Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Quality of Life

Lymphosarcoma

Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.

Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.

Educational Intervention

Meditation Therapy

Questionnaire Administration

Kathrin Milbury

This trial studies how well a mind-body intervention works in improving overall quality of life in adolescents and young adults with lymphoma. A meditation based mind-body intervention may help lower distress, depressive symptoms, and anxiety in adolescents and young adults coping with lymphoma.

PRIMARY OBJECTIVE:

I. Examine the feasibility of the mind-body intervention in adolescents and young adults (AYAs) with lymphoma.

SECONDARY OBJECTIVE:

I. Establish the initial intervention efficacy regarding psychological distress and cancer symptoms (tertiary objective) relative to an attention control (AC) group.

EXPLORATORY OBJECTIVE:

I. Explore mediation (e.g., mindfulness, compassion, social connection, inflammatory processes) and moderation (e.g., demographic and medical factors) of the intervention effects.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks.

GROUP II: Patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks.

After completion of study intervention, patients are followed at 6 and 12 weeks.

Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma

Mind-Body Medicine for Adolescents and Young Adults (AYA) Coping With Lymphoma

We will examine preliminary evidence of intervention efficacy. Meaning and Purpose (1-5) Strongly Disagree 1- Disagree 2, Neither agree or disagree 3, Agree 4, Strongly agree 5.

Day-to-Day Experiences (1-6) Almost Always-1, Very frequently-2, Somewhat Frequently -3, Somewhat Infrequently-4, Very Infrequently-5, Almost Never 6

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Depression

Depressive Disorder

Breast Carcinoma In Situ

Behavioral Symptoms

Carcinoma in Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 2 months.

Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.

Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.

Laboratory Biomarker Analysis

Patricia Ganz

This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of two different types of group interventions (mindfulness and survivorship education), specifically tailored to the needs of younger female breast cancer survivors, in reducing depressive symptoms, compared to a usual care control group.

SECONDARY OBJECTIVES:

I. To compare the efficacy of the two interventions relative to a usual care control group on fatigue, sleep disturbance, and vasomotor symptoms.

II. To examine the efficacy of the two interventions relative to a usual care control group on circulating and genomic markers of inflammation.

III. To explore potential moderators and mediators of intervention efficacy in the two intervention groups.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A (MINDFULNESS AWARENESS PRACTICES \[MAPs\]): Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 3 months.

ARM B (SURVIVORSHIP EDUCATION INTERVENTION \[SE\]): Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living.

ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B.

After completion of study, patients are followed up at 3 and 6 months.

Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)

Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.

Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.

Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.

Moderators will include preparedness for survivorship, intervention preference, and childhood adversity. Will be assessed using condition-by-moderator interaction terms in mixed models.

National Institutes of Health (NIH)

Jonsson Comprehensive Cancer Center

Anxiety Disorders

Mood Disorders

Mental Disorders

Psychotic Disorders

Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.

Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.

Interview

Quality-of-Life Assessment

Supportive Care

Gabriel Lopez

This trial studies how well self-administered meditation therapy works in improving anxiety and depression in cancer patients who exhibit psychosocial distress. Meditation therapy is a mind-body approach that uses a variety of techniques, such as deep breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility of having patients self-administer meditation recordings using a portable, computer-based program during a 2-week period.

SECONDARY OBJECTIVES:

I. Assess the effect of self-administered meditation on anxiety, depression and other symptoms that are part of the Edmonton Symptom Assessment Scale (ESAS) questionnaire.

II. Evaluate participant satisfaction with the meditation delivery and tracking program.

III. Examine the association between the frequency of practice (number of sessions a day) and choice of length of practice (5, 10, or 15 minute sessions) and anxiety, depression and other patient reported outcomes.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (MEDITATION): Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes once daily (QD) for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.

GROUP II (WAITLIST CONTROL): Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.

Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress

Self-Administered Meditation Intervention for Cancer Patients With Psychosocial Distress

Feasibility will be confirmed if at least 50% of the eligible patients approached consent to the study and at least 70% of subjects complete at least two meditation sessions each week during the 2-week period. The study will calculate rates, frequencies, and 90% confidence intervals (CIs) of the rates.

Summary statistics and 90% CIs will be calculated to assess differences in mean anxiety, depression and other outcomes measured at the end of the study, as well as the change scores from baseline, between subjects randomized to meditation and those randomized to wait-list. Additional analysis may include analysis of covariance (ANCOVA) to control for relevant baseline outcome variables or other patient characteristics. Summary statistics and 90% CIs will also be calculated separately by intervention arm and to examine within-subject differences for those who were randomized to wait-list and then received the meditation intervention.

The questionnaire purpose is to learn more about meditation's effect on your health over the past two weeks. It asks, how much do you agree or disagree? Options are, strongly disagree, disagree, neutral, agree and strongly agree. The questionnaire asks patients to pick the closest answer for each statement. The first statements asks, 'My well-being has improved', the second, "I am more focused', the third asks, 'I am in a better mood', the fourth asks, 'My energy level had increased', and lastly, 'I am sleeping better'. The exit questionnaire is scored as a sum value for each scale range provided. For each scale range provided, higher values/and or lower values represent whether participants agree or disagree with the statements listed.

