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Completed

NCT Number: NCT02992171

Primary Palliative Care for Patients With Advanced Hematologic Malignancies

This study seeks to develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.

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Key information

Conditions

Advanced Cancer

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

About this study

Study investigators will develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.

Aim 1 is a case series to develop and refine the intervention. During this time, we will develop initial interventionist training materials, study protocols, and a web-based outcomes database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic malignancies and their informal caregivers to receive intervention visits; conduct debriefing interviews; iteratively refine the intervention based on nurse, oncologist, patient, and caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the feasibility and acceptability of administering the intervention and assessing outcomes. We will recruit 30 patients and their informal caregivers to receive the intervention developed in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to three months. Trial outcomes will include: rates of enrollment, study completion, and outcome completion; intervention fidelity; and self-reported measures of study burdensomeness and effectiveness among patients, caregivers, and clinicians.

Who can participate

Healthy volunteers accepted: No

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

Participants will be (1) patients with advanced hematologic malignancies receiving care at a participating clinic; (2) their caregivers; (3) participating clinicians.

Patient:

Inclusion criteria

  • adults (≥ 21 years old)
  • Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis (secondary manifestation myeloma & AL Amyloidosis), and CML (CML can only be accelerated or blast phase)
  • planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.

Exclusion criteria

  • chronic myeloid leukemia (CML) OTHER THAN accelerated or blast phase
  • unable to read and respond to questions in English
  • lacks decision-making capacity, as determined by the patient's oncologist
  • unable to complete baseline interview

Caregiver

Inclusion criteria

  • adults (≥ 21 years old)
  • family member or friend of an eligible patient

Exclusion criteria

  • unable to read and respond to questions in English
  • unable to complete the baseline interview (patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it)

Eligible clinicians will be oncology nurses and oncologists practicing at participating clinics.

Treatment and study plan

care management by oncology nurses

Behavioral

The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.

Primary outcomes

  1. Successful enrollment of 30 patient-caregiver pairs

    Time frame: Baseline to 3 months

Secondary outcomes

  1. Consent-to-approach rate

    Time frame: Baseline to 3 months

    Consent to approach rates will be tracked to assess feasibility

  2. Enrolled-to-consent rate

    Time frame: Baseline to 3 months

    Enrolled-to-consent rates will be tracked to assess feasibility

  3. Intervention completion rate

    Time frame: Baseline to 3 months

    Intervention completion rate among enrolled participants will be tracked to assess feasibility

  4. Intervention fidelity

    Time frame: Baseline to 3 months

    Percent of intervention components completed according to protocol will be tracked to assess feasibility

  5. Outcome assessment rate

    Time frame: Baseline to 3 months

    Outcome assessment rates among enrolled participants will be tracked to assess feasibility

  6. Missing data

    Time frame: Baseline to 3 months

    Missing data rates will be tracked to assess feasibility

  7. Acceptability

    Time frame: 3 months

    We will assess acceptability based on patient, caregiver, and clinician responses to closed-end survey questions. Definitions of adequate acceptability based on these surveys include:

    • > 80% of patient and caregiver participants would recommend the intervention to other patients with advanced hematologic malignancies and their caregivers.
    • > 80% of patient and caregiver participants agree or strongly agree that intervention visits have been helpful for (a) improving pain or other symptoms, (b) helping with illness understanding, (c) helping with coping, and (d) helping with planning for the future.
    • > 80% of oncologist participants disagree or strongly disagree that (a) working with intervention nurses has been burdensome or (b) the intervention has been disruptive to clinic workflow.
    • > 80% of oncologist and nurse participants agree or strongly agree that the intervention (a) has helped me to take better care of my patients and (b) has improved the quality of care.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2016
Registry last updated
Apr 24, 2020

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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