- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724331
Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amy J Hoffman, PhD, RN
- Phone Number: 5163843685 616-826-7820
- Email: amyj.hoffman@unmc.edu
Study Contact Backup
- Name: Karin Trujillo, MD
- Phone Number: 516-384-3685
- Email: ktrujillo@unmc.edu
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Karin Trujillo, MD
- Phone Number: 516-384-3685
- Email: ktrujillo@unmc.edu
-
Contact:
- Amy J Hoffman, PhD
- Phone Number: 402-559-2208
- Email: amyj.hoffman@unmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women and men
- At least 18 years of age (Michigan) and 19 years of age in (Nebraska)
- With suspected non-small cell lung cancer to be confirmed after surgery
- Karnofsky Performance Status score of at least 70%
- Thoracic surgeon approval pre- and post-surgery
- Medically stable comorbid conditions allowing for non-small cell lung cancer surgery clearance
- Has phone access capability
- Able to speak and write English
- Able to hear and speak for phone interviews
- Owns a television
- Lives within 2 hours driving distance of recruitment site
Exclusion Criteria:
- Severe impairment of sight, hearing, speaking
- Active treatment for malignancy within past 3 months (other than non-melanoma skin cancer or long-term hormonal treatment for common cancers such as breast and prostate if disease is stable
- Weight greater than 330 pounds
- History of photosensitive seizures
- Any condition or disorder that would impede safe participation as directed
- Plans to relocate outside the area during the study period or unable to fully participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Light Physical Activity 1
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital.
|
Light (mild) physical activity program that corresponds with normal every day activities of daily living (< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher. The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital. |
Experimental: Light Physical Activity 2
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light (mild) physical activity program that begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital.
|
Light (mild) physical activity program that corresponds with normal every day activities of daily living (< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher. The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital. |
Active Comparator: Support Education Activity
Conventional treatment for cancer as prescribed by the participant's health care providers and will participate in a supportive cancer-related education activity each week for 6-weeks after returning home from the hospital.
|
Participate in a supportive cancer-related education activity including a direct 10 - 15 minute phone conversation with a Registered Nurse researcher each week for 6-weeks after returning home from the hospital. Wear a pedometer each day of the study. Recording pedometer steps in the daily diary each day. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer-Related Fatigue Severity as assessed using an 11-point rating scale
Time Frame: about 6 weeks after discharge from the hospital
|
Degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)
|
about 6 weeks after discharge from the hospital
|
Cancer-Related Fatigue Fatigability as assessed using the 6 minute walk test
Time Frame: about 6 weeks after discharge from the hospital
|
Average fatigue level while performing the 6 minute walk test on an 11-point scale (0-10, 10 = most severe)
|
about 6 weeks after discharge from the hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other Symptoms Severity
Time Frame: about 6 weeks after discharge from the hospital
|
Severity of multiple symptoms and symptoms interference on daily life on an 11-point scale (0-10, 10 = most severe and most interference)
|
about 6 weeks after discharge from the hospital
|
Perceived Self-Efficacy for Fatigue Self-Management
Time Frame: about 6 weeks after discharge from the hospital
|
A persons's perception of ability to manage fatigue on an 11-point scale (0-10, 10 = very certain)
|
about 6 weeks after discharge from the hospital
|
Self-Efficacy for Walking Duration
Time Frame: about 6 weeks after discharge from the hospital
|
A person's perception to complete incremental 5-minute periods of walking using an 11-point scale (0-100%, 100% = very confident)
|
about 6 weeks after discharge from the hospital
|
Activities-Specific Balance Confidence
Time Frame: about 6 weeks after discharge from the hospital
|
A person's perception of balance during every day activities using an 11-point scale (0-100%, 100% = very confident
|
about 6 weeks after discharge from the hospital
|
Steps Per Day
Time Frame: about 6 weeks after discharge from the hospital
|
Performance in average number of walking steps taken per day per week
|
about 6 weeks after discharge from the hospital
|
Functional Status Performance
Time Frame: about 6 weeks after discharge from the hospital
|
Performance of daily mental and physical activities that people do in the normal course of their lives measured with eight subscales that focus on the physical and mental health components producing normative scores (0-100, 100 = higher functional status)
|
about 6 weeks after discharge from the hospital
|
Quality of Life as assessed using a 6-point rating scale
Time Frame: about 6 weeks after discharge from the hospital
|
Satisfaction with various aspects of life and the importance of each aspect of life to the person using a 6 point-rating scale (1-6, 6 = very satisfied and very important)
|
about 6 weeks after discharge from the hospital
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy J Hoffman, PhD, RN, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0560-18-EP
- R01CA205025 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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