6 sessions of Mindfulness Based Resilience Training

Mindfulness based Resilience Training

Cynthia Stonnington, MD

The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance of a new 6 week intervention in Arizona for our transplant and cancer patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic in Arizona.

Transplant medicine and cancer are major strategic foci of Mayo Clinic. At Mayo Clinic, we are often challenged to respond adequately to the high levels of stress encountered by our transplant patients and their care-givers. The overall aim of this project is to pilot a 6 session intervention in Arizona for our transplant and cancer patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes. Demonstration of a feasible and effective program will allow us to offer similar programs at all three sites. This program has potential to better meet our transplant patients' needs, improve outcomes, and set us apart from other transplant programs who do not offer this intervention for patients and caregivers. Psychiatry already has a good collaboration with transplant medicine, with psychiatry screening transplant patients and following a large subset of patients. Many of the referrals to psychiatry post-transplant have to do with difficulty managing stress or break-down in care-giver support. The proposed program would address this unmet need with a more comprehensive intervention than is currently available at the Mayo Clinic. The role of this pilot program is to:

* Explore the feasibility of routinely offering a resilience intervention involving mindfulness based stress reduction to our solid organ and stem-cell transplant and cancer patients and their care-givers.
* Pilot a mindfulness-based group treatment for stress reduction to assess its impact, using standardized rating tools, on transplant patient stress-levels, sleep quality, anxiety, depression, medical outcomes, and health-care utilization
* Examine patient and care-giver acceptance/adherence and satisfaction
* Understand the resources both in terms of staffing and fees required to offer this as a clinical program in the future
* Explore the reimbursement options for covering the program's expenses.

A Transplant or Cancer Resilience Intervention

A Resilience Intervention Involving Mindfulness Training for Transplant and Cancer Patients and Their Caregivers

Mayo Clinic

Chair, Department of Psychiatry & Psychology

Participants who are categorized as having 'adaptive emotions' and have a non-metastatic disease

Participants who are categorized as having 'adaptive emotions' and have a metastatic disease

Participants who are categorized as having 'maladaptive emotions' and have a non-metastatic disease

Participants who are categorized as having 'maladaptive emotions' and have a metastatic disease

Elise Doppenberg, Msc

Elise Doppenberg-Smit, Msc

Prof. dr. J. Dekker

Prof. dr. A.T.F. Beekman

M.E. van Linde, MD

F. Lamers, PhD

G.E. Doppenberg-Smit, Msc

Elise Doppenberg-Smit

R.H.T. Koornstra, MD, PhD

Elise Doppenberg

H. Pruijt, MD, PhD

R.A.W. Van de Wetering, MD

Prof. dr. H.M.W. Verheul

H.M.W. Verheul, MD, PhD

J.W.B. de Groot, MD, PhD

Primary Objective: To identify indicators distinguishing between adaptive and maladaptive emotions in patients with cancer.

Background of the study:

The occurrence of cancer constitutes a major stressor, leading to a wide range of emotions. Patients need support from relatives, friends and caregivers to deal with these emotions. Some patients need professional mental health care, in addition to support. Unfortunately, an accurate instrument to identify patients in need of professional mental health care is not available. This leads to important mismatches in the provision of care.

In the field of oncology, the concept of 'distress' is used to refer to emotions associated with cancer. Measurement instruments (e.g. Distress Thermometer) are used to identify patients with clinically relevant distress. This approach results in major inconsistencies.While approximately one in three patients scores above the cut-off for distress, only about one in ten patients accepts mental healthcare, while it is unclear how many need mental health care.

In the field of mental health, it is generally acknowledged that a distinction needs to be made between normal and adaptive emotions versus maladaptive and psychopathological emotions in response to a potentially traumatic event such as cancer. The concept of distress fails to make this distinction. Some patients scoring above the cut-off for distress may indeed experience maladaptive emotions. Other patients scoring above the cut-off may actually experience adaptive emotions, which facilitate coping with cancer. Therefore, in order to provide appropriate care, identification of indicators distinguishing between adaptive and maladaptive emotions in patients with cancer is an urgent research priority.

Objective of the study:

To identify indicators that distinguish between adaptive and maladaptive emotions in patients with cancer, derived from recent innovative developments in the field of mental health.

