Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

This study has been completed.
Sponsor:
Collaborators:
Indiana University School of Medicine
American Cancer Society, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01993550
First received: November 11, 2013
Last updated: March 9, 2016
Last verified: March 2016
  Purpose
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 Intervention
Lung Cancer
Behavioral: Telephone counseling
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change in Patient Health Questionnaire-8 [ Time Frame: baseline, 2 and 6 weeks post-intervention ] [ Designated as safety issue: No ]
  • Change in Generalized Anxiety Disorder 7-item scale [ Time Frame: baseline, 2 and 6 weeks post-intervention ] [ Designated as safety issue: No ]

Enrollment: 262
Study Start Date: March 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01993550     History of Changes
Other Study ID Numbers: 1K07CA168883-01A1 
Study First Received: November 11, 2013
Last Updated: March 9, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 09, 2016