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NCT Number: NCT07839325

MIND-WELL Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Non-healthy adults:

  • Inclusion Criteria: 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)
  • Exclusion Criteria: Lung cancer patients who are under 18 years of age or unable to read and speak English will be excluded. Individuals with known 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

Healthy adults:

  • 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

Treatment and study plan

MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions)

Behavioral

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.

Primary outcomes

  1. Recruitment Rate Assessed Using Study Recruitment Records

    Time frame: through study completion, an average of 1.5 year

    Number of participants enrolled divided by the number of eligible participants approached for participation

  2. Retention Rate Assessed Using Study Completion Records

    Time frame: through study completion, an average of 1.5 year

    Number of enrolled participants who completed the study through the final assessment divided by the number enrolled

  3. Intervention Adherence Assessed Using Intervention Tracking Records

    Time frame: through study completion, an average of 1.5 year

    Number/proportion of prescribed intervention activities or sessions completed according to the intervention protocol

  4. Session Attendance Assessed Using Intervention Attendance Logs

    Time frame: through study completion, an average of 1.5 year

    Number and percentage of scheduled intervention sessions attended by each

  5. Participant Satisfaction Assessed by the Client Satisfaction Questionnaire Adapted to Internet-Based Interventions (CSQ-I)

    Time frame: Week 8

    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.

  6. Intervention Acceptability Assessed by Post-Intervention Interview

    Time frame: Week 8

    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.

Secondary outcomes

  1. Dyadic Coping Assessed by the Dyadic Coping Inventory (DCI)

    Time frame: Baseline, Week 8, Week 12

    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.

  2. Perceived Stress Assessed by the Perceived Stress Scale-10 (PSS-10)

    Time frame: Baseline, Week 8, Week 12

    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.

  3. Symptom Burden Assessed by the Edmonton Symptom Assessment System-Revised (ESAS-r)

    Time frame: Baseline, Week 8, Week 12

    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.

  4. Cigarette Smoking Status Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, Week 8, Week 12

    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.

  5. Smokeless Tobacco Use Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, Week 8, and Week 12

    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.

  6. Electronic Cigarette or Vaping Product Use Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, Week 8, and Week 12

    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.

  7. Smoking Cessation Attempt Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, Week 8, and Week 12

    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.

  8. Alcohol Use Frequency Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, Week 8, and Week 12

    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.

  9. Average Number of Alcoholic Drinks Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, Week 8, and Week 12

    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.

  10. Physical Activity Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)

    Time frame: Baseline, Week 8, and Week 12

    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.

  11. Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, Week 8, and Week 12

    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.

  12. Diet Quality Assessed by the Mini-Eating Assessment Tool (Mini-EAT)

    Time frame: Baseline, Week 8, and Week 12

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

MIND-WELL: A Dyadic Intervention for Lung Cancer Survivors and Family Caregivers During Transition

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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