Meditation for Lung Cancer

Recruiting at 1 trial location

Overseen By Kathrin Milbury, PHD, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Psychotherapy, Cancer support group, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your existing treatments, as the trial is focused on meditation and does not mention medication changes.

What data supports the effectiveness of the treatment Couple-Based Meditation for lung cancer?

Research suggests that mindfulness and self-compassion, which are part of couple-based meditation, may help reduce distress and improve communication in couples facing lung cancer. These skills could positively impact how couples cope with the challenges of cancer. ^{1 2 3 4 5}

Is meditation safe for people with lung cancer?

Research on mindfulness and meditation for lung cancer patients and their partners suggests these practices are generally safe and may help reduce psychological distress. No specific safety concerns have been reported in the studies reviewed. ^{2 4 5 6 7}

How is the Couple-Based Meditation treatment different from other treatments for lung cancer?

Couple-Based Meditation is unique because it focuses on mindfulness and self-compassion skills for both lung cancer patients and their partners, aiming to reduce psychological distress and improve communication within the couple, rather than directly targeting the cancer itself. ^{2 3 4 5 6}

Research Team

Kathrin Milbury, MA,PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients over 18 with stage IV Non-Small Cell Lung Cancer (NSCLC) who are being treated at MD Anderson Cancer Center and have an ECOG status of ≤2. They must live with a romantic partner for at least 6 months. Both patient and partner should speak English, be able to consent, and not participate in regular psychotherapy or cancer support groups.

Inclusion Criteria

ALL PHASES, PATIENTS ONLY: Diagnosed with stage IV Non-Small Cell Lung Cancer (NSCLC)

Patients must have lived with their romantic partner for at least 6 months to be eligible for the study.

ALL PHASES, PATIENTS ONLY: Currently receiving treatment (e.g. radiotherapy, chemotherapy) at MD Anderson Cancer Center

Exclusion Criteria

You regularly participate in therapy or a support group to help you cope with cancer.

ALL PHASES, PATIENTS AND PARTNERS: Not oriented to time, place, or person as deemed by the clinical team

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Couple-Based Mindfulness Disclosure Group

Couples participate in 2 guided meditation sessions involving deep breathing and visualization exercises, followed by feedback and a written review.

2 weeks

2 visits (in-person)

Phase 2: Couple-Based Mindfulness Disclosure Group

Participants complete 12 questionnaires and participate in 4 guided meditation sessions with a trained instructor, including daily meditation practice at home.

4 weeks

4 visits (in-person)

Phase 3: Cancer-Related Discussion Program Group

Participants and partners engage in a discussion program with a trained interventionist, focusing on coping with cancer.

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with questionnaires completed 3 months later.

3 months

Treatment Details

Interventions

• Couple-Based Meditation

Trial Overview The study tests the feasibility of a couple-based meditation program aimed at improving quality of life for metastatic lung cancer patients and their partners. It involves questionnaires, meditation sessions, and discussions about cancer-related topics to assess physical, psychological, and spiritual outcomes.

Participant Groups

Group I: Phase 3: Couple-Based Mindfulness Disclosure Group Experimental Treatment 2 Interventions

Participant completes 13 questionnaires before first mediation session, after last session, and again 3 months later. Questionnaires ask about participant's health, any symptoms they may be having, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. Partners complete 12 questionnaires about their health, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires. Participant and partner attend meditation class with a trained meditation instructor each week for 4 weeks. Each session will last about 60 minutes total. Meditation and discussion sessions videotaped.

Group II: Phase 3: Cancer-Related Discussion Program Group Experimental Treatment 2 Interventions

Participant completes 13 questionnaires before first mediation session, after last session, and again 3 months later. Questionnaires ask about participant's health, any symptoms they may be having, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. Partners complete 12 questionnaires about their health, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires. Participant and partner take part in a discussion program, 1 discussion session each week for 4 weeks with a trained interventionist. These are one-on-one sessions. Issues discussed for couples coping with cancer. Each session will last about 60 minutes.

Group III: Phase 3: Attention Control (AC) Group Experimental Treatment 1 Intervention

Participant completes 13 questionnaires at baseline and again 3 months later. Questionnaires ask about participant's health, any symptoms they may be having, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. Partners complete 12 questionnaires about their health, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. It should take about 45 minutes to complete these questionnaires.

Group IV: Phase 2: Couple-Based Mindfulness Disclosure Group Experimental Treatment 2 Interventions

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.

