MIND-WELL Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Lung cancer patients aged 18 years or older who are currently receiving or scheduled to initiate active treatment, including those diagnosed with small cell or non-small cell lung cancer (Stage I-IV)
Disqualifiers
Inclusion Criteria: Family caregivers aged 18 years or older who are providing any type of support (physical, emotional, social, financial) to the lung cancer patients
Exclusion Criteria: Family caregivers who are under 18 years of age or unable to read and speak English will be excluded. Individuals with severe psychiatric illness (e.g., active psychosis or acute psychiatric instability) or severe physical illness that would prevent meaningful participation in the intervention activities, as determined during the eligibility screening process, will be excluded
Trial design
Design model
Parallel
Treatments tested in this trial
MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions)
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Comparison GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 year2
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 year3
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 year4
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 yearSecondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov
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