Trial Outcomes & Findings for Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients (NCT NCT03686007)
NCT ID: NCT03686007
Last Updated: 2025-04-27
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
380 participants
Primary outcome timeframe
Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
Results posted on
2025-04-27
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
192
|
|
Overall Study
COMPLETED
|
156
|
155
|
|
Overall Study
NOT COMPLETED
|
32
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants.
Baseline characteristics by cohort
| Measure |
Group I (MSM Intervention)
n=188 Participants
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
|
Group II (Attention Control)
n=192 Participants
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
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=188 Participants
|
65.0 years
n=192 Participants
|
66.0 years
n=380 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=187 Participants • Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants.
|
116 Participants
n=192 Participants • Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants.
|
226 Participants
n=379 Participants • Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants.
|
|
Sex: Female, Male
Male
|
77 Participants
n=187 Participants • Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants.
|
76 Participants
n=192 Participants • Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants.
|
153 Participants
n=379 Participants • Due to missing item responses and no separate category for "Unknown" sex, the number of participants analyzed differs from the overall number of participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=188 Participants
|
21 Participants
n=192 Participants
|
48 Participants
n=380 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=188 Participants
|
166 Participants
n=192 Participants
|
319 Participants
n=380 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=188 Participants
|
5 Participants
n=192 Participants
|
13 Participants
n=380 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=188 Participants
|
0 Participants
n=192 Participants
|
1 Participants
n=380 Participants
|
|
Race (NIH/OMB)
Asian
|
42 Participants
n=188 Participants
|
43 Participants
n=192 Participants
|
85 Participants
n=380 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=188 Participants
|
1 Participants
n=192 Participants
|
2 Participants
n=380 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=188 Participants
|
8 Participants
n=192 Participants
|
12 Participants
n=380 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=188 Participants
|
118 Participants
n=192 Participants
|
244 Participants
n=380 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=188 Participants
|
6 Participants
n=192 Participants
|
7 Participants
n=380 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=188 Participants
|
16 Participants
n=192 Participants
|
29 Participants
n=380 Participants
|
|
Region of Enrollment
United States
|
188 participants
n=188 Participants
|
192 participants
n=192 Participants
|
380 participants
n=380 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=92 Participants
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
|
Group II (Attention Control)
n=96 Participants
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
|
|---|---|---|
|
Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
Baseline
|
3.92 score on a scale
Interval 3.38 to 4.47
|
4.19 score on a scale
Interval 3.65 to 4.72
|
|
Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
1 month post-discharge
|
3.38 score on a scale
Interval 2.79 to 3.98
|
3.74 score on a scale
Interval 3.12 to 4.36
|
|
Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
3 months post-discharge
|
3.22 score on a scale
Interval 2.62 to 3.82
|
4.14 score on a scale
Interval 3.54 to 4.74
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=93 Participants
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
|
Group II (Attention Control)
n=95 Participants
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
|
|---|---|---|
|
Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)
Baseline
|
44.68 score on a scale
Interval 43.01 to 46.35
|
44.56 score on a scale
Interval 42.91 to 46.21
|
|
Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)
1 month post-discharge
|
42.19 score on a scale
Interval 40.36 to 44.02
|
44.73 score on a scale
Interval 42.83 to 46.63
|
|
Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)
3 months post-discharge
|
40.45 score on a scale
Interval 38.63 to 42.27
|
42.00 score on a scale
Interval 40.18 to 43.82
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=93 Participants
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
|
Group II (Attention Control)
n=95 Participants
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
|
|---|---|---|
|
Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)
Baseline
|
2.55 score on a scale
Interval 2.38 to 2.72
|
2.60 score on a scale
Interval 2.44 to 2.77
|
|
Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)
1 month post-discharge
|
2.98 score on a scale
Interval 2.8 to 3.16
|
2.88 score on a scale
Interval 2.7 to 3.07
|
|
Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)
3 months post-discharge
|
2.94 score on a scale
Interval 2.76 to 3.12
|
2.78 score on a scale
Interval 2.6 to 2.96
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=93 Participants
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
|
Group II (Attention Control)
n=94 Participants
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
|
|---|---|---|
|
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
Interval 26.45 to 28.94
|
26.67 score on a scale
Interval 25.4 to 27.94
|
|
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
Interval 26.27 to 28.76
|
26.43 score on a scale
Interval 25.2 to 27.67
|
|
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
Interval 25.85 to 28.22
|
26.83 score on a scale
Interval 25.65 to 28.01
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=90 Participants
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
|
Group II (Attention Control)
n=94 Participants
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
|
|---|---|---|
|
Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)
3 months post-discharge
|
0 Participants
|
2 Participants
|
|
Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)
Discharge
|
8 Participants
|
5 Participants
|
|
Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)
1 month post-discharge
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=94 Participants
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
|
Group II (Attention Control)
n=96 Participants
