

2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

distress

Brief summary

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

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.

Interventions

OTHEREducation

One 60 minute psycho-oncological educational session on stress management, late effects and fatigue.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026