Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent
* Palliative Care Intervention
* Therapeutic Relationship

  --Develop a strong therapeutic relationship with patients and caregivers
* Assessment and Treatment of Patient Symptoms

  --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms
* Managing Patients and Caregivers Expectations

  --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects
* Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support)

* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent.
* Standard Transplant Care

team of clinicians that specialize in the lessening (palliation) of many distressing symptoms

Palliative Care Intervention

Standard Transplant Care

Areej El-Jawahri, MD

This research study is evaluating the impact of early involvement of a palliative care team working with the transplant oncology team will have on the quality of life, symptoms, and mood of patients undergoing stem cell transplantation.

The Participant has a type of blood cancer and will be undergoing stem cell transplantation. Frequently people undergoing stem cell transplantation experience physical and emotional symptoms during the course of their hospitalization for stem cell transplantation. These can be very distressing to both patient and the family members. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms may improve the participant overall care.

This team of clinicians is called the palliative care team and they focus on ways to improve the participant pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's family in coping with the emotional and social issues associated with your diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness.

The main purpose of this study is to compare two types of care - standard transplant oncology care and standard transplant oncology care with early involvement of palliative care clinicians to see which is better for improving the experience of patients and families with blood cancers undergoing stem cell transplantation.

The purpose of this research study is to find out whether introducing patients and families undergoing stem cell transplantation to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during hospitalization for stem cell transplantation.

The study will use a series of questionnaires to measure the participant and the participant 's caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as need.

Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

Multi-Site Randomized Trial of Inpatient Palliative Care for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

Compare patient coping using the Brief Cope questionnaire between the study groups We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.

compare caregiver coping (Brief Cope) between the study groups. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.

mediation analysis (mediation analyses are common in these types of studies, there is no novel new outcome measure here, but rather examining mediation)

moderation analysis (moderation analyses are common in these types of studies. there is no new novel outcome measure here, bur rather examining moderation)

Compare patient QOL using the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scores at week 2 between the study groups Score range 0-164 with higher score indicating better quality of life

Compare patients' QOL using Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) longitudinally between the study groups Score range 0-164, with higher score indicating better quality of life

Compare patients' symptoms using the revised Edmonton Symptom Assessment Scale (ESAS) scores between the study groups score range 0-100 with higher score indicating worse symptom burden

Compare patients' fatigue using Functional Assessment of Cancer Therapy- Fatigue (FACT-fatigue) scores between the study groups score range from 0-52 with higher scores indicating lower fatigue symptoms

Compare patients' depression and anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS) between the study groups The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)

Compare patients' depression using Patient-Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27, with higher score indicative more depressive symptoms

Compare patients' post-traumatic stress symptoms using the PTSD Checklist- Civilian version (PCL-C) between the study groups PCL-C score ranges from 17-85 with higher scores indicating worse PTSD symptoms

Compare caregivers' QOL using caregiver oncology QOL questionnaire (CARGOQOL) scores between the study groups the caregiver oncology QOL questionnaire ranges from 0-116 with higher scores indicating better caregiver QOL.

Compare caregivers' psychological distress using hospital anxiety and depression scale (HADS) between the study groups the HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)

Compare caregivers' depression symptoms using the Patient Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27 with higher scores indicating worse depression symptoms.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

Given that this is a supportive care study, the protocol a priori specified that only averse events that are related to the study intervention or treatment would be reported. This is standard for supportive care trial in high-risk population where outcomes such as hospitalization/death are expected, but are not related to the study. That is how adverse events were defined and reported in this trial.

* Patients will complete baseline self-report assessments at the time of obtaining informed consent
* Patients will receive the palliative care intervention, which entails having twice weekly visits during the transplant hospitalization.

Inpatient Palliative Care Intervention Patient

* Patients will complete baseline self-report assessments at the time of obtaining informed consent.
* Standard Transplant Care

Standard Transplant Care: Standard care per hospital guidelines

Transplant Care Alone Patient

- Patients who enroll in the study may identify a caregiver to participate in the trial. The caregiver will follow the randomization of the patient. Caregivers of patients randomized to the palliative care intervention may meet with the palliative care clinicians during the patient's hospitalization for stem cell transplantation

Inpatient Palliative Care Intervention Caregiver

-patients who enroll in the study may identify a caregiver to participate in the trial. The caregiver will follow the randomization of the patient. Caregivers of patients randomized to transplant care alone will receive usual transplant care per hospital guidelines.

Transplant Care Alone Caregivers

* Patients will complete baseline self-report assessments at the time of obtaining informed consent
* Patients randomized to the intervention will receive the palliative care intervention during their hospitalization for transplant in addition to standard transplant care. the palliative care intervention entails having palliative care clinicians see patients at least twice weekly during hospitalization for transplant.

Inpatient Palliative Care Intervention - Patients

Transplant Care Alone - Patients

- Caregivers will be randomized based on the patient's randomization. they complete baseline assessment. if the patient is randomized to the palliative care intervention, the caregiver is also considered in this arm. they are permitted to attend the palliative care visits with the patients during hospitalization for transplant.

Inpatient Palliative Care - Caregivers

Caregivers complete baseline assessments and are randomized based on the random assignment of the patient. if the patient is randomized to standard transplant care, then the caregiver is randomized to standard transplant care.

Transplant Care Alone- Caregivers

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Areej El-Jawahri

* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent
* Palliative Care Intervention
* Therapeutic Relationship

  --Develop a strong therapeutic relationship with patients and caregivers
* Assessment and Treatment of Patient Symptoms

  --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms
* Managing Patients and Caregivers Expectations

  --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects
* Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support)

Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms

Inpatient Palliative Care Intervention

* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent.
* Standard Transplant Care

Standard Transplant Care: Standard care per hospital guidelines

Transplant Care Alone

Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

Patients' Quality of Life (QOL) Longitudinally: FACT-BMT

Patients' Symptom Burden

Patients' Fatigue

Patients' Psychological Distress

Patients' Depression

Patients' Post-traumatic Stress Symptoms (PTSD)

Caregiver QOL: CARGOQOL

Caregiver Psychological Distress

Caregiver Depression

Patient Coping

Caregiver Coping

Mediation Analysis (Symptom Burden and Coping) as Mediators of Improvement in Patient-reported QOL

Moderation Analysis to Examine Whether Patient or Transplant Related Characteristics Are Moderators of the Effect of the Intervention on Patient-reported QOL

* Patients will complete baseline self-report assessments at the time of obtaining informed consent
* Palliative Care Intervention entails having patients seen by a palliative care clinician during their hospitalization for HCT at least twice weekly throughout the transplant hospitalization

Inpatient Palliative Care Intervention Patients

Transplant Care Alone Patients

Patients enrolled in the study and randomized to inpatient palliative care can identify a caregiver who is willing to participate in the study. Patients without an eligible caregiver are still eligible to participate.

Caregivers will receive the palliative care intervention based on the patient assignment. Caregivers will be allowed to attend palliative care visits with the patients.

Inpatient Palliative Care Caregivers

Caregivers of patients randomized to transplant care alone will receive standard transplant care offered by the hospital.

Overall Study

These patients will receive the palliative care intervention.

Myrick C Shinall, MD

Frequently people diagnosed with cancer experience physical and emotional symptoms during the course of their disease. These symptoms can be very distressing to both the patient and the family members. The study doctor wants to know if the introduction of a team of clinicians that specialize in the lessening of many of these distressing symptoms may improve your overall care. This team of clinicians is called the palliative care team and they focus on ways to improve your pain and other symptom management (i.e. shortness of breath, fatigue, anxiety, etc.) and to assist you and your family in coping with the emotional, social, and spiritual issues associated with your diagnosis. The team consists of physicians, advanced practice nurses, case managers, and nurses who have been specially trained in the care of patients facing serious illness.

This research study is being done because although many people with cancer receive palliative care late in the course of their illness, the study team thinks palliative care may be more useful when it is started earlier and in this case before surgery. The main purpose of this study is to compare two types of care -usual surgery and cancer care and usual surgery and cancer care with comprehensive palliative care services to see which is better for improving the experience of patients and families with cancer.

The Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial is an investigation that will study the effect of a palliative care implementation during the preoperative, perioperative, and postoperative phase for adults undergoing cancer surgery for selected gastrointestinal and genitourinary malignancies. SCOPE will be a single-blind, single-institution randomized controlled trial of 236 patients. Intervention arm patients will receive a preoperative outpatient specialty palliative care consultation from a palliative care provider (physician or nurse practitioner) in addition to inpatient and outpatient palliative care follow-up postoperatively. Control arm patients will receive usual care with palliative care available at the discretion of the primary treatment team (currently these patients rarely get palliative care and usually only in the last weeks of life). The central hypothesis of the SCOPE Trial is that preoperative, perioperative, and postoperative specialty palliative care will improve patient functioning and quality of life in patients undergoing resection of selected GI and GU malignancies.

Surgery for Cancer With Option of Palliative Care Expert

Surgery for Cancer With Option of Palliative Care Expert: A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer

Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death

PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression

PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety

Number of days from operation until adjuvant chemotherapy or radiation is initiated

The answer to the following question: Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay?

Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma

Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden

Patient report of whether or not he or she is currently employed (yes/no question) and if yes, whether the employment is full-time or part-time

Patient report of whether he or she lives in a private residence or in a healthcare facility (i.e. assisted living, long-term care facility, nursing home, etc.)

Life Space Assessment Questionnaire score--a five item scale with scores from 0-120 with higher scores indicating larger life space i.e. larger area traversed during daily activities

Care-giver report of whether patient died in a private residence or in a healthcare facility such as a nursing home, hospital, or inpatient hospice facility

The FACT-G has 27 questions using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored. Questions measure the respondents' health state over the last 7 days in four subscales: Physical Well-Being (PWB, 7 questions), Social/Family Well-Being (SWB, 7 questions), Emotional Well-Being (EWB, 6 questions), and Functional Well-being (FWB, 7 questions). The Trial Outcome Index (TOI) is the sum of the Physical Well-Being and Functional Well-Being subscales. The TOI is an efficient summary index of physical/functional outcomes and is a common endpoint used in clinical trials.

Total score of all four subscales of the FACT-G instrument as described above

A count of all the days that the patient 1) has no emergency room visits, and 2) is not an inpatient of a hospital or other health-care facility

Score on the PTSD Checklist-Civilian Version--a 17-item scale scored from 17-85 with higher scores indicating more PTSD symptoms

Vanderbilt University Medical Center

Assistant Professor of Surgery

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Leukemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Participants will be randomly assigned, and stratified by disease, to the PEACE Group.

* Participants will meet with palliative care (PC) clinician within 1 week of T-cell collection and within 72 hours of hospital admission for ACT.
* Participants will meet with PC clinician at least 2 x weekly during hospitalization.
* PC clinician will follow participants up to one year after randomization (or enrollment for the open pilot) and will meet participant at least 2 x weekly during inpatient hospitalizations.
* Participants will complete follow-up study assessments on pre-determined days per protocol. The assessments will be filled out remotely or via paper.
* Participants will complete exit interviews in the open pilot only.

Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT.

* Palliative care (PC) intervention tailored to ACT recipients and addressing multiple PC domains with the input of ACT clinical experts, PC clinicians, and patients and caregivers.
* Domains discussed include therapeutic relationship, symptom management, prognostic awareness and illness understanding, coping with illness, treatment decision-making, EOL care.
* The palliative care intervention will be refined for the randomized control trial based on the feedback from the open pilot.

Palliative Care

Standard care for ACT per the treating team.

Usual Care

Patrick C Johnson

Patrick C Johnson, MD

The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups.

The names of the study intervention groups involved in this study are:

* Palliative care (PEACE) plus usual oncology care
* Usual care (standard oncology care)

Participation in this research study is expected to last for up to 2 years.

It is expected that about 90 people will take part in this research study.

This is a single-center, parallel-group, randomized controlled study to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT).

10 participants with planned ACT will be enrolled into an open pilot and will receive a palliative care intervention (PEACE) for the duration of treatment. Once the palliative care intervention has been refined by feedback from the pilot participants, the study will enroll 80 participants and will randomly assign the participants into one of two study intervention groups. Randomization means that a participant is put into a group by chance.

The names of the study intervention groups involved in this study are:

* Palliative care intervention (PEACE) plus usual oncology care
* Usual care (standard oncology care)

Participation in this research study is expected to last for up to 2 years.

It is expected that about 90 people will take part in this research study.

The American Society of Clinical Oncology is supporting this research study by providing funding support.

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Defined as at least 60% of eligible participants enrolling in the study, and among those enrolled and randomized to PEACE, 80% receiving PEACE as intended.

Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores \>=20.

Defined by Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item questionnaire that assesses cancer domains of physical well-being, social/family well-being, and emotional and functional well-being.

Assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), which is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)

Defined by Post-Traumatic Stress Disorder Checklist (PCL), comprised of 17 items that corresponds to key symptoms of PTSD.

Defined by Edmonton Symptom Assessment (ESAS-R), which is a 10-item measure to assess symptoms relevant to patients undergoing adoptive cellular therapy

Defined by Brief COPE which is comprised of 14 items that assesses the degree to which a participant utilizes specific coping strategies.

Defined by Perception of Treatment and Prognosis (PTPQ), a survey that assesses participant understanding of illness and prognosis.

Defined by PTPQ, a survey that assesses participant understanding of illness and prognosis and includes an item on patient-reported end-of-life communication.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation	NCT03641378	Stem Cell Trans...	Palliative Care... Standard Transp...	18 Years -	Massachusetts General Hospital
Surgery for Cancer With Option of Palliative Care Expert	NCT03436290	Cancer	Palliative Care...	18 Years -	Vanderbilt University Medical Center
Surgery for Cancer With Option of Palliative Care Expert	NCT03436290	Cancer	Palliative Care...	18 Years -	Vanderbilt University Medical Center
Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy	NCT05646576	Hematologic Mal... Blood Cancer Lymphoma Leukemia Multiple Myelom...	Palliative Care Usual Care	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for palliative care intervention