Fatigue, Self Efficacy, Quality of Life, Physical Activity, Lung Cancer, Non-Small Cell Lung Cancer
Conditions
Keywords
Cancer-Related Fatigue, Fatigue, Symptoms, Functional Status, Quality of Life, Lung Cancer, Rehabilitation, Exercise, Physical Activity, Self-Efficacy, Self-Management
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. A previous study incorporating the proposed intervention exceeded goals for recruitment, retention, adherence, acceptability, and preliminary efficacy, with no adverse events reported. 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.
Interventions
BEHAVIORALLight 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.
BEHAVIORALLight 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.
BEHAVIORALSupport 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.
Sponsors
University of Nebraska
Corewell Health West
National Cancer Institute (NCI)
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-related Fatigue Severity Using The Brief Fatigue Inventory. | about 6 weeks after discharge from the hospital | The Brief Fatigue Inventory measured the degree of cancer-related fatigue severity on an 11-point scale (0-10, 10 = most severe) |
| Cancer-Related Fatigue Fatigability as Assessed Using the 6 Minute Walk Test. | Immediately after discharge from the hospital | This is a times and measured test to determine the number of meters a participant can walk in 6 minutes. Lower values indicate greater fatigability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other Symptoms Severity | about 6 weeks after discharge from the hospital | The MD Anderson Symptom Inventory (MDASI) Severity subscale measures the severity of multiple symptoms in daily life on an 11-point scale (0-10, 10 = most severe). |
| Perceived Self-Efficacy for Fatigue Self-Management | 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) |
| Self-Efficacy for Walking Duration | 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 (0-10; 0 = 0% confident to 10 = 100% confident). No walking periods are actually performed. This measures their confidence in their ability to perform walking for 5 minutes, 10 minutes, 15 minutes etc. up to 60 minutes. Scores are an average across all 12 intervals. Higher scores indicate higher confidence to walk for longer periods. |
| Activities-Specific Balance Confidence | about 6 weeks after discharge from the hospital | A person's perception of balance during every day activities using an 11-point scale (0-10; 0=0% confident, 10 = 100% confident) |
| Steps Per Day | about 6 weeks after discharge from the hospital | Performance in average number of walking steps taken per day per week. Measured by a pedometer. |
| Functional Status Performance | about 6 weeks after discharge from the hospital | SF36 Health \& Well-Being - Physical Component Score. The SF36 measures 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). Items are weighted per developer-provided scalars, averaged, and transformed into a 0-100 scale. In norm-based scoring (provided here), a score of 50 represents the population average, with 10 points representing one standard deviation. Lower scores reflect greater physical limitations and pain, while higher scores indicate better, more functional physical health. |
| Quality of Life as Assessed Using the Quality of Life Index | about 6 weeks after discharge from the hospital | Total scores reported from the Quality of Life Index - CANCER III Versions. Satisfaction with various aspects of life (33 aspects) 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). Total scores are an averaged combination of each aspect's satisfaction and importance using a formula provided by the developer; total scores can range from 0 (very low quality of life) to 30 (very high quality of life). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy J Hoffman, PhD, RN
University of Nebraska
Participant flow
Recruitment details
Prospective participants were contacted in the cardiothoracic surgeon's office and informed about the availability of the study. They were provided with contact information and gave consent to be contacted for enrolling in the study.
Pre-assignment details
Participants went through the consenting process and were given time, if requested, to consider further participation prior to initial assessments.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.7 Years STANDARD_DEVIATION 8.02 |
| Brief Fatigue Inventory | 1.85 Scores on a scale STANDARD_DEVIATION 1.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 221 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 82 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 73 | 0 / 75 |
| other Total, other adverse events | 0 / 87 | 0 / 73 | 0 / 75 |
| serious Total, serious adverse events | 0 / 87 | 0 / 73 | 0 / 75 |
Outcome results
None listed