Clinical trial · Interventional
Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners
NCT02596490CI-TRIAL-00108236recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: Our specific aims are to: Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with metastatic lung cancer and their partners. Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and their partners regarding physical, psychological, and spiritual quality of life outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer-Related Discussion Program | Behavioral | — | UNRESOLVED |
| Meditation and Discussion Sessions | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase 1: Couple-Based Mindfulness Disclosure Group
- description
- Phase 1: Couples participate in 2 guided meditation sessions. During the sessions, participants do deep breathing and visualization exercises then asked to review the exercises. Participants also asked for feedback about the instructions. Participants complete a written review about the program and a questionnaire about their general health and well-being. Each session will last about 60-90 minutes.
- interventionNames
- Behavioral: Questionnaires
- Behavioral: Meditation and Discussion Sessions
- type
- EXPERIMENTAL
- label
- Phase 2: Couple-Based Mindfulness Disclosure Group
- description
- Phase 2: Participants complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires. After completing the last session, about 4 weeks later, participants complete the same questionnaires again. Participants also complete a program review. Couples participate in 4 guided meditation sessions with a trained meditation instructor. Participants do deep breathing and visualization exercises. All meditation and discussion sessions videotaped. Participants continue daily meditation practice and some other short exercises at home.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ALL PHASES, PATIENTS ONLY: Diagnosed with stage IV Non-Small Cell Lung Cancer (NSCLC) 2. ALL PHASES, PATIENTS ONLY: Currently receiving treatment (e.g. radiotherapy, chemotherapy) at MD Anderson Cancer Center 3. ALL PHASES, PATIENTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 4. ALL PHASES, PATIENTS ONLY: Have a romantic partner with whom they have resided for a minimum of 6 months 5. ALL PHASES, PATIENTS AND PARTNERS: Must be at least 18 years old 6. ALL PHASES, PATIENTS AND PARTNERS: Able to read and speak English 7. ALL PHASES, PATIENTS AND PARTNERS: Able to provide consent. Exclusion Criteria: 1. ALL PHASES, PATIENTS AND PARTNERS: Not oriented to time, place, or person as deemed by the clinical team 2. ALL PHASES, PATIENTS AND PARTNERS: Regular (self-defined) participation in psychotherapy or a formal cancer support group 3. ALL PHASES, PATIENTS AND PARTNERS: Prior enrollment in a couple-based mind-body intervention research study (protocols 2011-1179, 2013-0496, 2014-0036) conducted by the principal investigator including phase 1 or phase 2 of the current study.
References
Publications (1)
- DERIVEDMilbury K, Tsao AS, Liao Z, Owns A, Engle R, Gonzalez EA, Bruera E, Cohen L. A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners. Pilot Feasibility Stud. 2018 Jan 24;4:37. doi: 10.1186/s40814-018-0231-6. eCollection 2018. PMID 29416870