psychosocial support for caregiver

Evaluated at baseline, week 1 and week 6 of art therapy

questionnaire administration

quality-of-life assessment

stress management therapy

Kate Kravits, RN, MA

RATIONALE: Art therapy may help relieve emotional distress in caregivers of young patients undergoing bone marrow transplant for cancer.

PURPOSE: This clinical trial is studying art therapy for caregivers of young patients undergoing bone marrow transplant for cancer.

OBJECTIVES:

* Test the effects of an art therapy intervention on emotional distress in caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
* Describe pro-social interactions of caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
* Describe the illness experience of caregivers and how it is impacted by the art therapy intervention.
* Describe the caregivers' current health-related quality of life and life meaning prior to pediatric patients initiation of bone marrow transplantation for cancer.
* Determine the effect size for calculating the sample needed for a randomized clinical trial.

OUTLINE: Caregivers undergo art therapy over 60 minutes once a week for 6 weeks. Each session comprises developing trust through the expression of support, affirmation, and collaboration; creating intimacy through attunement; exploring affective states; integrative processing through the creation of an autobiographical narrative; and identifying opportunities for continued exploration and resources that support the client, should that exploration become necessary.

Caregivers also complete a Meaning of Life Questionnaire and a Family Quality of Life Scale at baseline and at the end of week 6.

Art Therapy for Caregivers of Young Patients Undergoing Bone Marrow Transplant for Cancer

Art Therapy Interventions With Caregivers Supporting Pediatric Patients Who Are Undergoing Bone Marrow Transplantation for Cancer

National Cancer Institute (NCI)

City of Hope Medical Center

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Estrogens

Estrogen Receptor Modulators

Aromatase Inhibitors

Regadenoson

Adenosine

Estrogen Antagonists

Estrogen Receptor Antagonists

Neurotransmitter Agents

Within 2 years of initiating anti-estrogen therapy or 2 years after completing chemotherapy, participants undergo a stress test which consists of receiving adenosine IV over 1-5 minutes or regadenoson IV over 2 minutes and then undergoing CMR imaging over 45-60 minutes at baseline, and again 3-6 months later.

Magnetic Resonance Imaging

Stress Management Therapy

Alexandra Thomas

This pilot trial studies how well a stress test works in detecting heart damage in premenopausal women with stage I-III breast cancer. Giving a stress test with adenosine or regadenoson and cardiovascular magnetic resonance imaging may help doctors detect heart damage caused by breast cancer treatments including chemotherapy and aromatase inhibitors.

PRIMARY OBJECTIVES:

I. To describe decrements in left ventricular myocardial microcirculatory perfusion reserve in premenopausal women treated with an aromatase inhibitor for high-risk hormone receptor-positive breast cancer and in premenopausal women treated without an aromatase inhibitor for triple negative breast cancer over three to six months of in the first 24 months on an aromatase inhibitor or after cessation of chemotherapy, respectively.

SECONDARY OBJECTIVES:

I. To describe changes between the cohorts with hormone receptor-positive and triple negative breast cancer in other measures of cardiovascular function as measured by myocardial rest T1 (myocardial fibrosis burden) and left ventricular ejection fraction (LVEF) measured noninvasively with cardiovascular magnetic resonance (CMR) imaging over three to six months.

II. To describe the relationship of clinical and demographic variables in relation to their potential contribution to changes in left ventricular myocardial microcirculatory perfusion reserve over three to six months in both groups.

III. To study the overall feasibility of accruing and retaining premenopausal women with stage I-III breast cancer in a trial using adenosine stress CMR to assess myocardial perfusion reserve (MPR) and other parameters of cardiovascular health.

OUTLINE:

Within 2 years of initiating anti-estrogen therapy or 2 years after completing chemotherapy, participants undergo a stress test which consists of receiving adenosine intravenously (IV) over 1-5 minutes or regadenoson IV over 2 minutes and then undergoing CMR imaging over 45-60 minutes at baseline and then 3-6 months later.

After completion of study, participants are followed up at 30 days.

Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer

The ESPRIT Study: Estrogen Suppression and Perfusion Reserve With Aromatase-Inhibitor Treatment in Premenopausal Women With Breast Cancer

Will first estimate 95% confidence intervals for each group at each time point as well as for the change from baseline to 3-6-months in each group.

