Lung Cancer (Diagnosis)NCT07839325
MIND-WELL Intervention
A study testing MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions) in people with Lung Cancer (Diagnosis) and Caregiver, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (Diagnosis), Caregiver, Stress
- What is being tested?
- MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85719
Robyn Bullock-Hale, PhD, RN, 317-670-9812, Robyn.BullockHale@bannerhealth.com
About this study
Official title: MIND-WELL: A Dyadic Intervention for Lung Cancer Survivors and Family Caregivers During Transition
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.
- Conditions
- Lung Cancer (Diagnosis), Caregiver, Stress
- Being tested
- MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions)
- Keywords
- post-treatment survivorship, mindfulness-based stress reduction, lung cancer, caregiver, stress, healthy lifestyle
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants (patient-caregiver dyad together) will take part in 6 Zoom sessions over approximately 6-8 weeks. Each session will last up to 1 hour and will be scheduled at a convenient time. Sessions will be led by trained study staff and include mindfulness (stress reduction) practices, educational content, and dyadic activities. Topics include stress management, physical activity, sleep, nutrition, and communication. The intervention has two components: (1) mindfulness-based stress reduction, and (2) wellness preparation education using the Symptom Management and Survivorship Handbook. Receives: Behavioral: MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions) |
| Comparison Group | No intervention | Participants will receive an educational information packet. A study team member will conduct brief check-in phone calls at weeks 2, 4, and 6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate Assessed Using Study Recruitment Records
Number of participants enrolled divided by the number of eligible participants approached for participation
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 8
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839325
- Sponsor's protocol ID
- STUDY00007694
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND-WELL: A Dyadic Intervention for Lung Cancer Survivors and Family Caregivers During Transition
- ClinicalTrials.gov ID
- NCT07839325
- Acronym / sponsor ID
- STUDY00007694
- Conditions
- Lung Cancer (Diagnosis), Caregiver, Stress
- Keywords
- post-treatment survivorship, mindfulness-based stress reduction, lung cancer, caregiver, stress, healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions)Participants (patient-caregiver dyad together) will take part in 6 Zoom sessions over approximately 6-8 weeks. Each session will last up to 1 hour and will be scheduled at a convenient time. Sessions will be led by trained study staff and include mindfulness (stress reduction) practices, educational content, and dyadic activities. Topics include stress management, physical activity, sleep, nutrition, and communication. The intervention has two components: (1) mindfulness-based stress reduction, and (2) wellness preparation education using the Symptom Management and Survivorship Handbook. |
| Comparison Group | No intervention | –Participants will receive an educational information packet. A study team member will conduct brief check-in phone calls at weeks 2, 4, and 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions)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. | Behavioural | Intervention Group |
Primary outcome
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
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
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
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
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.
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.
12 secondary outcomes
Dyadic Coping Assessed by the Dyadic Coping Inventory (DCI)
Time frame: Baseline, Week 8, Week 12
Perceived Stress Assessed by the Perceived Stress Scale-10 (PSS-10)
Time frame: Baseline, Week 8, Week 12
Symptom Burden Assessed by the Edmonton Symptom Assessment System-Revised (ESAS-r)
Time frame: Baseline, Week 8, Week 12
Cigarette Smoking Status Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: Baseline, Week 8, Week 12
Smokeless Tobacco 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 Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: Baseline, Week 8, and Week 12
Smoking Cessation Attempt Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: Baseline, Week 8, and Week 12
Alcohol Use Frequency Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: Baseline, Week 8, and Week 12
Average Number of Alcoholic Drinks Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: Baseline, Week 8, and Week 12
Physical Activity Assessed Using Questions From the Behavioral Risk Factor Surveillance System (BRFSS)
Time frame: Baseline, Week 8, and Week 12
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 8, and Week 12
Diet Quality Assessed by the Mini-Eating Assessment Tool (Mini-EAT)
Time frame: Baseline, Week 8, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND-WELL Intervention (MINDfulness-based Intervention for Navigation of Dyadic WELLness and Education During Transitions) in people with Lung Cancer (Diagnosis) and Caregiver, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumin Park, PhD, RN (520-621-0422, suminp@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate Assessed Using Study Recruitment Records (time frame: through study completion, an average of 1.5 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.