Study design:

Patients are categorized as having 'adaptive emotions' or 'maladaptive emotions', using a reference standard: (a) a diagnostic mental health interview and questionnaires, or (b) patient's subjective need for professional mental health care. In all patients, emotional symptoms, cancer-treatment related symptoms and activities are assessed during a period of two weeks via mobile phone. Assessments of patients takes place twice; at 3 and 6 months after the start of chemo-or immunotherapy.

Adaptive and Maladaptive Emotions in Patients With Cancer: Identification of Indicators

Prompted by Ecological Momentary Assessment (EMA), patients rate the following 15 mood states on a 7-point scale ranging from 1 'not at all' to 7 'very' (in the present study, we use 'emotional symptoms' to refer to these mood states). Emotional symptoms with a negative valence: feeling agitated, upset, irritated, listless/apathetic, down, nervous, bored, anxious, and worried. Emotional symptoms with a positive valence: satisfied, relaxed, cheerful, energetic, enthusiastic and calm. These items have been derived from the The Netherlands Study of Depression and Anxiety (NESDA) EMA diary-protocol, have sufficient with-in person variability and have been extensively used in previous studies.

Prompted by Ecological Momentary Assessment, patients rate the following six symptoms related to cancer-treatment on a 7-point scale ranging from 1 'not at all' to 7 'very': feeling tired, difficulty concentrating, nauseousness, loss of appetite, pain, and shortness of breath. These symptoms have been derived from the European Organisation For Research And Treatment Of Cancer (EORTC) item bank.

Prompted by Ecological Momentary Assessment, patients indicate whether they have been involved in the following five categories of activities: (a) work/study, (b) health-related activities (we will differentiate between activities focused on disease and treatment and activities focused on improving/maintaining physical fitness, and building or maintaining a healthy lifestyle), (c) social activities with relatives or friends, (d) intellectual and religious/spiritual activities, and (e) leisure/pleasure related activities.This question covers activities in the interval since the last assessment. The list of activities corresponds to the list of life goals (see below). Patients indicate in which activities they were involved. Combined with the patient's rating of the personal relevance of life goals (see below), this results in a rating of the involvement in specific activities related to the pursuit of personally relevant life goals.

In a qualitative study prior to this study, we have developed a checklist of potential signs and symptoms (e.g. a specific observation by an oncologist and nurse, such as crying or nervousness) which lead oncologists and nurses to suspect the need for professional mental health care among their patients. This checklist will be filled in by an oncologist and a nurse.

Patients are interviewed about their life goals. In the interview, they are presented with an empirically-derived list of potential life goals, in five categories: (a) achievement or work/study related goals, (b) health-related goals (we will differentiate between goals focused on disease and treatment and goals focused on improving/maintaining physical fitness, and building or maintaining a healthy lifestyle), (c) social goals, (d) psychological goals that focus on inner psychological states, and (e) leisure/pleasure related goals (cheerfulness/fun). Subsequently, patients assess to what extent they are striving to attain these goals, on a 5-point Likert scale raging from 1 'not at all' to 5 'very' (i.e. they rate the personal relevance of these life goals). The scores are used to weigh the five categories of activities (see above).

The Composite International Diagnostic Interview (CIDI) (version 2.1) is a comprehensive, fully-structured interview for the assessment of lifetime and current (1 month recency) mental disorders, used to assess the presence of depression and anxiety disorder. In addition, we use the Four-dimensional symptom questionnaire (4DSQ) (Vier Dimensionele Klachten Lijst (4DKL) to assess adjustment disorder, with patients scoring \> 20 on Distress and without a depressive or anxiety disorder on the CIDI categorized as having an adjustment disorder. The interview is conducted in person by a well-trained researcher. Maladaptive emotions are rated as present if the patient scores positive on major depressive disorder, an anxiety disorder (panic disorder, agoraphobia without panic, specific phobia, social phobia, generalized anxiety disorder, and posttraumatic stress disorder) or adjustment disorder.

