Caregiver, Stage IA Lung Cancer AJCC v7, Stage IB Lung Cancer AJCC v7, Stage IIA Lung Cancer AJCC v7, Stage IIB Lung Cancer AJCC v7, Stage IIIA Lung Cancer AJCC v7, Stage IIIB Lung Cancer AJCC v7, Stage III Lung Cancer AJCC v7, Stage II Lung Cancer AJCC v7, Stage I Lung Cancer AJCC v7
Conditions
Brief summary
This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.
Detailed description
PRIMARY OBJECTIVES: I. Test the effects of the multimedia self-management (MSM) intervention on family caregivers (FCG) outcomes and cancer support services use at discharge and 3-month post-discharge, comparing intervention and attention control groups. II. Test the effects of the MSM intervention on patient outcomes and healthcare resource use at discharge and 3-months post-discharge, comparing intervention and attention control groups. III. Test the effects of the MSM intervention on outcome mediators at discharge and 3-months post-discharge, comparing intervention and attention control groups. SECONDARY OBJECTIVES: I. Explore moderators (age, sex, marital status, caregiver relationship to patient, caregiver employment status, co-morbidities) of FCG and patient outcomes and reciprocal relationships. II. Determine, through exit interviews, participant's experience with the MSM intervention. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support by telephone (separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge. GROUP II: Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a clinical research associate (CRA) approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone calls at 2 and 7 days, and 2 months post-discharge.
Interventions
OTHERInformational Intervention
Receive MSM intervention handbook
OTHERMedia Intervention
View the MSM intervention videos
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Family Caregiver Inclusion Criteria: * A family member or friend identified by the patient as being the primary care provider before and after surgery * A patient/care recipient enrolled in the study * Age 21 years or older * Able to read or understand English Patient Inclusion Criteria: * Diagnosis of Stage I-III non-small cell lung cancer * Scheduled to undergo surgery for treatment * A family caregiver enrolled in the study * Age 21 years or older * Able to read or understand English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean caregiver psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome. |
| Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean caregiver burden scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in burden between the intervention and control arm over time. The model included treatment arm, time, and the interaction between treatment arm and time as effects. Total burden score is calculated by summing items from 3 subscales: objective burden, subjective burden \& demand burden. Score range: 14-70. Higher score means worse outcome. |
| Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale) | Outcomes are measured before surgery (baseline), 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean caregiver preparedness scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in preparedness between the intervention and control arm over time. Score range: 0-4. Higher score means better outcome. |
| Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean caregiver QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total QoL score is calculated by summing items from 3 subscales: physical well-being, psychological well-being, social concerns \& spiritual well-being. Score range: 0-40. Higher score means better outcome. |
| Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory) | Outcomes are measured at discharge, 1 month, and 3 months post-discharge. | Differences in the number of caregivers who saw a support services specialist were compared between both groups using Chi-squared and Fisher's exact test. |
| Change in Patient Psychological Distress (as Measured by the Distress Thermometer) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean patient psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome. |
| Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean patient QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total FACT-L score is calculated by summing items from 5 subscales: physical well-being, social/family well-being, emotional well-being, functional well-being \& lung cancer subscale. Score range: 0-136. Higher score means better outcome. |
| Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions) | Outcomes are measured at 1 month, and 3 months post-discharge. | Differences in the number of patients who were readmitted to the hospital for an overnight stay were compared between both groups using Chi-squared and Fisher's exact test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean caregiver self-efficacy scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in self-efficacy between the intervention and control arm over time. Score range: 1-4. Higher score means better outcome. |
| Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean patient self-efficacy scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in self-efficacy between the intervention and control arm over time. Score range: 1-4. Higher score means better outcome. |
| Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean caregiver activation scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in activation between the intervention and control arm over time. Score range: 10-60. Higher score means better outcome. |
| Change in Patient Activation (as Measured by the Patient Activation Measure) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe. | Mean patient activation scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in activation between the intervention and control arm over time. Score range: 0-100. Higher score means better outcome. |
| Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge | Mean family caregiver knowledge scores from baseline to 3 months post-discharge were calculated. T-tests were used to assess differences in knowledge between the intervention and control arm at different timepoints. Score range: 0-10. Mean: 8.24 with a standard deviation of 1.19. Higher score means better outcome. |
| Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool) | Outcomes are measured at baseline, 1 month, and 3 months post-discharge | Mean patient knowledge scores from baseline to 3 months post-discharge were calculated. T-tests were used to assess differences in knowledge between the intervention and control arm at different timepoints. Score range: 0-10. Mean: 8.42 with a standard deviation of 1.16. Higher score means better outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVirginia Sun, RN, PhD
City of Hope Medical Center
PRINCIPAL_INVESTIGATORJae Kim, MD
City of Hope Medical Center
Participant flow
Recruitment details
542 participants (342 patients, 200 caregivers) were assessed for study eligibility. After 162 participants were excluded for various reasons - not meeting inclusion criteria (n= 91), declined to participate (n= 48), other/unknown reasons (n= 3), late ineligibility (n= 20), 380 participants (190 dyads - 190 patients, 190 caregivers) were randomized.
