Cancer Terminal
Conditions
Brief summary
Our long-term goal is to improve spiritual care outcomes for elderly patients with cancer. The study team will use a spiritual intervention, Dignity Therapy (DT), to help these patients maintain pride, find spiritual comfort, enhance continuity of self, and ultimately make meaning of their life threatening illness.
Detailed description
The study team propose a 3 arm pre/posttest, RCT with a 4-step (approximately 12 months per step), stepped-wedge design to compare effects of usual outpatient palliative care (usual care) and usual care along with either nurse-led or chaplain-led DT on patient outcomes, cancer prognosis awareness. The study team will assign 6 outpatient palliative care sites to usual care during the first-step, and randomly assign two sites per step to begin and continue DT led by either a nurse or a chaplain during each of the next 3 steps. During the usual care steps, 280 patients will complete pretest measures and satisfaction with palliative spiritual care services, receive usual palliative care, and complete posttest measures. During the experimental steps as part of routine palliative care service delivery, 280 patients will complete pretest measures, receive nurse-led or chaplain-led DT, and complete posttest measures. Using mixed level analysis with site, provider (nurse, chaplain) and time (step) included in the model, the study team will compare the usual care and each of the DT groups for effects on dignity impact, existential tasks, and cancer prognosis awareness and explore the moderating effects of physical symptoms and spiritual distress. The study team will also determine the effect of usual care and DT on the patient's satisfaction with palliative spiritual care services and the report of the patient's unmet spiritual needs.
Interventions
BEHAVIORALDignity Therapy - Nurse Led
The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
BEHAVIORALUsual care
Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
BEHAVIORALDignity Therapy - Chaplain Led
The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
Sponsors
National Cancer Institute (NCI)
Northwestern University
Rush University
Emory University
M.D. Anderson Cancer Center
University of California, San Francisco
Healthcare Chaplaincy
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
a 6-site, pre/posttest, randomized, controlled 4-step, stepped-wedge design to compare the effects of usual outpatient palliative care (arm 1) and usual outpatient palliative care along with nurse-led (arm 2) or chaplain-led (arm 3) DT on patient outcomes and palliative care processes. The study team will assign the 6 sites to usual care during the first-step period (approximately 12 months), and randomly assign 2 sites per step to begin and continue DT during each of the next 3 steps (12 months each).
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. cancer diagnosis (receiving cancer therapy or cancer control care) 2. receiving outpatient palliative care 3. age 55 years or older 4. able to speak and read English 5. physically able to complete the study (Palliative Performance Scale \[PPS\]\>50, suggesting a mean in life expectancy of 53 days at the time of enrollment since each patient is expected to participate in the study for 28-42 days maximum \[4-6 weeks\]).
Exclusion criteria
1. legally blind 2. cognitively unable to complete study measures (Mini Mental Status Exam \[MMSE\] does not correctly spell the word world backwards) 3. history of psychosis (medical record review) 4. Patient Dignity Inventory score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated \>2 & 50% with high distress ≥ 3 problems rated \>2) 5. Spiritual distress score that indicates their distress level falls outside the remaining quota for a given step (quota is 50% of sample/site/step with low distress ≤ 2 problems rated \>2 & 50% with high distress ≥ 3 problems rated \>2) 6. are participating in another psychosocial intervention study that is focused on concepts similar to the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dignity Impact Scale | 5 weeks | Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preparation | 5 weeks | Preparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes. |
| Completion | 5 weeks | Life completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes. |
| Peaceful Awareness | 5 weeks | We measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure. |
| Treatment Preference | 5 weeks | We measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Outpatient Palliative Care During the usual care steps, patients will receive usual outpatient palliative care
Usual care: Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR. | 262 |
| Dignity Therapy - Nurse Led During the experimental steps as part of routine palliative care service delivery, patients receive nurse-led DT.
Dignity Therapy - Nurse Led: The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. | 129 |
| Dignity Therapy - Chaplain Led During the experimental steps as part of routine palliative care service delivery, patients will receive chaplain-led DT.
Dignity Therapy - Chaplain Led: The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience. | 188 |
| Total | 579 |
Baseline characteristics
| Characteristic | Total | Usual Outpatient Palliative Care | Dignity Therapy - Nurse Led | Dignity Therapy - Chaplain Led |
|---|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 7.4 | 67.2 years STANDARD_DEVIATION 7.5 | 65.7 years STANDARD_DEVIATION 7.1 | 65.8 years STANDARD_DEVIATION 7.5 |
| Completion | 27.0 units on a scale (7-35) higher=better STANDARD_DEVIATION 5.6 | 26.8 units on a scale (7-35) higher=better STANDARD_DEVIATION 5.2 | 26.4 units on a scale (7-35) higher=better STANDARD_DEVIATION 5.9 | 27.9 units on a scale (7-35) higher=better STANDARD_DEVIATION 5.7 |
| Dignity Impact Scale | 25.0 units on a scale (7-35) higher=better STANDARD_DEVIATION 4.4 | 25.9 units on a scale (7-35) higher=better STANDARD_DEVIATION 4.3 | 24.3 units on a scale (7-35) higher=better STANDARD_DEVIATION 4.3 | 24.2 units on a scale (7-35) higher=better STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 13 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 531 Participants | 243 Participants | 120 Participants | 168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 6 Participants | 3 Participants | 6 Participants |
| Peaceful Awareness Not peacefully aware | 448 Participants | 203 Participants | 97 Participants | 148 Participants |
| Peaceful Awareness Peacefully aware | 131 Participants | 59 Participants | 32 Participants | 40 Participants |
| Preparation | 15.0 units on a scale (4-20) higher=better STANDARD_DEVIATION 3.4 | 15.4 units on a scale (4-20) higher=better STANDARD_DEVIATION 3.2 | 14.5 units on a scale (4-20) higher=better STANDARD_DEVIATION 3.3 | 14.8 units on a scale (4-20) higher=better STANDARD_DEVIATION 3.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 68 Participants | 21 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 9 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 448 Participants | 182 Participants | 103 Participants | 163 Participants |
| Sex: Female, Male Female | 342 Participants | 147 Participants | 88 Participants | 107 Participants |
| Sex: Female, Male Male | 237 Participants | 115 Participants | 41 Participants | 81 Participants |
| Treatment Preference Attempt to cure but re-evaluate often | 178 Participants | 88 Participants | 40 Participants | 50 Participants |
| Treatment Preference Limit to less invasive and less burdensome interventions | 122 Participants | 55 Participants | 29 Participants | 38 Participants |
| Treatment Preference Prolong life; treat everything | 70 Participants | 37 Participants | 16 Participants | 17 Participants |
| Treatment Preference Provide comfort care only | 209 Participants | 82 Participants | 44 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 10 / 262 | 9 / 129 | 19 / 188 |
| other Total, other adverse events | 0 / 262 | 0 / 129 | 0 / 188 |
| serious Total, serious adverse events | 0 / 262 | 0 / 129 | 0 / 188 |
Outcome results
Primary
Dignity Impact Scale
Our primary outcome measure is a 7-item Dignity Impact Scale. The items are scored on a 5-point scale from 'strongly disagree' (1) to 'strongly agree' (5). The scores can range from 7 to 35 with higher scores representing better outcome.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Outpatient Palliative Care | Dignity Impact Scale | 26.3 score on a scale | Standard Deviation 4.7 |
| Dignity Therapy - Nurse Led | Dignity Impact Scale | 26.2 score on a scale | Standard Deviation 4.1 |
| Dignity Therapy - Chaplain Led | Dignity Impact Scale | 26.2 score on a scale | Standard Deviation 4.2 |
p-value: 0.02Regression, Linear
p-value: 0.005Regression, Linear
Secondary
Completion
Life completion subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 7 to 35 with higher scores representing better outcomes.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Outpatient Palliative Care | Completion | 27.0 score on a scale | Standard Deviation 4.9 |
| Dignity Therapy - Nurse Led | Completion | 27.2 score on a scale | Standard Deviation 4.9 |
| Dignity Therapy - Chaplain Led | Completion | 28.2 score on a scale | Standard Deviation 4.7 |
p-value: 0.21Regression, Linear
p-value: 0.21Regression, Linear
Secondary
Peaceful Awareness
We measured peaceful awareness with the 2 items: terminal illness awareness and peaceful awareness questionnaire. The first focused on terminal illness acknowledgement (TIA) in which patients rated their current health status as 1) relatively healthy, 2) seriously but not terminally ill, or 3) seriously and terminally ill. The second item focused on the frequency of feeling deep inner peace or harmony, which was rated on a 6-point Likert scale ranging from 1) never or almost never to 6) many times a day. Scores of at least 3 on each of the two items defined positive peaceful awareness, a dichotomous measure.