Will be used to correlate myocardial perfusion with T1 and myocardial function (LVEF).

Change in MPRI measures (overall and within each group) will be compared using 2-sample t-tests for binary variables. Correlations will be estimated between BMI and the change in MPRI measures.

Will capture data for those approached and consenting or declining and any reasons given for declining participation into the study. Will be assessed by estimating counts and percent's and corresponding 95% Clopper-Pearson exact binomial confidence intervals. Will be compared to the total number of patients enrolled.

Will be assessed by estimating counts and percent's and corresponding 95% Clopper-Pearson exact binomial confidence intervals. Will be compared to the total number of patients enrolled.

Wake Forest University Health Sciences

Carcinoma

Triple Negative Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients receive biobehavioral stress reduction intervention while on study. Patients undergo blood specimen collection at baseline and follow up and have their medical records reviewed.

Biospecimen Collection

Medical Chart Review

Receive biobehavioral stress reduction intervention

Survey Administration

The Ohio State Comprehensive Cancer Center

Samilia Obeng-Gyasi, MD, MPH

This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.

PRIMARY OBJECTIVES:

I Acceptability of the biobehavioral intervention will be determined using the Client Satisfaction Questionnaire (CSQ). CSQ is an 8-item self-report measure with item assessing different aspects of treatment satisfaction (e.g., quality of service, the degree to which needs were met, overall satisfaction).

III Tolerability of the biobehavioral intervention will be assessed by analyzing pre to post treatment change on the Profile of Mood States.

III Feasibility of the biobehavioral intervention will be assessed using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each BBI session; and, 3) number/percent of patients retained and completing 10 BBI sessions.

SECONDARY OBJECTIVE:

I. To examine the feasibility of collecting biomarkers--white blood cell count, C-reactive protein, Interleukin-6, TNF-alpha (α), systolic blood pressure, diastolic blood pressure, heart rate, total cholesterol, high-density lipoprotein; albumin, hemoglobin A1C, body mass index (BMI).

EXPLORATORY OBJECTIVE:

I. To test for pre/post effects of the biobehavioral stress reduction intervention on measures of stress (Impact of Events Scale), mood and psychological symptoms, and allostatic load.

OUTLINE:

Patients receive biobehavioral stress reduction intervention while on study. Patients undergo blood specimen collection at baseline and follow up, and have their medical records reviewed.

Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer

Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients

Acceptability will be measured at the end of the intervention using the Client Satisfaction Questionnaire (CSQ). CSQ scores range from 8-32 with higher scores indicating higher satisfaction.

This will be assessed analyzing pre to post treatment change on the Profile of Mood States short form. The Profile of Mood States short from is a 37 item survey with lower scores indicative of stable mood.

Feasibility will be evaluated using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each Biobehavioral intervention (BBI) session; and, 3) number/percent of patients retained and completing 10 BBI sessions.

The completeness of the 12 study biomarkers (white blood cell count, C-reactive protein, Interleukin-6, TNF-alpha (α), systolic blood pressure, diastolic blood pressure, heart rate, total cholesterol, high-density lipoprotein; albumin, hemoglobin A1C, body mass index (BMI)) will be assessed pre and post intervention

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Art Therapy for Caregivers of Young Patients Undergoing Bone Marrow Transplant for Cancer	NCT00922285	Health Status U... Psychosocial Ef...	psychosocial su... questionnaire a... quality-of-life... stress manageme...	18 Years -	City of Hope Medical Center
Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer	NCT03505736	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Premenopausal Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag...	Adenosine Magnetic Resona... Regadenoson Stress Manageme...	- 55 Years	Wake Forest University Health Sciences
Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer	NCT05677802	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... HER2-Negative B... Hormone Recepto... Triple-Negative...	Biospecimen Col... Medical Chart R... Stress Manageme... Survey Administ...	18 Years -	Ohio State University Comprehensive Cancer Center
Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer	NCT03505736	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Premenopausal Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag...	Adenosine Magnetic Resona... Regadenoson Stress Manageme...	- 55 Years	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for stress management therapy