Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

MCG-BCS manual outlines 8 approximately, 90-minute modules: 1) Concepts \& Sources of Meaning; 2) Identity, Cancer Survivorship, \& Meaning; 3) Historical Sources of Meaning: Past Legacy; 4) Historical Sources of Meaning: Present \& Future Legacy; 5) Attitudinal Sources of Meaning: Encountering Life's Limitations; 6) Creative Sources of Meaning: Creativity \& Responsibility; 7) Experiential Sources of Meaning: Connecting with Life via Love, Beauty, \& Humor; and 8) Transitions: Reflections \& Hopes for the Future.

manualized group intervention

DG is a standardized, manualized group developed by the MSKCC Psychiatry Service and utilized in a similar form in our completed and ongoing RCTs of MCGP. Based on models described by Rogers and Bloch, the essential components include reassurance, explanation, education, encouragement, and permission for expression. The process emphasizes Rogerian concepts (e.g., empathic understanding) and avoids techniques that are not exclusively supportive. The content focuses on education about here-and-now topics relevant to BCS (e.g., maintaining and eliciting social support, financial strains, return to work, physical symptom management), allowing emotional expression and discussion of difficult topics.

standardized, manualized group intervention

Monique James, MD

The purpose of this study is to compare two types of groups for breast cancer survivors: a Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to deal with the emotional burden of having gone through the cancer experience. Participation in groups offering support often helps cancer survivors cope with stressors of life after having had cancer by giving them a place to express their feelings. The "Meaning-Centered Group" is intended to teach breast cancer survivors how to maintain or even increase a sense of meaning and purpose in their lives after treatment for cancer. The "Discussion Group" is intended to help breast cancer survivors cope by giving them a place to get support from other breast cancer survivors.

The goal of this study is to compare the benefits of these two types of group approaches for breast cancer survivors. The study is also testing the benefits and feasibility of conducting the groups virtually using a telephone and computer.

Group Interventions for Breast Cancer Survivors

Development of Group Interventions for Breast Cancer Survivors

American Cancer Society, Inc.

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Death

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group.

Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group.

The intervention is a series of 3 guided discussions (using visual aids) between the child's primary oncology physician/nurse team and the child's parent(s) with the purpose of improving parental comprehension of the options for goals of treatment, along with the benefits and burdens of each option.

Novel Communication Intervention

The Enhanced Usual Care Parent Education is a series of 3 discussions between the child's primary oncology nurse and the child's parent(s) designed to control for time and attention. These discussions are focused on answering parents' questions and reviewing routine disease and treatment related information. Parents will receive a 1-hour face-to-face session every 3-4 months for a total of 3 sessions. At each session, parents choose 2-3 topics to review with the nurse.

Enhanced Usual Care Parent Education

Susan M Perkins, PhD

Karen Moody, MD

Project Manager

Site Investigator

Program Manager

This prospective cluster-randomized trial examines the efficacy of a novel communication intervention delivered by trained physician and nurse dyads to parents of children with cancer within the clinicians' practice, to foster alignment of the goals of treatment. The investigators hypothesize that goal alignment will improve quality of life outcomes, in particular for those patients who reach end of life. Findings from the proposed research will provide essential information to promote communication practice standards that can be rapidly translated into practice to improve outcomes for children, particularly those who reach end of life, and parents.

The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.

This is a multi-site, 2-group, cluster-randomized controlled trial, with clusters randomized by pediatric oncology physician-nurse dyads.

A trained blinded evaluator will meet with participants to complete baseline and subsequent follow-up measures, including end-of-study chart review data. Physician-nurse dyads for each arm are trained differently and naive to alternate study arm.

Informational Meetings for Planning and Coordinating Treatment

We will compare days enrolled in hospice between the Novel Communication Intervention vs Enhanced Usual Care Parent Education groups using a Wilcoxon Rank Sum Test for clustered data.

High intensity medical interventions include: code status order to attempt cardiopulmonary resuscitation, intensive care unit admission within the last 30 days, IV chemotherapy within last 14 days, greater than 2 emergency department visits within last 30 days, more than 1 hospitalization within last 30 days, not on hospice, admitted to hospice less than 3 days prior to death, intubation or cardiac resuscitation within last 30 days, and death in an acute care setting.

The difference in the use of high-intensity medical interventions at end of life will be tested between the intervention and enhanced usual care groups with a generalized linear mixed model that accounts for subjects clustering within physician/nurse teams via a random effect.

