Clinical trial NCT02370836: Evaluating the Effects of Psycho-oncological Education on Distress and Quality of Life in Solid Tumor Cancer Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: distress
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distress Thermometer (self-reported distress levels by 11 point scale) Change is being assessed
timeFrame: at baseline & two weeks after intervention
Secondary outcomes:
measure: World Health Organization Quality of Life BREF (WHOQOL-BREF) Change is being assessed.
timeFrame: at baseline & two weeks after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Channing Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: