Skip to main content
OpenTrials
Completed

NCT Number: NCT02370836

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

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

Primary outcomes

  1. Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed

    Time frame: 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 outcomes

  1. World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.