The study will explore the association between frequency of meditation and choice of length of meditation and patient reported outcomes using correlation analyses.

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Respiratory Aspiration

Hypoventilation

Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days.

Participants are instructed on the 3 steps of IK meditation and then perform IK meditation over 15 minutes BID for 28 days.

Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.

Best Practice

Santhosshi Narayanan

This trial studies how well meditative slow breathing or Isha Kriya meditation works in improving cancer-related symptoms in hospitalized participants with cancer. Meditative slow breathing or Isha Kriya meditation may help to decrease perceived stress and enhance well-being in hospitalized cancer participants.

PRIMARY OBJECTIVES:

I. Test the feasibility of the meditation practice.

SECONDARY OBJECTIVES:

I. Explore the acceptability of meditation in cancer patients through modified Global Symptom Evaluation (GSE) and on day 7 +/- 1 day and day 28 +/- 3 days.

II. Explore the effect of meditative practices in cancer patients through Edmonton Symptom Assessment Scale (ESAS) on the day of enrolment and a weekly basis until the end of study at four weeks.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP I (MSB): Participants are instructed on the meditative slow breathing (MSB) technique and then perform MSB over 15 minutes twice daily (BID) for 28 days.

GROUP II (IK MEDITATION): Participants are instructed on the 3 steps of Isha Kriya (IK) meditation and then perform IK meditation over 15 minutes BID for 28 days.

GROUP III (WAITLIST): Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.

Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer

Feasibility Study of Meditative Practices in Hospitalized Cancer Patients

Scale is from 0 to 10 with 0 being no symptoms to 10 being worse symptoms.

Proportions of participants who consider that the study makes their symptoms better estimated along with a 90% confidence interval for each of the intervention groups. The Linear mixed model used to examine the differential changes over time for ESAS scores among the three groups.

Vasodilator Agents

Platelet Aggregation Inhibitors

Urological Agents

Alprostadil

Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks.

Electronic Health Record Review

Medical Device Usage and Evaluation

Survey Administration

Clinical Trials Referral Office

Stacy D. D'Andre, M.D.

This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors.

PRIMARY OBJECTIVES:

I. To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors.

II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support.

III. To measure the impact of interactive meditation and sleep support through MUSE S among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia.

OUTLINE:

Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks.

MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors

Assessed by the number of times participant uses the Muse™ S Headband system and app. Data will be downloaded from the Muse Dashboard to the study team.

Assessed by reviewing usage data and by post-study satisfaction questionnaire adapted from the Was it Worth it Questionnaire (WIWI) asking the patient if the entire research experience, including the intervention, was worth it for them. The WIWI questionnaire includes 3 items: (item 1) Was it worthwhile for you to receive the cancer treatment given in this study? (item 2) If you had to do it over again, would you choose to have this cancer treatment? and (item 3) Would you recommend this cancer treatment to others? Questions are answered with yes, uncertain, or no.

Assessed by a 3-section questionnaire (sleep, quality of life, and anxiety) with a variety of questions answered by multiple choice (e.g., very well, somewhat well, not very well, not well at all) or answered on a scale of 1-10 where 1=as bad as it can band and 10=as good as it can be.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma	NCT04270266	Lymphoma	Educational Int... Meditation Ther... Questionnaire A...	18 Years - 39 Years	M.D. Anderson Cancer Center
Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)	NCT03025139	Cancer Survivor Early-Stage Bre... Stage 0 Breast ... Stage IA Breast... Stage IB Breast... Stage IIA Breas... Stage IIB Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea...	Educational Int... Laboratory Biom... Meditation Ther... Questionnaire A...	- 49 Years	Jonsson Comprehensive Cancer Center
Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress	NCT02988271	Anxiety Depression Malignant Neopl...	Interview Meditation Ther... Quality-of-Life... Supportive Care	18 Years -	M.D. Anderson Cancer Center
Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)	NCT03025139	Cancer Survivor Early-Stage Bre... Stage 0 Breast ... Stage IA Breast... Stage IB Breast... Stage IIA Breas... Stage IIB Breas... Stage IIIA Brea... Stage IIIB Brea... Stage IIIC Brea...	Educational Int... Laboratory Biom... Meditation Ther... Questionnaire A...	- 49 Years	Jonsson Comprehensive Cancer Center
Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer	NCT03445572	Malignant Neopl...	Best Practice Meditation Ther... Meditation Ther... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors	NCT06274034	Breast Carcinom...	Electronic Heal... Medical Device ... Meditation Ther... Survey Administ...	18 Years - 80 Years	Mayo Clinic
Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer	NCT03445572	Malignant Neopl...	Best Practice Meditation Ther... Meditation Ther... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center

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