NCT01993550

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

November 11, 2013

Last Update Submit

March 9, 2016

Conditions

Keywords

lung cancerfamily caregivingbehavioral interventioncounselingsymptom management

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

EXPERIMENTAL

Telephone counseling to enhance symptom management and reduce distress

Behavioral: Telephone counseling

Education

ACTIVE COMPARATOR

Overview of resources for psychosocial support and health information

Behavioral: Education

Interventions

Telephone counseling
EducationBEHAVIORAL
Education

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (3)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

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.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Catherine E. Mosher, Ph.D.

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

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

Locations