Quality of Life is measured with the Pediatric Quality of Life Inventory- General Module, emotional functioning sub-scale and the Pediatric Quality of Life Cancer Module. Scores range from 0-100, with higher scores indicating better health-related quality of life. Results will be modeled with linear mixed models and compared between the Novel Communication Intervention and Enhanced Usual Care Parent Education groups.

The Herth Hope Index score ranges from 12-48, with a higher score corresponding to higher levels of hope. Results from the Herth Hope Index are continuous and will be modeled with linear mixed models and compared between the intervention and enhanced usual care groups.

The Parent Experience of Childhood Illness Scale (PECI)-Short Form is used to assess parental adjustment in the primary caregiver of children with chronic illness. It consists of four sub-scales with scores ranging from 0-4. Higher scores indicate poorer coping except for emotional resources, which indicates a higher level of support.

The Peds QL HCS (Satisfaction with Healthcare) survey is 24-item scale that measures parent satisfaction with care received from their child's oncology healthcare providers. Subscales assess parental satisfaction with:

1. delivery of care;
2. information received on child's diagnosis and treatments;
3. inclusion of family;
4. technical skills in managing their child's symptoms; and
5. attention to their child's emotional needs.

National Cancer Institute (NCI)

Indiana University

Professor of Biostatistics and Health Data Science

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Multi-center, open-label, single-arm, phase I/II clinical trial

Interventions

This is a phase II trial designed to test the safety and efficacy (complete response \[CR\]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML).

Patients with newly diagnosed AML who failed to achieve a complete remission (CR) after one or two standard induction attempts receive after a preparative regimen of cyclophosphamide and fludarabine a single infusion of CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.

This trial uses a Simon's two-stage design to estimate the complete remission rate at day +42 post NK cell infusion. The trial includes an initial randomized sub- study of 24 patients during stage 1 to choose which of the enriched NK cell products (CD3-/CD19- versus CD3-/CD56+) should be used to complete the trial based on successful in vivo NK cell expansion. This parameter is defined as 40% donor DNA and 40% of lymphocytes are NK cells at day 7 post infusion OR 20% donor DNA and 20% of lymphocytes are NK cells at day 14 post infusion. Twelve patients will be randomized to each product.

Enrollment Plan:

Stage 1: Enroll 24 patients with 1:1 randomization for NK cell processing (CD3-/CD19- versus CD3-/CD56+) Stage 2: Enroll an additional 17 patients using the optimal NK cell product identified during stage 1.

If neither product achieves success at the end of stage 1, the study will stop and the platform redesigned

In summary, the study will take place in two parts:

Stage 1: Enroll 24 patients with 1:1 randomization for NK cell processing (CD3-/CD19- versus CD3-/CD56+) Stage 2: Enroll an additional 17 patients using the optimal NK cell product identified during stage 1.

If neither product achieves success at the end of stage 1, the study will stop and the platform redesigned

CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR

A Randomized Trial Comparing CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for Adults With Acute Myelogenous Leukemia Who Have Failed 1 or 2 Induction Attempts

Both the number of patients with leukemia in complete remission and the number of patients with leukemia not in complete remission will be reported. Leukemia remission status will be assessed according to the Revised Recommendations of The International Working Group (J Clin Oncol 21:4642-4649, 2003).

Successful expansion and persistence of NK cells is defined as ≥ 100 donor derived NK cells per µl blood.

Masonic Cancer Center, University of Minnesota

University of Chicago

Ohio State University

Miltenyi Biotec B.V. & Co. KG

No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.

After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).

CD3-/CD19- NK Cells Followed by IL-2

After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).

CD3-/CD56+ NK Cells Followed by IL-2

Total

Participant age (years)

Age, Customized

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

No participants were enrolled on the CD3-/CD19- NK cells arm. The study was closed due to poor enrollment.

As a result of poor subject accrual (n=1), statistically relevant efficacy data cannot be defined according to the protocol.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Group Interventions for Breast Cancer Survivors	NCT01775085	Breast Cancer S...	manualized grou... standardized, m...	18 Years -	Memorial Sloan Kettering Cancer Center
Informational Meetings for Planning and Coordinating Treatment	NCT04330833	End of Life Communication Cancer Metastat...	Novel Communica... Enhanced Usual ...	1 Month - 17 Years	Indiana University
CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR	NCT03152526	Acute Myelogeno...	Interventions	18 Years - 75 Years	Miltenyi Biomedicine GmbH
Group Interventions for Breast Cancer Survivors	NCT01775085	Breast Cancer S...	manualized grou... standardized, m...	18 Years -	Memorial Sloan Kettering Cancer Center
CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR	NCT03152526	Acute Myelogeno...	Interventions	18 Years - 75 Years	Miltenyi Biomedicine GmbH

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