The Symptom Experience Study in Persons With Non-Small Cell Lung Cancer

NCT01786187 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2019-02-25

Study results available
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Summary

Little is known about the symptom experience of persons having undergone surgery for lung cancer. What we do know is that symptoms are common and can become severe and lasting. The main purpose of this study is two-fold:

1. To better understand the symptom experience of persons with lung cancer prior to surgery and for up to six weeks after returning home from the hospital.
2. To examine the role of a light physical activity program in persons who are undergoing surgery for lung cancer for the treatment of a specific symptom.

The goals of this study include:

* Collecting information about the participant's current and prior health history, symptoms, and health-related quality of life.
* Assessing our ability to recruit participants to the study.
* Assessing participant's level of participation.
* Evaluating the participant's satisfaction with the program.

We expect that patients after undergoing surgery for lung cancer during the recovery process will experience multiple symptoms. We also expect to find that a light intensity physical activity program will be feasible, acceptable, and show a positive impact on symptoms such as cancer-related fatigue and confidence for cancer-related fatigue self-management.

Information gained from this randomized controlled trial study will be used to refine the design of future larger-scale studies targeting symptoms such as cancer-related fatigue for the lung cancer population.

Conditions

Interventions

BEHAVIORAL

Light Physical Activity

Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.

OTHER

Symptom Experience Report

Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Spectrum Health Hospitals

    collaborator OTHER
  • Duke University

    collaborator OTHER
  • Grand Valley State University

    collaborator OTHER
  • Michigan State University

    lead OTHER

Principal Investigators

  • Amy J Hoffman, PhD, RN · Michigan State University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01786187 on ClinicalTrials.gov