Time frame: 5 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Outpatient Palliative Care | Peaceful Awareness | Peacefully aware | 61 Participants |
| Usual Outpatient Palliative Care | Peaceful Awareness | Not peacefully aware | 201 Participants |
| Dignity Therapy - Nurse Led | Peaceful Awareness | Peacefully aware | 31 Participants |
| Dignity Therapy - Nurse Led | Peaceful Awareness | Not peacefully aware | 98 Participants |
| Dignity Therapy - Chaplain Led | Peaceful Awareness | Not peacefully aware | 144 Participants |
| Dignity Therapy - Chaplain Led | Peaceful Awareness | Peacefully aware | 44 Participants |
p-value: 0.11Regression, Logistic
p-value: 0.14Regression, Logistic
Secondary
Preparation
Preparation for death subscale taken from the QUAL-E, a measure designed to evaluate quality of life and to assess the effectiveness of interventions targeted to improve the quality of life at the end of life. Scores range from 4 to 20 with higher scores representing better outcomes.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Outpatient Palliative Care | Preparation | 15.6 score on a scale | Standard Deviation 3.2 |
| Dignity Therapy - Nurse Led | Preparation | 14.7 score on a scale | Standard Deviation 3.2 |
| Dignity Therapy - Chaplain Led | Preparation | 14.9 score on a scale | Standard Deviation 3.3 |
p-value: 0.21Regression, Linear
p-value: 0.12Regression, Linear
Secondary
Treatment Preference
We measured treatment preferences with a single item from the standardized and validated Hypothetical Advanced Care Planning Scenario (H-CAP-S) that assesses treatment preferences.
Time frame: 5 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Outpatient Palliative Care | Treatment Preference | Prolong life; treat everything | 24 Participants |
| Usual Outpatient Palliative Care | Treatment Preference | Attempt to cure but re-evaluate often | 91 Participants |
| Usual Outpatient Palliative Care | Treatment Preference | Limit to less invasive and less burdensome intervention | 56 Participants |
| Usual Outpatient Palliative Care | Treatment Preference | Provide comfort care only | 91 Participants |
| Dignity Therapy - Nurse Led | Treatment Preference | Provide comfort care only | 45 Participants |
| Dignity Therapy - Nurse Led | Treatment Preference | Limit to less invasive and less burdensome intervention | 25 Participants |
| Dignity Therapy - Nurse Led | Treatment Preference | Prolong life; treat everything | 15 Participants |
| Dignity Therapy - Nurse Led | Treatment Preference | Attempt to cure but re-evaluate often | 44 Participants |
| Dignity Therapy - Chaplain Led | Treatment Preference | Provide comfort care only | 81 Participants |
| Dignity Therapy - Chaplain Led | Treatment Preference | Attempt to cure but re-evaluate often | 45 Participants |
| Dignity Therapy - Chaplain Led | Treatment Preference | Limit to less invasive and less burdensome intervention | 51 Participants |
| Dignity Therapy - Chaplain Led | Treatment Preference | Prolong life; treat everything | 11 Participants |
p-value: 0.05Regression, Linear
p-value: 0.46Regression, Linear