The Distress Thermometer is a single item self-report measure of distress. Patients are asked to rate their overall distress on a visual scale from 0 (no distress) to 10 (extreme distress). The Problem List identifies problems in five domains: the practical, social, cognitive-emotional, spiritual/religious and physical domain. Patients indicate whether in the last three months they experienced a problem in these domains, using a five-point scale (ranging from 1 'no problem at all' to 5 'very much a problem'). For every domain in which patients report at least one problem, we ask whether they (a) received a referral for the problem, (b) did not receive a referral, but would have preferred a referral for the problem, (c) did not want or receive a referral for the problem, but would be willing to consider a referral in the future, or (d) did not want or receive a referral, neither in the present nor the future.

The List of Threatening Experiences is a brief life events questionnaire, assessing the occurrence of 12 events (never, past year, life time)

Pittsburgh Sleep Quality Index is a 19 item self-report questionnaire assessing sleep quality and quantity. There are 7 component scores: subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction

Mastery is the feeling to which a person perceives himself or herself to be in control of events and ongoing situations. The 5-item abbreviated mastery scale will be used. A 5-point Likert scale is used to rate each item (e.g. 0 = strongly disagree, 4 = strongly agree).

Participants are asked whether they agree, disagree or are unsure about 3 statements concerning emotional reactivity in daily life (e.g. "Sometimes my feelings are strong, but they don't get in the way of day to day life), and how often (always, often, sometimes, rarely, never) 2 situations concerning emotional reactivity in daily life occur (e.g. How often do you find that your emotions are very unstable, or swing from one extreme to another in a way you sometimes find hard to control?).

The Close Person Inventory is a 14 item self-report questionnaire that will be used to measure social support received from the individual reported as being closest to the participant during the previous 12-month period. A 5-point Likert scale is used to measure how often they experience 3 components of social support: confiding/emotional, practical and negative social support (0 = never, 4 = very often).

Dutch Cancer Society

Amsterdam UMC, location VUmc

Principal Investigator

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Control participants will write about their daily and future tasks three times.

Experimental participants will write about their thoughts and feelings about an emotionally difficult event three times.

Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.

Expressive Writing

Lameese Eldesouky, PhD

James Gross, PhD

The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.

Emotion Regulation and Cancer Caregiving

If data is shared it will only be shared upon request and will be de-identified.

Emotion regulation refers to the ways people influence which emotions they have, and how they experience and express these emotions. Participants will rate their habitual pursuit of pro-hedonic, contra-hedonic, pro-social, and impression management goals using the ERGS. The items will be rated on the same 7-point scale (1 = never; 7 = always).

U.S. National Science Foundation

Stanford University

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Intervention (individualized therapy) plus Standard of Care, and the completion of a psychological questionnaire at chemotherapy start and at the end, approximately four to six months later.

Standard of Care plus the completion of a psychological questionnaire at the beginning of the chemotherapy and at the end, approximately four to six months later.

Participants will receive standard of care plus supportive psychotherapy for a one hour, weekly, during the time they are undergoing neoadjuvant treatments.

Standard of Care + Experimental Individualized Therapy

Participants will undergo standard of care only (no Intervention/no individualized therapy) .

Control: Standard of Care

Luz A. Venta, MD

Pilot study representing a proof of concept regarding the potential for immune system enhancement with psychotherapy, resulting in improved immunological response at lumpectomy or mastectomy in patients undergoing neoadjuvant chemotherapy.

Study participants will receive be randomized to the experimental group (receive individualized psychotherapy + standard of care) or the control group (standard of care) and both groups will complete psychological questionnaires. Both groups will have blood sampling and have their biopsied tissue read for immunological factors.

Patients with triple negative breast cancer or with breast cancers presenting at a large size (greater than one centimeter) have a worst prognosis than other types of breast cancer or cancers that are diagnosed when smaller than one centimeter. For these patients, neoadjuvant chemotherapy, that is chemotherapy given before surgical removal of the cancer, is often used. Common indications for using neoadjuvant therapy include: available clinical trial, learning about the tumor response in vivo to a particular chemotherapy and shrinking the tumor so as to convert a mastectomy to a lumpectomy at the time of resection. In patients receiving neoadjuvant treatment, there is usually 6-months between the diagnosis and the surgical breast tumor resection during which the chemotherapy is administered, and during that time patients are offered support group therapy. Although the prognosis for breast cancer patients has improved, this subset of patients still poses a clinical challenge.