Group V: Phase 1: Couple-Based Mindfulness Disclosure Group Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

Mindfulness-based interventions (MBIs) have shown significant effectiveness in reducing cancer-related distress and depression among lung cancer survivors and their partners, as evidenced by two randomized controlled trials and several feasibility studies.

The studies indicate that MBIs can improve quality of life, self-compassion, mindfulness skills, and reduce rumination, highlighting the potential benefits of these interventions for both survivors and their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Survivors of Lung Cancer and Their Partners: A Systematic Review. McDonnell, KK., Owens, OL., Umari, F.[2023]

The couple-based mind-body (CBMB) intervention was highly acceptable to patients with metastatic lung cancer and their partners, with all participants recommending it after evaluation sessions.

Preliminary results from a single-arm trial indicated significant improvements in quality of life, including large reductions in sleep disturbances for patients and notable decreases in depressive symptoms for partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Testing of a Brief Couple-Based Mind-Body Intervention for Patients With Metastatic Non-Small Cell Lung Cancer and Their Partners. Milbury, K., Engle, R., Tsao, A., et al.[2021]

The study aims to assess the feasibility of a couple-based mind-body (CBMB) intervention for patients with metastatic non-small cell lung cancer (mNSCLC) and their partners, involving 75 couples randomized into different groups over 4 weeks.

The primary outcome focuses on feasibility metrics, such as consent rates and session attendance, while also exploring self-reported outcomes related to spiritual well-being and psychological distress, which are crucial for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Milbury, K., Tsao, AS., Liao, Z., et al.[2022]

In a study of 88 couples facing lung cancer, both patients and their spouses showed that higher levels of self-compassion were significantly associated with lower psychological distress, indicating that self-compassion may be a key factor in coping with cancer-related stress.

The study suggests that mindfulness and self-compassion not only benefit individuals but may also enhance communication within couples, highlighting the potential for mindfulness-based interventions to improve couple dynamics during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Mindfulness and Self-Compassion Related to Psychological Distress and Communication in Couples Facing Lung Cancer? A Dyadic Approach. Schellekens, MPJ., Karremans, JC., van der Drift, MA., et al.[2020]

A pilot study involving 75 patient-caregiver dyads with metastatic lung cancer showed that couple-based meditation (CBM) delivered via videoconference was feasible and resulted in greater perceived benefits compared to supportive-expressive therapy (SE).

Patients in the CBM group reported significantly lower depressive symptoms and marginally reduced cancer-related stress compared to those receiving usual care, indicating that mindfulness-based interventions may effectively manage psychological symptoms in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Intervention as a Supportive Care Strategy for Patients with Metastatic Non-Small Cell Lung Cancer and Their Spouses: Results of a Three-Arm Pilot Randomized Controlled Trial. Milbury, K., Li, Y., Durrani, S., et al.[2021]

Lung cancer patients who participated in an 8-week mindfulness-based stress reduction (MBSR) program alongside standard care reported significantly lower psychological distress compared to those receiving standard care alone, with a moderate effect size (d = 0.69).

The MBSR intervention also led to improvements in quality of life, mindfulness skills, self-compassion, and reduced rumination in patients, although partners did not show similar benefits, likely due to their focus on the patients' well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial. Schellekens, MPJ., van den Hurk, DGM., Prins, JB., et al.[2022]

This study will evaluate the effectiveness of Mindfulness-Based Stress Reduction (MBSR) in reducing psychological distress in lung cancer patients and their partners, addressing a gap in research since most previous studies focused on breast cancer patients.

The trial will compare MBSR to treatment as usual (TAU) and assess various outcomes, including anxiety, depression, quality of life, and relationship quality, providing valuable insights into the potential benefits of MBSR for this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study. Schellekens, MP., van den Hurk, DG., Prins, JB., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Survivors of Lung Cancer and Their Partners: A Systematic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pilot Testing of a Brief Couple-Based Mind-Body Intervention for Patients With Metastatic Non-Small Cell Lung Cancer and Their Partners. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Are Mindfulness and Self-Compassion Related to Psychological Distress and Communication in Couples Facing Lung Cancer? A Dyadic Approach. [2020]

5. England pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Intervention as a Supportive Care Strategy for Patients with Metastatic Non-Small Cell Lung Cancer and Their Spouses: Results of a Three-Arm Pilot Randomized Controlled Trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study. [2021]