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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| University Medical Center New Orleans | OTHER |
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Through this award, Michael Hoerger, PhD, MSCR, a psychologist at the Tulane Cancer Center in Louisiana, will lead a study called EMPOWER 3 designed to test an educational intervention to help patients understand palliative care, use it, and feel better emotionally and physically. Participants will be adults with serious cancer diagnoses. Participants will be randomized into two groups. Patients in the control group will get enhanced usual care, meaning standard cancer care and several additional healthcare-related brochures. Patients in the intervention group will get enhanced usual care plus an educational video developed by the investigators and other materials designed to increase understanding and use of palliative care. Family members of patients in the intervention group may also attend if desired. The investigators will track participants' understanding of palliative care, attitudes toward palliative care, symptoms over 6 months of follow-up, and palliative care utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimedia Psychoeducational Intervention + Enhanced Usual Care | Experimental | Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care |
|
| Enhanced Usual Care | Other | Control participants receive Enhanced Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimedia Psychoeducational Intervention | Behavioral | The Multimedia Psychoeducational Intervention includes a multimedia educational video plus additional resources to reinforce the video content. The Multimedia Psychoeducational Intervention includes the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1: Palliative Care Knowledge Scale (PaCKS) | Percentage correct on 13 items; higher scores indicate greater knowledge | Post-test of Visit 1, typically day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 2a: Palliative Care Attitudes Scale (PCAS-9) | Total score from 0-36; higher scores indicate more positive attitudes | Post-test of Visit 1, typically day 1 |
| Aim 2b: Palliative Care Utilization |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Brief COPE Inventory | Total score from 6-24 on 6 Brief COPE Inventory items measuring denial, acceptance (reverse-coded), and self-blame; higher scores indicate less effective coping | Follow-up at 14 days |
| Exploratory: PROMIS Anger |
Inclusion Criteria:
Adult, age 18 or older
Meets criteria for 2a or 2b. 2a) The patient's doctor believes they may be appropriate for palliative cancer care OR 2b) The patient has a new diagnosis, recurrence, or progression of cancer in the past 90 days AND any of the following:
Advanced cancer, such as:
Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell
Breast Cancer: Stage IV
Gastrointestinal (GI) Cancers: Unresectable stage III or stage IV
Genitourinary (GU) Cancers: Stage IV
Melanoma: Stage IV
Hematologic Malignancies
Advanced heart, lung, renal (kidney), or liver disease
Two or more severe symptoms (≥7 on 0-10 scale): pain, tiredness, drowsiness, nausea, bad appetite, shortness of breath, depression, or anxiety
Patient can understand spoken or written English
Patient receives care in southeast Louisiana
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Hoerger, PhD, MSCR, MBA | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | New Orleans | Louisiana | 70112 | United States | ||
| Tulane University |
IPD can be shared with other researchers upon completing a data usage agreement signed by all participating universities.
By the study end date, available for at least 3 years.
Contact the Study PI
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| Enhanced Usual Care | Behavioral | Enhanced Usual Care refers to usual care plus minor enhancement to improve quality and standardization. Enhanced Usual Care includes the following:
|
|
Utilization of palliative care (presence/absence)
| Up to 90 days |
| Aim 3a: Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions | Total score from 8-40 on 8 items from PROMIS self-efficacy for managing symptoms and self-efficacy for managing emotions items banks; higher scores indicate greater self-efficacy | Follow-up at 14, 90, and 180 days |
| Aim 3b: PROMIS Emotional Distress | Total score from 8-40 on 8 items from the PROMIS Depression and Anxiety item banks; higher scores indicate greater symptom severity | Follow-up at 14, 90, and 180 days |
| Aim 3c: Edmonton Symptom Assessment Scale (ESAS)-Physical | Total score from 0-60 on 6 ESAS ratings of pain, tiredness, drowsiness, nausea, poor appetite, and difficulty breathing; higher scores indicate greater symptom severity | Follow-up at 14, 90, and 180 days |
Total score from 2-10 on 2 items from the PROMIS Anger item bank; higher scores indicate more anger
| Follow-up at 90 days |
| Exploratory: PROMIS Positive Affect | Total score from 2-10 on 2 items from the PROMIS Positive Affect item bank; higher scores indicate more positive affect | Follow-up at 90 days |
| Exploratory: PROMIS Stress | Total score from 4-20 on 4 items from the PROMIS Stress item bank; higher scores indicate more stress | Follow-up at 90 days |
| Exploratory: PROMIS General Self-Efficacy | Total score from 4-20 on 4 items from the PROMIS General Self-Efficacy item bank; higher scores indicate more stress | Follow-up at 90 days |
| Exploratory: Medication Adherence | Rating from 1-6 (Very poor to Excellent) for quality of medication adherence in the past 30 days; higher scores indicate better adherence | Follow-up at 90 days |
| Exploratory: PROMIS Emotional Support | Total score from 2-10 on 2 items from the PROMIS Emotional Support item bank; higher scores indicate more emotional support | Follow-up at 180 days |
| Exploratory: PROMIS Cognitive Function | Total score from 4-20 on 4 items from the PROMIS Cognitive Function item bank; higher scores indicate better cognitive function | Follow-up at 180 days |
| Exploratory: PROMIS Meaning and Purpose | Total score from 2-10 on 2 items from the PROMIS Meaning and Purpose item bank; higher scores indicate more meaning and purpose | Follow-up at 180 days |
| Exploratory: Quality of Life in Neurologic Disorders (Neuro-QoL) Concern with Death and Dying | Total score from 2-10 on 2 items from the Neuro-QoL Concern with Death and Dying item bank; ; higher scores indicate more concern | Follow-up at 180 days |
| New Orleans |
| Louisiana |
| 70115 |
| United States |