Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

March 9, 2016 updated by: Indiana University

Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers

The goal of this project is to examine the physical and psychological health benefits of a novel, telephone-delivered symptom management intervention for advanced lung cancer patients and their family caregivers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Hospital
      • Indianapolis, Indiana, United States, 46202
        • Richard L. Roudebush VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of lung cancer
  • Must be able to speak and read English

Exclusion Criteria:

  • No working phone service
  • Does not have a family caregiver

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telephone counseling
Telephone counseling to enhance symptom management and reduce distress
Behavioral: Telephone counseling
Active Comparator: Education
Overview of resources for psychosocial support and health information
Behavioral: Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Patient Health Questionnaire-8
Time Frame: baseline, 2 and 6 weeks post-intervention
baseline, 2 and 6 weeks post-intervention
Change in Generalized Anxiety Disorder 7-item scale
Time Frame: baseline, 2 and 6 weeks post-intervention
baseline, 2 and 6 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Cancer Institute (NCI)
American Cancer Society, Inc.
Indiana University School of Medicine

Investigators

  • Principal Investigator: Catherine E. Mosher, Ph.D., Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K07CA168883-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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