Lung cancer patients often go through more than one type of treatment, such as chemotherapy, radiation, and immunotherapy. These treatments can lead to several transition periods, which may increase stress and leave some needs unmet for patients and their family caregivers. The purpose of this study is to find out whether a program that includes mindfulness (stress reduction) and education is helpful, acceptable, and practical for lung cancer patients and their family caregivers. We also want to learn if this program helps them feel better prepared during these transitions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
The MIND-WELL intervention consists of 6 Zoom sessions over approximately 6-8 weeks with patient-caregiver dyad together. Topics include stress management, physical activity, sleep, nutrition, and communication. Sessions will be led by trained study staff and include mindfulness (stress reduction) practices, educational content, and dyadic activities. The intervention has two components: (1) mindfulness-based stress reduction, and (2) wellness preparation education using the Symptom Management and Survivorship Handbook.
University of Arizona Cancer Center
Tucson, Arizona, United States
Recruitment Rate Assessed Using Study Recruitment Records
Number of participants enrolled divided by the number of eligible participants approached for participation
Time frame: through study completion, an average of 1.5 year
Retention Rate Assessed Using Study Completion Records
Number of enrolled participants who completed the study through the final assessment divided by the number enrolled
Time frame: through study completion, an average of 1.5 year
Intervention Adherence Assessed Using Intervention Tracking Records
Number/proportion of prescribed intervention activities or sessions completed according to the intervention protocol
Time frame: through study completion, an average of 1.5 year
Session Attendance Assessed Using Intervention Attendance Logs
Number and percentage of scheduled intervention sessions attended by each
Time frame: through study completion, an average of 1.5 year
Participant Satisfaction Assessed by the Client Satisfaction Questionnaire Adapted to Internet-Based Interventions (CSQ-I)
Participant satisfaction with the intervention will be assessed using the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I). Scores from all 8 items are summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction with the intervention.
Time frame: Week 8
Intervention Acceptability Assessed by Post-Intervention Interview
Intervention acceptability will be assessed through a semi-structured post-intervention interview exploring participants' experiences with the intervention, including perceived usefulness, satisfaction, and recommendations for improvement.
Time frame: Week 8
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Dyadic Coping Assessed by the Dyadic Coping Inventory (DCI)
The Dyadic Coping Inventory (DCI) is a 37-item measure assessing dyadic coping. Items are rated on a 5-point scale from 1 ("very rarely") to 5 ("very often"). The total DCI score is calculated by summing items 1-35 after reverse-coding negatively keyed items. Items 36 and 37 are evaluation items and are not included in the total score. Total scores range from 35 to 175, with higher scores indicating greater dyadic coping.
Time frame: Baseline, Week 8, Week 12
Perceived Stress Assessed by the Perceived Stress Scale-10 (PSS-10)
The Perceived Stress Scale-10 (PSS-10) is a 10-item measure assessing the degree to which situations in one's life are perceived as stressful. Items are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater perceived stress.
Time frame: Baseline, Week 8, Week 12
Symptom Burden Assessed by the Edmonton Symptom Assessment System-Revised (ESAS-r)
The Edmonton Symptom Assessment System-Revised (ESAS-r) assesses symptom severity using an 11-point numeric rating scale ranging from 0 (no symptom) to 10 (worst possible severity). The total symptom distress score is calculated by summing the six physical symptom items, two emotional symptom items, and the well-being item. Total scores range from 0 to 90, with higher scores indicating greater overall symptom distress. The ESAS-r physical symptom score is calculated by summing six physical symptom items, with total scores ranging from 0 to 60. Higher scores indicate greater physical symptom burden. The ESAS-r emotional symptom score is calculated by summing two emotional symptom items, with total scores ranging from 0 to 20. Higher scores indicate greater emotional symptom burden.
Time frame: Baseline, Week 8, Week 12
Cigarette Smoking Status Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Current cigarette smoking status will be assessed using a question from the Behavioral Risk Factor Surveillance System (BRFSS). Participants will report whether they currently smoke cigarettes every day, some days, or not at all.
Time frame: Baseline, Week 8, Week 12
Smokeless Tobacco Use Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Current smokeless tobacco use will be assessed using a question from the Behavioral Risk Factor Surveillance System (BRFSS). Participants will report whether they currently use chewing tobacco, snuff, or snus every day, some days, or not at all.
Time frame: Baseline, Week 8, and Week 12
Electronic Cigarette or Vaping Product Use Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Electronic cigarette or vaping product use will be assessed using a question from the Behavioral Risk Factor Surveillance System (BRFSS). Participants will report whether they have never used electronic cigarettes or other electronic vaping products, currently use them every day, currently use them some days, or used them in the past but do not currently use them.
Time frame: Baseline, Week 8, and Week 12
Smoking Cessation Attempt Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Among participants who smoke cigarettes, smoking cessation attempts will be assessed using a question from the Behavioral Risk Factor Surveillance System (BRFSS). Participants will report whether, during the past 12 months, they stopped smoking for one day or longer because they were trying to quit smoking.
Time frame: Baseline, Week 8, and Week 12
Alcohol Use Frequency Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Alcohol use frequency will be assessed using a question from the Behavioral Risk Factor Surveillance System (BRFSS). Participants will report the number of days during the past 30 days on which they consumed at least one alcoholic beverage. Values range from 0 to 30 days, with higher values indicating more frequent alcohol consumption.
Time frame: Baseline, Week 8, and Week 12
Average Number of Alcoholic Drinks Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Alcohol consumption will be assessed using a question from the Behavioral Risk Factor Surveillance System (BRFSS). Participants who report alcohol use will report the average number of alcoholic drinks consumed on days when they drank during the past 30 days. Higher values indicate greater average alcohol consumption on drinking days.
Time frame: Baseline, Week 8, and Week 12
Physical Activity Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Physical activity will be assessed using questions from the Behavioral Risk Factor Surveillance System (BRFSS). Participants will report whether they engaged in physical activity or exercise outside of their regular job during the past month, the type of activity performed most frequently, the frequency of that activity per month, and the typical duration of each activity session.
Time frame: Baseline, Week 8, and Week 12
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disturbances over the past month. The PSQI generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, Week 8, and Week 12
Diet Quality Assessed by the Mini-Eating Assessment Tool (Mini-EAT)
The Mini-Eating Assessment Tool (Mini-EAT) is a 9-item questionnaire assessing diet quality. Item scores are summed to produce a total score ranging from 0 to 100, with higher scores indicating healthier dietary patterns. Scores below 61 indicate an unhealthy diet, scores from 61 to 69 indicate an intermediate diet, and scores above 69 indicate a healthy diet.
Time frame: Baseline, Week 8, and Week 12