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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34NR019131 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This single institution feasibility and acceptability study includes patients with acute leukemia which is designed to examine a novel palliative and supportive care intervention (Palliative and supportive Care inTervention; PACT) in which registered nurses (RNs), occupational therapists (OTs), and physical therapists (PTs) address the activity needs of older adults with acute leukemia during their hospital stay.
The primary objective of the study is to assess feasibility, acceptability, and change in pre and post measures of symptoms, function, and QOL by administering the PACT intervention. The first 20 participants in the control group will receive usual care. The next 20 participants will receive the PACT intervention. Each participant in the intervention group will be cared by a collaborative, multidisciplinary, integrated team including RNs, OTs and PTs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients in the control arm will receive standard of care and no intervention. | |
| Intervention | Experimental | Patients in the intervention arm will receive the PACT intervention provided by a multidisciplinary team of RNs, OTs, and PTs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative And supportive Care inTervention (PACT) | Other | Using the Adaptive Leadership Framework for Chronic Illness as a guide. The nurse, occupational and physical therapists will meet with the patient and caregiver after the baseline assessment to discuss their Specific, Measurable, Achievable, Relevant, and Time-Bound (SMART) goals. Additionally, the occupational and physical therapists will provide the patient a PACT intervention binder. Regular phone calls or visits from a registered nurse, occupational therapists, and physical therapists for patients and caregivers in the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and Acceptability | Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study. | Baseline |
| Retention Rate | The rate of participants who consented to the study completed study intervention at the time point. | Baseline and up to 30 days (first and second cycles) |
| Symptom Monitoring Data Collection Rate | The number of participants who joined the study and symptom monitoring were assessed at the time point. | Baseline and up to 30 days (first and second cycles) |
| Caregiver Follow-Up Data Collection Rate | Caregiver Follow-Up data collection rate was assessed the number of caregiver participants who joined the study and symptom monitoring was assessed at the time points. | At second cycle (at days 30) |
| Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 1. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. |
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[Patient]
Inclusion Criteria:
Exclusion Criteria:
1. Patients receiving hospice care
[Caregiver]
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Bryant, PhD, RN | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Lineberger Comprehenisive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
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A total of seventy-two participants consented to the study, but five of them withdrew their consent during screening and therefore were not enrolled in the study.
Participants were recruited from 09/14/2020 through 04/06/2023 at one cancer center in North Carolina. Subjects were enrolled in the study between 09/14/2020 - 4/4/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients in the control arm will receive standard of care and no intervention. |
| FG001 | Intervention | Patients in the intervention arm will receive the PACT intervention. |
| FG002 | Care Partner -Control | Subjects who are family or friends or support patients in the control group |
| FG003 | Care Partner- Interventional | Subjects who are family or friends or support patients in the intervention group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects who were joined to the study. Care Partner -Control" and "Care Partner- Interventional" Arms were not assessed for this Baseline Measure support person and miles traveled to the clinic.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients in the control arm will receive standard of care and no intervention. |
| BG001 | Intervention | Patients in the intervention arm will receive the PACT intervention. |
| 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 and Acceptability | Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study. | Potential research participants screened. | Posted | Count of Participants | Participants | Baseline |
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The protocol does not require Adverse Event Collections and/or All-Cause Mortality data. Deaths and adverse events were not assessed.
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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 | Control | Patients in the control arm will receive standard of care and no intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melahat Canter | University of North Carolina Lineberger Comprehensive Cancer Center | 9199620000 | Melahat_Canter@med.unc.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 | Nov 24, 2020 | Mar 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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This is a feasibility study. This study is conducted on one unit and to reduce bias and contamination, the control patients will be recruited and consented first. After recruitment of the 20 control patients, we will then recruit 20 intervention patients.
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| Baseline, up to 30 days |
| Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 2. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. | 30 days after starting to the study |
| Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2. | Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the intervention arm both at Cycle 1 and 2. Score difference for each subject and mean differences between scores were calculated. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. | Baseline and until day 30 (Cycle 1 and Cycle 2) |
| Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | 19 items include diarrhea, chills, heartburn, nausea, appetite, mouth sores, vomiting, constipation, cough, rash, shortness of breath, fatigue, anxiety, sadness, nothing will cheer me up, pain, insomnia, concentration, and memory. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much." | Up to180 days |
| BG002 | Care Partner -Control | Subjects who are family or friends or support patients in the control group |
| BG003 | Care Partner- Interventional | Subjects who are family or friends or support patients in the intervention group. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
|
| Primary | Retention Rate | The rate of participants who consented to the study completed study intervention at the time point. | Subjects started the study and completed the study intervention. | Posted | Count of Participants | Participants | Baseline and up to 30 days (first and second cycles) |
|
|
|
| Primary | Symptom Monitoring Data Collection Rate | The number of participants who joined the study and symptom monitoring were assessed at the time point. | Subjects started the study and were assessed at the time point. | Posted | Count of Participants | Participants | Baseline and up to 30 days (first and second cycles) |
|
|
|
| Primary | Caregiver Follow-Up Data Collection Rate | Caregiver Follow-Up data collection rate was assessed the number of caregiver participants who joined the study and symptom monitoring was assessed at the time points. | Caregivers of subjects started the study and responded the questions at the time point. | Posted | Count of Participants | Participants | At second cycle (at days 30) |
|
|
|
| Primary | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1. | Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 1. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. | Subjects who were joined to the study and completed assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 30 days |
|
|
|
| Primary | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2. | Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 2. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. | Subjects who were joined to the study and completed the assessment on Cycle 2. | Posted | Mean | Standard Deviation | score on a scale | 30 days after starting to the study |
|
|
|
| Primary | Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2. | Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the intervention arm both at Cycle 1 and 2. Score difference for each subject and mean differences between scores were calculated. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. | Subjects who were joined to the study and responded to (EORTC QLQ-C30) questionnaire at Cycle 1 and Cycle 2. | Posted | Mean | Standard Deviation | score on a scale | Baseline and until day 30 (Cycle 1 and Cycle 2) |
|
|
|
| Primary | Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | 19 items include diarrhea, chills, heartburn, nausea, appetite, mouth sores, vomiting, constipation, cough, rash, shortness of breath, fatigue, anxiety, sadness, nothing will cheer me up, pain, insomnia, concentration, and memory. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much." | Subjects started the study and responded to the PRO-CTCAE questionnaire at the time point. | Posted | Count of Participants | Participants | Up to180 days |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intervention | Patients in the intervention arm will receive the PACT intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Care Partner -Control | Subjects who are family or friends or support patients in the control group | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Care Partner- Interventional | Subjects who are family or friends or support patients in the intervention group. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Cycle 2 |
|
| Cycle1 Emotional QoL |
|
| Cycle1 Fatigue |
|
| Cycle2 Emotional QoL |
|
| Cycle2 Fatigue |
|
| Title | Measurements |
|---|---|
|
| Fatigue |
|
| heartburn |
|
| nausea |
|
| appetite |
|
| mouth sores |
|
| vomiting |
|
| constipation |
|
| cough |
|
| rash |
|
| shortness of breath |
|
| fatigue |
|
| anxiety |
|
| sadness |
|
| nothing will cheer me up |
|
| pain |
|
| insomnia |
|
| concentration |
|
| memory |
|