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NCT Number: NCT03641378

Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Stem Cell Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient Inclusion Criteria

  • adult patients (≥ 18 years) with hematologic malignancy admitted for autologous or allogeneic HCT.
  • ability to read and respond to questions in English or Spanish or to complete questionnaires with assistance from an interpreter.

Caregiver Eligibility Criteria:

  • adult (≥ 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week.
  • ability to read and respond to questions in English or Spanish or to complete questionnaires with the assistance of an interpreter.

Exclusion criteria

Patient Exclusion Criteria

  • Patients undergoing HCT for benign hematologic conditions
  • Patients undergoing outpatient HCT.
  • Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures

Treatment and study plan

Palliative Care Intervention

Other

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

Standard Transplant Care

Other

Standard care per hospital guidelines

Primary outcomes

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

    Time frame: 2 weeks

    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

Secondary outcomes

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

    Time frame: up to 6 months

    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

  2. Patients' Symptom Burden

    Time frame: up to 6 months

    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

  3. Patients' Fatigue

    Time frame: up to 6 months

    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

  4. Patients' Psychological Distress

    Time frame: up to 6 months

    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)

  5. Patients' Depression

    Time frame: up to 6 months

    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

  6. Patients' Post-traumatic Stress Symptoms (PTSD)

    Time frame: up to 6 months

    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

  7. Caregiver QOL: CARGOQOL

    Time frame: up to 6 months

    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.

  8. Caregiver Psychological Distress

    Time frame: up to 6 months

    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)

  9. Caregiver Depression

    Time frame: up to 6 months

    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.

Other outcomes

  1. Patient Coping

    Time frame: up to 1 year

    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.

  2. Caregiver Coping

    Time frame: up to 1 year

    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.

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

    Time frame: 2 week

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

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

    Time frame: 2 week

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Aug 22, 2018
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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