Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

Lung Cancer Clinical Trial

Official title:

Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993550
• Other study ID #: 1K07CA168883-01A1
• Secondary ID: 1K07CA168883-01A
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: March 9, 2016
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Telephone counseling

• Education

Locations

Country	Name	City	State
United States	Eskenazi Hospital	Indianapolis	Indiana
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Richard L. Roudebush VA Medical Center	Indianapolis	Indiana

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire-8		baseline, 2 and 6 weeks post-intervention	No
Primary	Change in Generalized Anxiety Disorder 7-item scale		baseline, 2 and 6 weeks post-intervention	No