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
|
|---|---|---|
|
Change in Patient Psychological Distress (as Measured by the Distress Thermometer)
Baseline
|
4.23 score on a scale
Interval 3.6 to 4.8
|
4.39 score on a scale
Interval 3.8 to 5.0
|
|
Change in Patient Psychological Distress (as Measured by the Distress Thermometer)
1 month post-discharge
|
3.42 score on a scale
Interval 2.8 to 4.1
|
3.55 score on a scale
Interval 2.9 to 4.2
|
|
Change in Patient Psychological Distress (as Measured by the Distress Thermometer)
3 months post-discharge
|
3.25 score on a scale
Interval 2.6 to 3.9
|
3.76 score on a scale
Interval 3.1 to 4.4
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=93 Participants
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
|
Group II (Attention Control)
n=94 Participants
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
|
|---|---|---|
|
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
Interval 102.2 to 109.9
|
104.27 score on a scale
Interval 100.4 to 108.1
|
|
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
Interval 99.8 to 108.1
|
99.17 score on a scale
Interval 94.9 to 103.5
|
|
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
Interval 99.5 to 107.6
|
101.04 score on a scale
Interval 96.9 to 105.2
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=90 Participants
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
|
Group II (Attention Control)
n=90 Participants
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
|
|---|---|---|
|
Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions)
1 month post-discharge
|
4 Participants
|
2 Participants
|
|
Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions)
3 months post-discharge
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=92 Participants
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
|
Group II (Attention Control)
n=93 Participants
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
|
|---|---|---|
|
Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)
Baseline
|
3.33 score on a scale
Interval 3.22 to 3.44
|
3.33 score on a scale
Interval 3.22 to 3.44
|
|
Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)
1 month post-discharge
|
3.47 score on a scale
Interval 3.35 to 3.59
|
3.38 score on a scale
Interval 3.25 to 3.5
|
|
Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)
3 months post-discharge
|
3.52 score on a scale
Interval 3.41 to 3.64
|
3.40 score on a scale
Interval 3.28 to 3.52
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=94 Participants
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
|
Group II (Attention Control)
n=94 Participants
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
|
|---|---|---|
|
Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)
Baseline
|
3.60 score on a scale
Interval 3.5 to 3.7
|
3.51 score on a scale
Interval 3.4 to 3.6
|
|
Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)
1 month post-discharge
|
3.60 score on a scale
Interval 3.5 to 3.7
|
3.52 score on a scale
Interval 3.4 to 3.6
|
|
Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)
3 months post-discharge
|
3.56 score on a scale
Interval 3.5 to 3.7
|
3.55 score on a scale
Interval 3.4 to 3.7
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=93 Participants
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
|
Group II (Attention Control)
n=93 Participants
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
|
|---|---|---|
|
Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)
Baseline
|
46.33 score on a scale
Interval 44.3 to 48.37
|
47.30 score on a scale
Interval 45.27 to 49.33
|
|
Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)
3 months post-discharge
|
47.79 score on a scale
Interval 45.62 to 49.96
|
48.37 score on a scale
Interval 46.22 to 50.53
|
|
Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)
1 month post-discharge
|
48.50 score on a scale
Interval 46.34 to 50.67
|
48.76 score on a scale
Interval 46.54 to 50.99
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=94 Participants
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
|
Group II (Attention Control)
n=95 Participants
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
|
|---|---|---|
|
Change in Patient Activation (as Measured by the Patient Activation Measure)
Baseline
|
73.30 score on a scale
Interval 69.7 to 76.9
|
71.51 score on a scale
Interval 67.9 to 75.1
|
|
Change in Patient Activation (as Measured by the Patient Activation Measure)
1 month post-discharge
|
75.41 score on a scale
Interval 71.6 to 79.3
|
71.00 score on a scale
Interval 67.0 to 75.0
|
|
Change in Patient Activation (as Measured by the Patient Activation Measure)
3 months post-discharge
|
74.47 score on a scale
Interval 70.7 to 78.3
|
72.38 score on a scale
Interval 68.5 to 76.3
|
SECONDARY outcome
Timeframe: Outcomes are measured at baseline, 1 month, and 3 months post-dischargePopulation: 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.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=94 Participants
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
|
Group II (Attention Control)
n=96 Participants
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
|
|---|---|---|
|
Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool)
Baseline
|
8.00 T-score
Standard Deviation 1.16
|
7.64 T-score
Standard Deviation 1.42
|
|
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
|
8.45 T-score
Standard Deviation 0.91
|
|
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
|
8.15 T-score
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Outcomes are measured at baseline, 1 month, and 3 months post-dischargePopulation: Due to attrition in the study, the number of patients assessed at baseline differs from the number of patients analyzed during follow-up.
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.
Outcome measures
| Measure |
Group I (MSM Intervention)
n=94 Participants
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
|
Group II (Attention Control)
n=96 Participants
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
|
|---|---|---|
|
Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)
Baseline
|
7.98 T-score
Standard Deviation 1.25
|
7.98 T-score
Standard Deviation 1.03
|
|
Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)
1 month post-discharge
|
9.00 T-score
Standard Deviation 1.18
|
8.48 T-score
Standard Deviation 1.11
|
|
Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)
3 months post-discharge
|
8.82 T-score
Standard Deviation 1.00
|
8.50 T-score
Standard Deviation 0.90
|
Adverse Events
Group I (MSM Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Group II (Attention Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place