Telephone Support Program for Lung Cancer Patients and Their Family Caregivers
Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers
1 other identifier
interventional
262
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Mar 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 11, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 10, 2016
March 1, 2016
2.3 years
November 11, 2013
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Patient Health Questionnaire-8
baseline, 2 and 6 weeks post-intervention
Change in Generalized Anxiety Disorder 7-item scale
baseline, 2 and 6 weeks post-intervention
Study Arms (2)
Telephone counseling
EXPERIMENTALTelephone counseling to enhance symptom management and reduce distress
Education
ACTIVE COMPARATOROverview of resources for psychosocial support and health information
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of lung cancer
- Must be able to speak and read English
You may not qualify if:
- No working phone service
- Does not have a family caregiver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Indiana University School of Medicinecollaborator
- American Cancer Society, Inc.collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202, United States
Related Publications (1)
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.
PMID: 29366911DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine E. Mosher, Ph.D.
Indiana University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2013
First Posted
November 25, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 10, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share