Growing evidence in the psychological field has documented a link between the immune system and psychological factors, emphasizing that stress and trauma are detrimental to the ability and effectiveness of the immune system and emphasizing that mental health has an importance not only in and of itself on how the person feels, but also translates into physical health at least in part through the immune system. Personality traits and other emotional factors remain as viable candidates contributing to the development of malignancies, but the research in this area is confusing. For example, many authors report that depressed women are more prone to develop breast cancer than others, while other research has failed to find such a connection.

Nevertheless, many clinicians notice that cancer tends to present after a major loss or emotional trauma. Some research suggests that the suppression of negative emotions or difficulty expressing emotions such as anger and hostility are characteristic of the cancer-prone personality, so that in a typical study, clinicians who interviewed patients prior to breast biopsy were able to predict the presence of a malignancy in 94% of cases based on psychological factors alone. Similarly, a study has been able to predict with 75% accuracy those patients who had early cancer with no knowledge of their Pap smear results, based on the presence of extreme hopelessness. However, although there are many similar studies, other researchers have not been able to confirm the importance of emotional factors.

Patients will be randomized to two groups.

Emotions Immunology and Breast Cancer

A Pilot Study: Emotions Immunology and Breast Cancer

The self-reported Adverse Childhood Experience Questionnaire measures different types of abuse, neglect, and other hallmarks of a challenging childhood. Scores range from 0-10, with 10 indicating highest childhood abuse \&/or neglect exposure with greater risk for negative consequences later in life, and 0 is lowest exposure and lower risk for negative consequences.questionnaires with immune responses. Pathologic tumor response is our measurable endpoint, focusing on immune cells in the tumor bed at lumpectomy or mastectomy.

The self-reported Depression, Anxiety, and Stress Scale Questionnaire is 3-part tool that measures motional states of depression, anxiety, and stress. Scores range from 0-42 for depression, 0-42 for anxiety and 0-42 for stress. A score closer to 42 for each state is indicative of extremely severe symptoms while a score closer to 0 indicates normal to mild symptom scores.

The self-reported Experiences in Close Relationships-Revised Adult Attachment Questionnaire is a tool that measures how an individual behaves in relationships with others. Scores range from 0-5. A score closer to 0 is indicative of attachment while a score closer to 5 indicates signs of attachment-avoidance.

The self-reported Functional Assessment of Cancer Therapy Questionnaire is a tool that measures how an individual behaves in relationships with others. Scored in a 5 point scale with a total score ranging from 0 to 164, with a higher score indicative of better health related quality of life.

The self-reported Benefit Finding Questionnaire is a tool that measures how an individual might feel their cancer diagnosis contributes to their outlook on life. Scored in a 5 point scale with total scores ranging from 17-85. Higher scores indicate more benefit derived from breast cancer.

The self-reported Acceptance and Action Questionnaire - II is a tool that measures psychological inflexibility and experiential avoidance. Score in a 7 point scale, range 7 to 49. A higher score indicates greater levels of psychological inflexibility .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Transplant or Cancer Resilience Intervention	NCT01629069	Behavior Emotions	Mindfulness bas...	18 Years -	Mayo Clinic
A Transplant or Cancer Resilience Intervention	NCT01629069	Behavior Emotions	Mindfulness bas...	18 Years -	Mayo Clinic
A Transplant or Cancer Resilience Intervention	NCT01629069	Behavior Emotions	Mindfulness bas...	18 Years -	Mayo Clinic
Adaptive and Maladaptive Emotions in Patients With Cancer: Identification of Indicators	NCT05062447	Adaptation, Emo...		18 Years -	Amsterdam UMC, location VUmc
Emotion Regulation and Cancer Caregiving	NCT06123416	Breast Cancer Cancer Healthy Emotions	Expressive Writ...	21 Years -	Stanford University
Emotion Regulation and Cancer Caregiving	NCT06123416	Breast Cancer Cancer Healthy Emotions	Expressive Writ...	21 Years -	Stanford University
Emotions Immunology and Breast Cancer	NCT03609671	Breast Cancer Triple Negative... Emotions Immunology	Standard of Car... Control: Standa...	18 Years -	The Methodist Hospital Research Institute

Spots Global Cancer Trial Database for emotions

Every month we try and update this database with for emotions cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for emotions

Every month we try and update this database with for emotions cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for emotions cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.