MIND-WELL Intervention

NCT07839325 | Not Yet Recruiting

• 1 other identifier: STUDY00007694
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate Assessed Using Study Recruitment Records

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

  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

  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

  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

  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.

  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.

  Week 8

Secondary Outcomes (12)

• Dyadic Coping Assessed by the Dyadic Coping Inventory (DCI)

  Baseline, Week 8, Week 12

• Perceived Stress Assessed by the Perceived Stress Scale-10 (PSS-10)

  Baseline, Week 8, Week 12

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

  Baseline, Week 8, Week 12

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

  Baseline, Week 8, Week 12

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

  Baseline, Week 8, and Week 12

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Healthy adults:

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sumin Park, PhD, RN

CONTACT

520-621-0422; suminp@arizona.edu

Ana Morales

CONTACT

520-621-3825; aam1@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 24, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)