NCT02370836

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable quality-of-life

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

February 3, 2015

Last Update Submit

November 17, 2015

Conditions

Quality of Life

Keywords

distress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    at baseline & two weeks after intervention

Study Arms (2)

Psycho-oncological education

EXPERIMENTAL

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

Other: Education

Usual Care

NO INTERVENTION

Usual care includes completion of a symptom checklist by the nurse practitioner

Interventions

EducationOTHER

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

Psycho-oncological education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-race specific
  • solid tumor cancer patient
  • completed chemotherapy with curative intent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Channing Paller, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 25, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11