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Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone counseling
Education
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring lung cancer, family caregiving, behavioral intervention, counseling, symptom management

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eskenazi Hospital
  • Indiana University Simon Cancer Center
  • Richard L. Roudebush VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telephone counseling

Education

Arm Description

Telephone counseling to enhance symptom management and reduce distress

Overview of resources for psychosocial support and health information

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-8
Change in Generalized Anxiety Disorder 7-item scale

Secondary Outcome Measures

Full Information

First Posted
November 11, 2013
Last Updated
March 9, 2016
Sponsor
Indiana University
Collaborators
Indiana University School of Medicine, American Cancer Society, Inc., National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01993550
Brief Title
Telephone Support Program for Lung Cancer Patients and Their Family Caregivers
Official Title
Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
Indiana University School of Medicine, American Cancer Society, Inc., National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, family caregiving, behavioral intervention, counseling, symptom management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone counseling
Arm Type
Experimental
Arm Description
Telephone counseling to enhance symptom management and reduce distress
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Overview of resources for psychosocial support and health information
Intervention Type
Behavioral
Intervention Name(s)
Telephone counseling
Intervention Type
Behavioral
Intervention Name(s)
Education
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-8
Time Frame
baseline, 2 and 6 weeks post-intervention
Title
Change in Generalized Anxiety Disorder 7-item scale
Time Frame
baseline, 2 and 6 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine E. Mosher, Ph.D.
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29366911
Citation
Winger JG, Rand KL, Hanna N, Jalal SI, Einhorn LH, Birdas TJ, Ceppa DP, Kesler KA, Champion VL, Mosher CE. Coping Skills Practice and Symptom Change: A Secondary Analysis of a Pilot Telephone Symptom Management Intervention for Lung Cancer Patients and Their Family Caregivers. J Pain Symptom Manage. 2018 May;55(5):1341-1349.e4. doi: 10.1016/j.jpainsymman.2018.01.005. Epub 2018 Jan 31.
Results Reference
derived

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Telephone Support Program for Lung Cancer Patients and Their Family Caregivers

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