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Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

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ClinicalTrials.gov Identifier: NCT01993550
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : March 10, 2016
Sponsor:
Collaborators:
Indiana University School of Medicine
American Cancer Society, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Indiana University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: Telephone counseling Behavioral: Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers
Study Start Date : March 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in Patient Health Questionnaire-8 [ Time Frame: baseline, 2 and 6 weeks post-intervention ]
  2. Change in Generalized Anxiety Disorder 7-item scale [ Time Frame: baseline, 2 and 6 weeks post-intervention ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993550


Locations
United States, Indiana
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Indiana University School of Medicine
American Cancer Society, Inc.
National Cancer Institute (NCI)
Investigators
Principal Investigator: Catherine E. Mosher, Ph.D. Indiana University School of Medicine

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01993550     History of Changes
Other Study ID Numbers: 1K07CA168883-01A1 ( U.S. NIH Grant/Contract )
1K07CA168883-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Indiana University:
lung cancer
family caregiving
behavioral intervention
counseling
symptom management

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases