MIND-WELL Intervention

Browse trials for

• Lung Neoplasms 5,422
• Disease 2,423

Keywords

• post-treatment survivorship
• mindfulness-based stress reduction
• lung cancer
• caregiver
• stress
• healthy lifestyle

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.

Lead sponsor

University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Intervention Group

  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.

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

• No intervention
  Comparison Group

  Participants will receive an educational information packet. A study team member will conduct brief check-in phone calls at weeks 2, 4, and 6.

Interventions

• BehavioralMIND-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.

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 year

2. 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

3. 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

4. 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

5. 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

6. 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

Secondary 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 12

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

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

Individual participant data

Plan to share: No