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

NCT01786187 | Completed Phase 1 Results

• 1 other identifier: R21CA164515
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

Brief 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:

• 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

Lung Cancer

Keywords

Lung Cancer; Symptoms

Outcome Measures

Primary Outcomes (4)

• Determine Feasibility as Measured by Rates of Recruitment.

  Rates of recruitment were measured by the percentage of those eligible who enrolled.

  At the beginning of the study.

• Feasibility as Measured by Adherence.

  Adherence is the percentage of those adhering to the recommended exercise.

  6-weeks.

• Feasibility as Measured by Retention.

  Retention is the percentage of those enrolled and completed and finished the program.

  6-weeks.

• Feasibility as Measured by Adverse Events.

  Adverse Events is the percentage of participant's who had an adverse event.

  6-weeks.

Secondary Outcomes (1)

• Cancer-Related Fatigue Severity

  At six weeks after discharge from the hospital after surgery for lung cancer.

Study Arms (2)

Symptom Experience Group

ACTIVE COMPARATOR

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.

Other: Symptom Experience Report

Light Physical Activity Group

EXPERIMENTAL

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.

Behavioral: Light Physical Activity

Interventions

Light Physical Activity BEHAVIORAL

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.

Light Physical Activity Group

Symptom Experience Report OTHER

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.

Symptom Experience Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men at least 21 years of age with suspected NSCLC to be confirmed after surgery.
• Planned surgical resection, not diagnostics alone, for treatment of suspected non-small cell lung cancer (NSCLC) to include such surgical approaches as open thoracotomy, video assisted thoracic surgery (VATS), and Robotic procedures.
• Karnofsky Performance Status score of at least 70%.
• Thoracic surgeon approval pre- and post-surgery.
• Medically stable co-morbid conditions including cardiovascular disease such as post-myocardial infarction, stable coronary bypass graft surgery, and stable percutaneous transluminal coronary angioplasty; and mild to moderate cardiopulmonary obstructive disease.
• Has phone access capability.
• Able to speak and write English.
• Able to hear and speak for phone interviews.
• Owns a television.
• Lives within 1.5 hours driving distance of recruitment site.

You may not qualify if:

• Severe impairment in seeing, hearing, and speaking.
• Uncontrolled co-morbid conditions such as cardiac or pulmonary disease.
• Uncontrolled hypertension.
• Active treatment for malignancy within the past six months (other than non-melanoma skin cancer and when undergoing long-term hormonal treatment for common cancers such as breast and prostate cancer where disease is stable).
• Presence of metastatic disease.
• Requires portable oxygen therapy for activities of daily living.
• Weight greater than 330 pounds (weight capacity of the Wii balance board).
• History of photosensitive seizures.
• Any condition or disorder that would impede safe participation as directed.
• Plans to relocate outside the study area during the study period or unable to fully participate.
• Diagnosed dementia.
• Video-assisted thoracic surgery (VATS) procedure.

Sponsors & Collaborators

• Michigan State University: lead
• National Cancer Institute (NCI): collaborator
• Corewell Health West: collaborator
• Duke University: collaborator
• Grand Valley State University: collaborator

Study Sites (4)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Sparrow Hospital

East Lansing, Michigan, 48912, United States

Location

West Michigan Cardiothoracic Surgeons

Grand Rapids, Michigan, 49503, United States

Location

McLaren Greater Lansing, Greenlawn Campus

Lansing, Michigan, 48910, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Amy Hoffman, RN, PhD
• Organization: Michigan State University

amy.hoffman@ht.msu.edu

517 355 8348

Study Officials

• Amy J Hoffman, PhD, RN

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: February 7, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 25, 2019
• Results First Posted: February 25, 2019

Record last verified: 2018-09

Locations

US (4)