Clinical trial NCT03724331: Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
Official title: Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Self Efficacy
Quality of Life
Physical Activity
Lung Cancer
Non-Small Cell Lung Cancer
Keywords: Cancer-Related Fatigue
Fatigue
Symptoms
Functional Status
Quality of Life
Lung Cancer
Rehabilitation
Exercise
Physical Activity
Self-Efficacy
Self-Management
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Spectrum Health Hospitals
name: National Cancer Institute (NCI)
name: The Methodist Hospital Research Institute
First posted: 2018-10-30
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer-Related Fatigue Severity as assessed using an 11-point rating scale
timeFrame: about 6 weeks after discharge from the hospital
measure: Cancer-Related Fatigue Fatigability as assessed using the 6 minute walk test
timeFrame: about 6 weeks after discharge from the hospital
Secondary outcomes:
measure: Other Symptoms Severity
timeFrame: about 6 weeks after discharge from the hospital
measure: Perceived Self-Efficacy for Fatigue Self-Management
timeFrame: about 6 weeks after discharge from the hospital
measure: Self-Efficacy for Walking Duration
timeFrame: about 6 weeks after discharge from the hospital
measure: Activities-Specific Balance Confidence
timeFrame: about 6 weeks after discharge from the hospital
measure: Steps Per Day
timeFrame: about 6 weeks after discharge from the hospital
measure: Functional Status Performance
timeFrame: about 6 weeks after discharge from the hospital
measure: Quality of Life as assessed using a 6-point rating scale
timeFrame: about 6 weeks after discharge from the hospital
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Amy J Hoffman, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: