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

* Six psychological intervention sessions in-person or via video conferencing conducted by a trained psychologist
* The CARE intervention contain 3 component

  * a psychoeducational component to address preparednessmanage expectations, and develop caregiving skills
  * a psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertainty
  * a self-care component to promote caregiver health and well-being

* Standard Transplant Care
* Social work consults to help caregivers only upon request

Promote effective coping and reduce caregiving burden.

CARE

Standard cared administered by the hospital.

This research study is evaluating the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant.

The purpose of this study is to find out whether a psychological intervention can make the experience of being a caregiver more manageable by improving the participant's quality of life, mood, and caregiving burden during the participant's loved one's transplant process.

The psychological intervention will entail six visits with a trained clinician and will take place during the first three months of the participant's loved ones' transplant process. A trained behavioral psychologist or social worker will meet with the participant or talk with the participant over the telephone or video conference for 45 minutes at a time to discuss the participant's caregiver experience and to help the participant develop effective skills to support the participant's loved one as well as participant over the course of the transplant.

The study will use a series of questionnaires to measure the participant's quality of life, mood, and overall caregiving burden. Study questionnaires will be completed in the hospital or clinic. The participant will also have the option of completing these questionnaires remotely through a secure web link, over the telephone, or in a mailed paper copy.

Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

Randomized Trial of a Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)

Feasibility defined if at least 60% of eligible caregivers are enrolled in the study and attend at least 50% of the intervention visits

we will compare caregiver QOL as measured by CarGOQOL at day +30 and day +90 after the intervention (adjusting for baseline values)

we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA) at day +30 and day +90 after the intervention (adjusting for baseline values)

We will compare caregiver mood use the Hospital Anxiety and Depression Scale (HADS) at day +30 and day +90 (controlling for baseline values). The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress))

We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) at day +30 and day +90 (controlling for baseline values). The scale ranges from 0 to 170 with higher scores indicate higher self efficacy

Compare caregiver coping skills using the Measure of Current Status (MOCS) between the study arms. Score ranges from 0-52, with higher scores indicating higher coping skills

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
Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant	NCT03328663	Cancer	CARE Standard Transp...	18 Years -	Massachusetts General Hospital
Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant	NCT03328663	Cancer	CARE Standard Transp...	18 Years -	Massachusetts General Hospital

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