An interventional study of Palliative And supportive Care inTervention (PACT) in Acute Myeloid Leukemia, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 67 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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[Patient]
Inclusion Criteria:
Exclusion Criteria:
[Caregiver]
Inclusion Criteria:
Patients in the control arm will receive standard of care and no intervention.
Patients in the intervention arm will receive the PACT intervention provided by a multidisciplinary team of RNs, OTs, and PTs.
Other: Palliative And supportive Care inTervention (PACT)
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.
Feasibility and Acceptability
Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study.
Time frame: Baseline
Retention Rate
The rate of participants who consented to the study completed study intervention at the time point.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: Up to180 days
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.
| Milestone | Control | Intervention | Care Partner -Control | Care Partner- Interventional |
|---|---|---|---|---|
| Started | 20 | 18 | 14 | 15 |
| Completed | 20 | 18 | 14 | 13 |
| Not completed | 0 | 0 | 0 | 2 |
Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study.
| Participants | Potential - Eligible- Consented Participants |
|---|---|
| Screened | 128 |
| Eligible | 93 |
| Approached | 54 |
| Consented | 38 |
The rate of participants who consented to the study completed study intervention at the time point.
| Participants | Control | Intervention |
|---|---|---|
| Consented | 20 | 18 |
| Cycle 1 | 20 | 18 |
| Cycle 2 | 15 | 15 |
The number of participants who joined the study and symptom monitoring were assessed at the time point.
| Participants | Control | Intervention |
|---|---|---|
| Cycle 1 | 17 | 12 |
| Cycle 2 | 14 | 10 |
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.
| Participants | Care Partner -Control | Care Partner- Interventional |
|---|---|---|
| Caregiver Follow-Up Data Collection Rate | 10 | 12 |
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.
| score on a scale | Control | Intervention |
|---|---|---|
| Cycle1 Overall QoL | 55.8 ± 22.6 | 52.8 ± 25.7 |
| Cycle1 Physical QoL | 72.3 ± 22.6 | 64.4 ± 27.7 |
| Cycle1 Emotional QoL | 83.3 ± 15.3 | 77.3 ± 22.3 |
| Cycle1 Fatigue | 49.4 ± 29.8 | 53.1 ± 30.1 |
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 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.
| score on a scale | Control | Intervention |
|---|---|---|
| Cycle2 Overall QoL | 64.4 ± 16.8 | 60.1 ± 20.5 |
| Cycle2 Physical QoL | 76.9 ± 18.0 | 72.9 ± 19.8 |
| Cycle2 Emotional QoL | 86.7 ± 10.8 | 87.5 ± 15.6 |
| Cycle2 Fatigue | 39.3 ± 17.2 | 54.0 ± 30.5 |
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.
| score on a scale | Intervention Group |
|---|---|
| Overall QOL | 5.36 ± 26.27 |
| Physical QOL | 3.81 ± 24.35 |
| Emotional QOL | 7.34 ± 13.66 |
| Fatigue | 4.76 ± 33.39 |
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."
| Participants | Control | Intervention |
|---|---|---|
| diarrhea | 9 | 13 |
| chills | 12 | 15 |
| heartburn | 7 | 13 |
| nausea | 8 | 14 |
| appetite | 11 | 15 |
| mouth sores | 8 | 15 |
| vomiting | 1 | 9 |
| constipation | 10 | 15 |
| cough | 8 | 15 |
| rash | 3 | 0 |
| shortness of breath | 9 | 15 |
| fatigue | 12 | 15 |
| anxiety | 9 | 14 |
| sadness | 8 | 14 |
| nothing will cheer me up | 7 | 11 |
| pain | 8 | 8 |
| insomnia | 11 | 15 |
| concentration | 10 | 14 |
| memory | 10 | 14 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | — | — |
| Intervention | — | — | — |
| Care Partner -Control | — | — | — |
| Care Partner- Interventional | — | — | — |
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.
| Age, Continuous(years) | Control | Intervention | Care Partner -Control | Care Partner- Interventional | Total |
|---|---|---|---|---|---|
| Mean | 74.7 ± 7.49 | 74 ± 6.75 | 65.6 ± 9.3 | 67.4 ± 13.12 | 70.43 ± 9.17 |
| Sex: Female, Male(Participants) | Control | Intervention | Care Partner -Control | Care Partner- Interventional | Total |
|---|---|---|---|---|---|
| Female | 15 | 13 | 13 | 12 | 53 |
| Male | 5 | 5 | 1 | 3 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Control | Intervention | Care Partner -Control | Care Partner- Interventional | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 20 | 14 | 12 | 14 | 60 |
| Unknown or Not Reported | 0 | 3 | 2 | 1 | 6 |
| Race (NIH/OMB)(Participants) | Control | Intervention | Care Partner -Control | Care Partner- Interventional | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 0 | 1 | 3 |
| Black or African American | 1 | 3 | 1 | 3 | 8 |
| White | 17 | 13 | 13 | 11 | 54 |
| More than one race | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control | Intervention | Care Partner -Control | Care Partner- Interventional | Total |
|---|---|---|---|---|---|
| United States | 20 | 18 | 14 | 15 | 67 |
| Education(Participants) | Control | Intervention | Care Partner -Control | Care Partner- Interventional | Total |
|---|---|---|---|---|---|
| 1st-8th grade | 0 | 2 | 0 | 0 | 2 |
| 9-11th grade | 0 | 0 | 1 | 2 | 3 |
| High school graduate/GED | 9 | 5 | 3 | 7 | 24 |
| College Degree | 4 | 10 | 6 | 5 | 25 |
| Advanced Degree | 6 | 1 | 4 | 1 | 12 |
| Prefer not to answer | 1 | 0 | 0 | 0 | 1 |
| Marital Status(Participants) | Control | Intervention | Care Partner -Control | Care Partner- Interventional | Total |
|---|---|---|---|---|---|
| Single, never married | 0 | 0 | 1 | 0 | 1 |
| Married/partnered | 14 | 14 | 12 | 14 | 54 |
| Divorced | 3 | 2 | 1 | 1 | 7 |
| separated | 0 | 1 | 0 | 0 | 1 |
| widowed | 3 | 1 | 0 | 0 | 4 |
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UNC Lineberger Comprehensive Cancer Center