Pre-assignment details
542 participants (342 patients, 200 caregivers) were assessed for study eligibility. After 162 participants were excluded for various reasons - not meeting inclusion criteria (n= 91), declined to participate (n= 48), other/unknown reasons (n= 3), late ineligibility (n= 20), 380 participants (190 dyads - 190 patients, 190 caregivers) were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Group I (MSM Intervention) Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support via telephone(separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.
Informational Intervention: Receive MSM intervention handbook
Informational Intervention: Receive MSM intervention research nurse coaching
Media Intervention: View the MSM intervention videos
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 188 |
| Group II (Attention Control) Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on Clinical Trials), American Cancer Society print materials, and assistance from a CRA approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone at 2 and 7 days, and 2 months post-discharge.
Informational Intervention: Receive ASCO print materials
Informational Intervention: Receive CRA assistance
Media Intervention: View ASCO Cancer.net videos | 192 |
| Total | 380 |
Baseline characteristics
| Characteristic | Group I (MSM Intervention) | Total | Group II (Attention Control) |
|---|---|---|---|
| Age, Continuous | 67.5 years | 66.0 years | 65.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 48 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 153 Participants | 319 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 42 Participants | 85 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 29 Participants | 16 Participants |
| Race (NIH/OMB) White | 126 Participants | 244 Participants | 118 Participants |
| Region of Enrollment United States | 188 participants | 380 participants | 192 participants |
| Sex: Female, Male Female | 110 Participants | 226 Participants | 116 Participants |
| Sex: Female, Male Male | 77 Participants | 153 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 188 | 0 / 192 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)
Mean caregiver burden scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in burden between the intervention and control arm over time. The model included treatment arm, time, and the interaction between treatment arm and time as effects. Total burden score is calculated by summing items from 3 subscales: objective burden, subjective burden & demand burden. Score range: 14-70. Higher score means worse outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale) | Baseline | 44.68 score on a scale |
| Group I (MSM Intervention) | Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale) | 1 month post-discharge | 42.19 score on a scale |
| Group I (MSM Intervention) | Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale) | 3 months post-discharge | 40.45 score on a scale |
| Group II (Attention Control) | Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale) | Baseline | 44.56 score on a scale |
| Group II (Attention Control) | Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale) | 1 month post-discharge | 44.73 score on a scale |
| Group II (Attention Control) | Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale) | 3 months post-discharge | 42.00 score on a scale |
Primary
Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
Mean caregiver psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer) | Baseline | 3.92 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer) | 1 month post-discharge | 3.38 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer) | 3 months post-discharge | 3.22 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer) | Baseline | 4.19 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer) | 1 month post-discharge | 3.74 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer) | 3 months post-discharge | 4.14 score on a scale |
Primary
Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family)
Mean caregiver QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total QoL score is calculated by summing items from 3 subscales: physical well-being, psychological well-being, social concerns & spiritual well-being. Score range: 0-40. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | Baseline | 27.04 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | 1 month post-discharge | 27.69 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | 3 months post-discharge | 27.51 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | Baseline | 26.83 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | 1 month post-discharge | 26.67 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | 3 months post-discharge | 26.43 score on a scale |
Primary
Change in Patient Psychological Distress (as Measured by the Distress Thermometer)
