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

Quality of Life Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370836
• Other study ID #: SIB14142
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: November 17, 2015
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Quality of Life

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No