Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer
Phase: NA
Conditions: Lung Cancer Stage III, Lung Cancer Stage IV
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
 
Resilience Measurement, Prediction, and its Role in Older Adults with Late-Stage Lung Cancer 
 
Document Date: May 10, 2022 
 
NCT04825912 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
This project will use Self-system therapy (SST), an empirically validated intervention based to treat 
depression and lung-cancer-related distress in older adults (65 years and older). We hypothesize that 
psychological measures and physical performance measures as indicators of resilience will be acceptable 
and feasible to participants. 
 
(Hypothesis 1) Participants will complete at least 80% of SST treatment sessions (Hypothesis 2). There 
will be an association between measures of psychological and physical resilience. (Hypothesis 3). Lastly, 
we hypothesize that participant's psychological and physical resilience scores will improve from baseline 
to post-intervention as a function of receiving the SST intervention. 
 
Background & Significance 
 
Resilience is defined as the capacity of people to effectively cope with, adjust, or recover from stress or 
adversity (physiologically, psychologically or socially). In the context of cancer across the disease 
continuum, resilience refers to an individual’s protective attributes and/or personal characteristics. 
These attributes, which are thought to be modifiable, promote successful adaptation to cancer, 
including, meaning and purpose in life, sense of coherence, positive emotions, self-esteem, self-efficacy, 
cognitive flexibility, coping, and social support. Collectively these factors all positively correlate with 
quality of life, and may enhance physical functioning. Research evidence support findings that suggest 
prolonged stress and poor psychosocial functioning negatively impact physical health. For example, 
prolonged stress influences biological mechanisms that lead to hypertension and blood pressure 
reactivity, pro-inflammatory cytokines (e.g. C reactive protein), and the development of metabolic 
syndrome. 
 
Healthcare providers and healthcare systems benefit from the knowledge and understanding of 
associations between psychological and physical functioning variables that promote resilience in older 
adult patients. These associations inform treatment, prevention, and intervention protocols through a 
biopsychosocial perspective. However, how resilience is studied, measured, and addressed among older 
adults living with serious, life-limiting illness such as advanced lung cancer is an understudied-- yet much 
needed area of research. In addition it is challenging to conceptualize how certain aspects of the 
resilience model apply to more chronic stressors.  
 
Psychological Resilience, as noted above, is one component to enhance an older adult’s quality of life. 
Physical resilience is yet another source to enhance quality of life. Using the NIA’s definition of physical 
resilience as “a dynamic property which enables individuals to resist or recover from the effects of a 
physiological or stressor” (e.g., serious disease such as advanced lung cancer), I want to address in this 
proposal how I can examine the connection between psychological resilience and physical resilience in 
the context of a behavioral intervention to characterize different resilient phenotypes. 
 
With the piloting of SST-LC underway with our study team, for this RCCN proposal I will 1) test measures 
of psychological and physical resilience on an sample of 15 older adults with late-stage lung cancer, and 

2) test whether psychological resilience measures is associated with physical resilience measures in 
efforts to test prediction models in a future larger RCT study.  
 
Design & Procedures 
 
Fifteen older adults (ages 65 and older) will be recruited from clinics of the Duke Cancer Institute. 
 
Older adults with lung cancer will receive the SST intervention with sessions that range between 8 
(recommended minimum number of sessions) to a maximum of 12 sessions lasting on average of 30-45 
minutes. The intervention will be delivered by video conference. The design is a single-arm study, with 
no control or placebo group condition.  
 
The four content/topic areas that are covered across the 8-12 SST intervention sessions are as follows:  
 
1) Orientation Phase of SST. Participants are provided with a rationale for treatment that focuses on the 
importance of self-regulation for well-being in the context of advanced cancer.  
 
2) Exploration Phase of SST. This phase consists of having patients examine successful and unsuccessful 
interpersonal interactions, functional difficulties, and their self-evaluations and goal pursuit strategies 
while coping with advanced cancer. Patients then identify and analyze their explicit or implicit 
preferences for certain kinds of personal goals.  
 
3) Adaptation Phase of SST. The patient and interventionist work together to address each treatment 
goal, using change strategies and compensatory strategies that include helping the patient to modify 
goals or to learn to pursue them via different means that are a better fit to their current life 
circumstances, physical, limitations, or personality traits.  
 
4) A maintenance plan is developed with each patient. The maintenance plan includes a list of strategies 
to be used daily (e.g. self-monitoring forms), short-term goals (e.g. becoming more active in self-
rewarding activities) and long-term goals.  
Selection of Subjects 
  
Patients will be recruited from clinics of the Duke Cancer Institute. Inclusion/Exclusion criteria are listed 
below. These will be determined by medical chart review to ensure that participant involvement is 
appropriate. We are utilizing the duke opt out policy for recruitment purposes. 
 
Inclusion criteria: 
 
Age ≥ 65 years 
English-speaking 
Patient has diagnosis of late stage (III-IV) lung cancer and is living at her/his home. 
 
Exclusion criteria: 
 

Unable to provide informed consent 
Visual or hearing impairments that preclude participation 
Serious mental illness 
 
Subject Recruitment 
 
Potentially eligible candidates will be identified from each oncology provider’s clinic schedules via 
medical chart review. This pre-identification process involves pre-screening of patients using their 
medical records on major characteristics (e.g., disease stage, current treatment status,) to reduce the 
unnecessary burden of contacting patients who will not screen in or of contacting patients who may be 
ill. Study staff will contact providers to obtain approval (as needed) to contact the potential participant. 
If the provider approves, a letter from the patient's provider will be sent to a candidate summarizing the 
research study. We will include a phone number for the patient to call to indicate that she is not 
interested in pursuing the study further.  
 