Mean patient psychological distress scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in psychological distress between the intervention and control arm over time. Score range: 0-10. Higher score means worse outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Patient Psychological Distress (as Measured by the Distress Thermometer) | Baseline | 4.23 score on a scale |
| Group I (MSM Intervention) | Change in Patient Psychological Distress (as Measured by the Distress Thermometer) | 1 month post-discharge | 3.42 score on a scale |
| Group I (MSM Intervention) | Change in Patient Psychological Distress (as Measured by the Distress Thermometer) | 3 months post-discharge | 3.25 score on a scale |
| Group II (Attention Control) | Change in Patient Psychological Distress (as Measured by the Distress Thermometer) | Baseline | 4.39 score on a scale |
| Group II (Attention Control) | Change in Patient Psychological Distress (as Measured by the Distress Thermometer) | 1 month post-discharge | 3.55 score on a scale |
| Group II (Attention Control) | Change in Patient Psychological Distress (as Measured by the Distress Thermometer) | 3 months post-discharge | 3.76 score on a scale |
Primary
Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L)
Mean patient QoL scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in QoL between the intervention and control arm over time. Total FACT-L score is calculated by summing items from 5 subscales: physical well-being, social/family well-being, emotional well-being, functional well-being & lung cancer subscale. Score range: 0-136. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | Baseline | 106.09 score on a scale |
| Group I (MSM Intervention) | Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | 1 month post-discharge | 103.97 score on a scale |
| Group I (MSM Intervention) | Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | 3 months post-discharge | 103.54 score on a scale |
| Group II (Attention Control) | Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | Baseline | 104.27 score on a scale |
| Group II (Attention Control) | Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | 1 month post-discharge | 99.17 score on a scale |
| Group II (Attention Control) | Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | 3 months post-discharge | 101.04 score on a scale |
Primary
Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)
Mean caregiver preparedness scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in preparedness between the intervention and control arm over time. Score range: 0-4. Higher score means better outcome.
Time frame: Outcomes are measured before surgery (baseline), 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale) | Baseline | 2.55 score on a scale |
| Group I (MSM Intervention) | Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale) | 1 month post-discharge | 2.98 score on a scale |
| Group I (MSM Intervention) | Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale) | 3 months post-discharge | 2.94 score on a scale |
| Group II (Attention Control) | Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale) | 1 month post-discharge | 2.88 score on a scale |
| Group II (Attention Control) | Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale) | Baseline | 2.60 score on a scale |
| Group II (Attention Control) | Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale) | 3 months post-discharge | 2.78 score on a scale |
Primary
Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)
Differences in the number of caregivers who saw a support services specialist were compared between both groups using Chi-squared and Fisher's exact test.
Time frame: Outcomes are measured at discharge, 1 month, and 3 months post-discharge.
Population: Due to attrition in the study, the number of family caregivers assessed at discharge differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (MSM Intervention) | Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory) | Discharge | 8 Participants |
| Group I (MSM Intervention) | Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory) | 1 month post-discharge | 2 Participants |
| Group I (MSM Intervention) | Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory) | 3 months post-discharge | 0 Participants |
| Group II (Attention Control) | Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory) | Discharge | 5 Participants |
| Group II (Attention Control) | Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory) | 1 month post-discharge | 0 Participants |
| Group II (Attention Control) | Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory) | 3 months post-discharge | 2 Participants |
Primary
Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions)
Differences in the number of patients who were readmitted to the hospital for an overnight stay were compared between both groups using Chi-squared and Fisher's exact test.
Time frame: Outcomes are measured at 1 month, and 3 months post-discharge.
