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This is a pilot study to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention among 20 older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Older adults with AML and MDS are more likely to receive aggressive care and less likely to utilize hospice at the end-of-life. Advance care planning (ACP) intervention delivered through telehealth may improve patient-reported outcomes and end-of-life care in this population. This pilot study seeks to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention. We will adapt the Serious Illness Care Program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Experimental | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. |
|
| Caregiver | Experimental | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. |
|
| Oncology and Palliative Provider | Experimental | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth | Behavioral | Telehealth ACP intervention advance care planning intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Retention Rate | Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components | 12 Weeks |
| Recruitment Rate | Number of patients, caregivers, and clinicians who are approached and agree to enroll. | 12 Weeks |
| Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ) | Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7, a higher score indicates greater usability) assessing the usability of telehealth implementation across the population (for patients or caregivers), the mean of all questions is then calculated, range 1-7, with an average of greater than 5 considered usable. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7) | General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms) | 12 Weeks |
| Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9) |
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Inclusion Criteria for Patients:
Exclusion Criteria: N/A
Inclusion Criteria for Caregivers
Exclusion Criteria: N/A
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| Name | Affiliation | Role |
|---|---|---|
| Kah Poh Loh | Univ. of Rochester Wilmot Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38935428 | Derived | LoCastro M, Wang Y, Yu T, Mortaz-Hedjri S, Mendler J, Norton S, Bernacki R, Carroll T, Klepin H, Wedow L, Goonan S, Erdos H, Bagnato B, Liesveld J, Huselton E, Kluger B, Loh KP. Clinicians' Perspectives on the Telehealth Serious Illness Care Program for Older Adults With Myeloid Malignancies: Single-Arm Pilot Study. JMIR Form Res. 2024 Jun 27;8:e58503. doi: 10.2196/58503. | |
| 38088668 |
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A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.
The data will be available for 7 years from accrual of the first subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention, advance care planning intervention For the control group, no telehealth visits were scheduled. |
| FG001 | Caregiver | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention, advance care planning intervention For the control group, no telehealth visits were scheduled. |
| FG002 | Clinician | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention, advance care planning intervention For the control group, no telehealth visits were scheduled. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The population consists of 20 patients, 6 caregivers, and 9 clinicians (1 clinician did not provide demographic data).
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention, advance care planning intervention For the control group, no telehealth visits were scheduled. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility - Retention Rate | Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components | Retention rate was focused for the patient and caregiver populations. | Posted | Count of Participants | Participants | 12 Weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention advance care planning intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Project Manager | University of Rochester Medical Center, Wilmot Cancer Institute | 585 410 5044 | cait_fallone@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2022 | Mar 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Control | Behavioral | For the control arm, no telehealth visit will be scheduled. |
|
Patient Health Questionnaire-9 (PHQ-9): A 9-item valid and reliable screening tool depression in the general population (range 0-27, higher score indicates greater depressive symptoms). |
| 12 Weeks |
| Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer | Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level). | 12 Weeks |
| Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): Consists of 17 questions on the general module and 17 leukemia-specific questions, score ranges from 0-176, higher score indicates better quality of life). | 12 Weeks |
| Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ) | Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' satisfaction with patient-oncologist communication (12 items, range from 12-60), higher score indicates greater satisfaction with communication. | 12 weeks |
| Derived |
| LoCastro M, Mortaz-Hedjri S, Wang Y, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Liesveld J, Huselton E, Kluger B, Loh KP. Telehealth serious illness care program for older adults with hematologic malignancies: a single-arm pilot study. Blood Adv. 2023 Dec 26;7(24):7597-7607. doi: 10.1182/bloodadvances.2023011046. |
| 36521100 | Derived | LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin HD, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger B, Loh KP. Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. Blood Adv. 2023 May 9;7(9):1871-1884. doi: 10.1182/bloodadvances.2022008996. |
| Caregiver |
The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention, advance care planning intervention For the control group, no telehealth visits were scheduled. |
| BG002 | Clinician | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention, advance care planning intervention For the control group, no telehealth visits were scheduled. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 20 patients were included in the population of the study. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 20 patients were included in the population of the study. | Count of Participants | Participants |
|
| OG002 | Clinician | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention, advance care planning intervention For the control group, no telehealth visits were scheduled. |
|
|
| Primary | Recruitment Rate | Number of patients, caregivers, and clinicians who are approached and agree to enroll. | There are 29 patients analyzed because that many were approached, then 21 consented. One patient consented but withdrew before the intervention was initiated, leaving 20 enrolled participants. There were 7 caregivers approached, but 1 caregiver withdrew due to medical reasons. All 10 clinicians approached consented. | Posted | Count of Participants | Participants | 12 Weeks |
|
|
|
| Primary | Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ) | Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7, a higher score indicates greater usability) assessing the usability of telehealth implementation across the population (for patients or caregivers), the mean of all questions is then calculated, range 1-7, with an average of greater than 5 considered usable. | Usability was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers answered the survey. The clinicians were not included in the population of this aim. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7) | General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms) | General Anxiety Disorder-7 was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9) | Patient Health Questionnaire-9 (PHQ-9): A 9-item valid and reliable screening tool depression in the general population (range 0-27, higher score indicates greater depressive symptoms). | Patient Health Questionnaire-9 was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer | Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level). | Distress Thermometer was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): Consists of 17 questions on the general module and 17 leukemia-specific questions, score ranges from 0-176, higher score indicates better quality of life). | Functional Assessment of Cancer Therapy-Leukemia was an optional assessment, and 2 patients opted not to complete the survey. Therefore, data was not collected. The caregivers and clinicians were not included in the population of this aim. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ) | Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' satisfaction with patient-oncologist communication (12 items, range from 12-60), higher score indicates greater satisfaction with communication. | Health Care Communication Questionnaire was an optional assessment, and 2 participants opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 1 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Caregivers | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention advance care planning intervention | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Clinicians | The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Telehealth: Telehealth ACP intervention advance care planning intervention | 0 | 10 | 0 | 10 | 0 | 10 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |