Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience

Lung Cancer Clinical Trial

Official title:

Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03724331
• Other study ID #: 0560-18-EP
• Secondary ID: R01CA205025
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. This is a proposed randomized controlled trial of a novel rehabilitative intervention for persons with non-small cell lung cancer after surgery that promotes self-management of cancer-related fatigue (CRF) and is practical, portable, low cost, and safe. The results of the study will provide a novel exercise intervention, and its optimal timing, that helps a vulnerable population by reducing CRF severity and fatigability and is applicable to nearly all post-thoracotomy lung cancer patients.

Description:

Persons with non-small cell lung cancer (NSCLC) report significantly more unmet supportive care needs than other cancer populations, yet they are among the most vulnerable and least studied. Two of the most prevalent unmet supportive care needs include overcoming fatigue and attaining adequate exercise to meet physical demands of daily living. Cancer-related fatigue (CRF) is a prevalent, persistent, and distressing symptom in the NSCLC population. Cancer-related fatigue correlates with greater severity of 15 other symptoms, leading to lower physical function for persons with NSCLC. Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. While surgery is the standard curative treatment for NSCLC, no formal guidelines exist for post-surgical rehabilitation. This is a proposed randomized controlled trial (RCT) of a novel rehabilitative intervention for persons with NSCLC after surgery. The intervention promotes self-management of CRF and tests the intervention's impact on CRF severity and fatigability with analysis by age. Preliminary data included a two-arm RCT (R21 CA164515) incorporating the proposed intervention, where study goals were exceeded for recruitment (66%), retention (97%), adherence (93%), and acceptability. The 6-wk exercise intervention demonstrated preliminary efficacy in significantly reducing CRF severity and fatigability as compared to usual care, with mean CRF levels restored to levels lower than pre-surgery. The exercise group's functional performance exceeded usual care. No adverse events were reported; participants had a mean age of 67 with a mean of 8 comorbid conditions. The investigator's long-term goal is to develop interventions to increase perceived self-efficacy for CRF self-management in order to improve CRF, symptom status, functional status, and quality of life (QOL) for persons with NSCLC. The objective in this application is to determine the efficacy, optimal timing, and sustainability of this innovative home-based exercise intervention. This study has the potential to transform the current standard by providing a rehabilitative exercise intervention after surgery. The intervention is home-based, self-paced, and builds in duration upon discharge from the hospital after surgery. Aim 1: Determine efficacy by comparing the immediate intervention group with wait-list control (usual care) and attention control by age. Aim 2: Determine efficacy of initiating the exercise intervention 6 wks post-discharge and compare results with the immediate intervention group for all ages. Aim 3: Determine the immediate intervention's sustainability by analyzing 3a) rates of extension, adherence, and retention; 3b) acceptability; and 3c) efficacy of primary and secondary outcomes. IMPACT: The results of this study will provide a novel exercise intervention, and its optimal timing, and fill the gap for a vulnerable population by providing a practical, portable, and low-cost means of reducing CRF severity and fatigability that is enjoyable and applicable to nearly all post-thoracotomy lung cancer patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 265
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Fatigue
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Physical Activity
• Quality of Life
• Self Efficacy

Intervention

Behavioral:
• Light Physical Activity 1
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.
• Light Physical Activity 2
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.
• Support Education Activity
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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (4)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI), Spectrum Health Hospitals, The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-Related Fatigue Severity as assessed using an 11-point rating scale	Degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe)	about 6 weeks after discharge from the hospital
Primary	Cancer-Related Fatigue Fatigability as assessed using the 6 minute walk test	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	Other Symptoms Severity	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
Secondary	Perceived Self-Efficacy for Fatigue Self-Management	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
Secondary	Self-Efficacy for Walking Duration	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
Secondary	Activities-Specific Balance Confidence	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
Secondary	Steps Per Day	Performance in average number of walking steps taken per day per week	about 6 weeks after discharge from the hospital
Secondary	Functional Status Performance	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
Secondary	Quality of Life as assessed using a 6-point rating scale	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