 A total of 15 patients will be recruited from Duke Cancer Center to complete study procedures. 
 
Participants will have the opportunity to consent electronically via redcap database or by paper over the 
telephone. After completing a baseline assessment, participants will be sent sealed study materials 
along with the instructions regarding the study interventionist's name and contact information. All 
sessions will be conducted by trained interventionists with a Masters or doctoral degree in psychology 
or clinical social work and certified competent in the interventions by the PI. Dr. Ramos will hold regular 
supervision sessions among the interventionists to ensure adequate quality of the delivered 
interventions. All supervision sessions are confidential; no identifiable information about participants is 
retained in supervision records.   
 
Risk/Benefit Assessment 
 
Potential medical risks and discomforts: We do not anticipate any significant medical risks or 
discomforts to lung cancer patients who consent to participate in the study. Should the health status of 
a patient in a way that precludes further study participation, that participant will be able to withdraw 
from the study as needed (which will be stipulated in the consent form as per Duke University policy). 
 
Potential psychological risks and discomforts: The study is not targeting treatment of psychiatric 
illnesses, and we do not anticipate that the participants will be at substantial risk of suicidality, self-
harm, or harm to others. The PI is a licensed clinical psychologist and works in a research lab that has an 
in-place, IRB-approved procedure for the protection of research participants experiencing acute 
increases in distress which will be available throughout the duration of this project. All study staff will be 
trained in this existing procedure (which includes 24-hour phone access to the PI as needed). 
 
A situation in which a study participant is at imminent risk of harming him/herself or others may 
necessitate involuntary reporting and intervention. This risk of loss of confidentiality will be discussed 
and disclosed to potential participants at the time of consenting. Because psychological interventions for 
emotional distress invariably require the patient to attend to discomfort and associated thoughts and 

feeling, participation in the study will be associated with some risk of increased psychological distress, 
which may include discomfort with attention to unpleasant thoughts, feelings, or body sensations. Some 
individuals may experience an initial increase in undesirable feelings with increased attention to them. 
SST already contains procedures for identifying, anticipating, and minimizing discomforts that often 
characterize psychotherapy and related preventive interventions, and the interventionists will be 
thoroughly trained in how to use those techniques to simultaneously protect participants and assist 
them in gaining benefit from the intervention.  
 
There are no known risks related to their administration, although these assessments may uncover 
strong and potentially difficult feelings about the subject’s past or present emotional state. In previous 
studies (spearheaded by co-mentor Dr. Strauman) involving over 1,000 patients, using similar self-report 
batteries, they have encountered little resultant distress. We will, however, train research staff to 
collect data to be sensitive to the nature of illness-related issues. When necessary, participants who 
experience psychological distress related to filling out self-report questionnaires will be referred for 
appropriate psychiatric or psychological care. 
 
Other risks: The other risks of this study are those associated with confidentiality. In any research 
project of this type, there is some risk attendant to confidentiality of self-report data. To ensure 
confidentiality of data, all records will be identified by the participant's identification number, not by 
name. All raw data will be kept in a locked file cabinet. Protocols and completed measures will be coded 
by number only, for the purpose of data tabulation and analysis. Data will be stored in protected 
research computer servers/systems at Duke which employ strict procedures to ensure subject 
confidentiality. All data will be entered into the computer by study staff only, utilizing code numbers 
only for subject identification. All information given by the participants will be kept confidential. There 
will be only one exception to this strict confidentiality policy, which pertains to information obtained 
during the research assessment which would indicate that the participant is seriously suicidal and may 
pose a significant and acute risk of self-harm, or if there is a risk of elder abuse. Subjects will be 
informed of this exception, and will also be informed that such information will be shared with the P.I. 
of the study and their Attending Physician so that timely and appropriate arrangements for psychiatric 
assessment and care can be made. This information is included in the Informed Consent form. 
 
Potential Benefits of the Proposed Research to Human Subjects and Others: 
There are several potential benefits to study participants. First, participants who receive SST may 
experience improvements in quality of life, mental health, physical functioning, and self-efficacy. 
Second, this study will provide data on the feasibility, acceptability of studying measures that capture 
physical and psychological resilience.   
 
This program of research has the potential to meaningfully enhance the mental health, physical 
functioning, and overall well-being of older adults with late-stage lung cancer, change clinical practice, 
and substantively enhance the quality of life of patients. 
 
Importance of the Knowledge to be Gained: 
The risks associated with this study are small compared to the information that will be obtained. The 
information gathered may lead to major advances in our understanding of how to protect the emotional 

health physical health of patients with lung cancer. If successful, it may enlarge our repertoire of 
methods for effectively enhancing the well-being of cancer patients. 
 
Data Analysis & Statistical Considerations 
 
Because this is a small pilot study with a small sample size power calculations are inappropriate. Below is 
a summary of the planned data analysis: 
 
Descriptive statistics will be used to analyze SST-LC attendance, responses to questionnaire items, and 
sociodemographic data. Outcome measure data will be analyzed on an as per protocol basis. 
Standardized mean differences (with Hedges adjustment for small sample size) and 95% confidence 
intervals to examine the relative size of the intervention effect across the different measures. Scores are 
interpreted as positive intervention effects when the post-intervention values of negative affect are 
lower than baseline; and when post-intervention values of efficacy, affect, cognitive appraisal, coping, 
resilience, physical functioning and activity are higher than baseline. Psychological resilience and 
physical resilience self-report scores from baseline to 1-month follow-up will also be analyzed. 
 
All quantitative analyses will be performed using IBM SPSS statistics software. 
 
Participants enrolled in the study will complete participation across 2-4 months.