Population: Due to attrition in the study, the number of patients assessed differed during follow-up timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (MSM Intervention) | Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions) | 1 month post-discharge | 4 Participants |
| Group I (MSM Intervention) | Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions) | 3 months post-discharge | 7 Participants |
| Group II (Attention Control) | Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions) | 1 month post-discharge | 2 Participants |
| Group II (Attention Control) | Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions) | 3 months post-discharge | 8 Participants |
Secondary
Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)
Mean caregiver activation scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in activation between the intervention and control arm over time. Score range: 10-60. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool) | Baseline | 46.33 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool) | 1 month post-discharge | 48.50 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool) | 3 months post-discharge | 47.79 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool) | Baseline | 47.30 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool) | 1 month post-discharge | 48.76 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool) | 3 months post-discharge | 48.37 score on a scale |
Secondary
Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool)
Mean family caregiver knowledge scores from baseline to 3 months post-discharge were calculated. T-tests were used to assess differences in knowledge between the intervention and control arm at different timepoints. Score range: 0-10. Mean: 8.24 with a standard deviation of 1.19. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge
Population: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I (MSM Intervention) | Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool) | Baseline | 8.00 T-score | Standard Deviation 1.16 |
| Group I (MSM Intervention) | Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 1 month post-discharge | 8.76 T-score | Standard Deviation 0.85 |
| Group I (MSM Intervention) | Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 3 months post-discharge | 8.69 T-score | Standard Deviation 0.91 |
| Group II (Attention Control) | Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 3 months post-discharge | 8.15 T-score | Standard Deviation 1.26 |
| Group II (Attention Control) | Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool) | Baseline | 7.64 T-score | Standard Deviation 1.42 |
| Group II (Attention Control) | Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 1 month post-discharge | 8.45 T-score | Standard Deviation 0.91 |
Secondary
Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)
Mean caregiver self-efficacy scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in self-efficacy between the intervention and control arm over time. Score range: 1-4. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of family caregivers assessed at baseline differs from the number of family caregivers analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale) | Baseline | 3.33 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale) | 1 month post-discharge | 3.47 score on a scale |
| Group I (MSM Intervention) | Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale) | 3 months post-discharge | 3.52 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale) | Baseline | 3.33 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale) | 1 month post-discharge | 3.38 score on a scale |
| Group II (Attention Control) | Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale) | 3 months post-discharge | 3.40 score on a scale |
Secondary
Change in Patient Activation (as Measured by the Patient Activation Measure)
Mean patient activation scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in activation between the intervention and control arm over time. Score range: 0-100. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Patient Activation (as Measured by the Patient Activation Measure) | Baseline | 73.30 score on a scale |
| Group I (MSM Intervention) | Change in Patient Activation (as Measured by the Patient Activation Measure) | 1 month post-discharge | 75.41 score on a scale |
| Group I (MSM Intervention) | Change in Patient Activation (as Measured by the Patient Activation Measure) | 3 months post-discharge | 74.47 score on a scale |
| Group II (Attention Control) | Change in Patient Activation (as Measured by the Patient Activation Measure) | Baseline | 71.51 score on a scale |
| Group II (Attention Control) | Change in Patient Activation (as Measured by the Patient Activation Measure) | 1 month post-discharge | 71.00 score on a scale |
| Group II (Attention Control) | Change in Patient Activation (as Measured by the Patient Activation Measure) | 3 months post-discharge | 72.38 score on a scale |
Secondary
Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)
Mean patient knowledge scores from baseline to 3 months post-discharge were calculated. T-tests were used to assess differences in knowledge between the intervention and control arm at different timepoints. Score range: 0-10. Mean: 8.42 with a standard deviation of 1.16. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge
Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I (MSM Intervention) | Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool) | Baseline | 7.98 T-score | Standard Deviation 1.25 |
| Group I (MSM Intervention) | Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 1 month post-discharge | 9.00 T-score | Standard Deviation 1.18 |
| Group I (MSM Intervention) | Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 3 months post-discharge | 8.82 T-score | Standard Deviation 1 |
| Group II (Attention Control) | Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool) | Baseline | 7.98 T-score | Standard Deviation 1.03 |
| Group II (Attention Control) | Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 1 month post-discharge | 8.48 T-score | Standard Deviation 1.11 |
| Group II (Attention Control) | Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool) | 3 months post-discharge | 8.50 T-score | Standard Deviation 0.9 |
Secondary
Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)
Mean patient self-efficacy scores from baseline to 3 months post-discharge were calculated. A linear mixed-effects model was used to assess differences in self-efficacy between the intervention and control arm over time. Score range: 1-4. Higher score means better outcome.
Time frame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Population: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group I (MSM Intervention) | Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale) | Baseline | 3.60 score on a scale |
| Group I (MSM Intervention) | Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale) | 1 month post-discharge | 3.60 score on a scale |
| Group I (MSM Intervention) | Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale) | 3 months post-discharge | 3.56 score on a scale |
| Group II (Attention Control) | Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale) | Baseline | 3.51 score on a scale |
| Group II (Attention Control) | Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale) | 1 month post-discharge | 3.52 score on a scale |
| Group II (Attention Control) | Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale) | 3 months post-discharge | 3.55 score on a scale |