Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment

To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 4 and 12 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05.

If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in psychological distress (Psychological Distress Thermometer scores), at 4 and 12-week between the PCI and control groups, controlling for baseline psychological distress.

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in satisfaction (Family Satisfaction with Advanced Cancer Care scores), at 4 and 12-week between the PCI and control groups, controlling for baseline satisfaction.

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in symptom intensity and symptom interference with daily activities (using Psychological Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO - CTCAE) scores), at 4 and 12-week between the PCI and control groups, controlling for baseline symptom intensity and symptom interference.

Contingency table analysis and the chi square statistic will be used to examine the association between group and referral to various support services. In addition, total number of referrals will be counted and an independent student's t-test will be used to test for significant differences in number of total referrals between groups.

Total number of encounters and admissions will be counted and an independent student's t-test for each variable will be used to test for significant differences in number of total encounters and number of unscheduled admissions between groups.

Contingency table analysis with the chi square statistic to examine the association between group and hospice referral.

Contingency table analysis with the chi square statistic to examine the association between group and Phase I trial retention.

Descriptive statistics and comparisons between the two groups will be conducted for overall satisfaction with intervention content and timing of the intervention.

To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 4 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05.

If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).

To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 24 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05.

If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in psychological distress (Psychological Distress Thermometer scores), at 4 weeks, between the PCI and control groups, controlling for baseline psychological distress.

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in psychological distress (Psychological Distress Thermometer scores), at 24 weeks, between the PCI and control groups, controlling for baseline psychological distress.

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in satisfaction (Family Satisfaction with Advanced Cancer Care scores), at 4 weeks, between the PCI and control groups, controlling for baseline satisfaction.

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in satisfaction (Family Satisfaction with Advanced Cancer Care scores), up to 24 weeks, between the PCI and control groups, controlling for baseline satisfaction.

Analyzed using a 2x2 repeated measures ANCOVA to test for differences in symptom intensity and symptom interference with daily activities (Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO - CTCAE) scores), up to 24 weeks, between the PCI and control groups, controlling for baseline satisfaction.

Contingency table analysis and the chi square statistic will be used to examine the association between group and referral to various support services for up to 24 weeks. In addition, total number of referrals will be counted and an independent student's t-test will be used to test for significant differences in number of total referrals between groups.

Total number of encounters and admissions will be counted and an independent student's t-test for each variable will be used to test for significant differences in number of total encounters and number of unscheduled admissions between groups for up to 24 weeks.

Contingency table analysis with the chi square statistic to examine the association between group and hospice referral for up to 24 weeks.

Contingency table analysis with the chi square statistic to examine the association between group and Phase I trial retention for up to 24 weeks.

Descriptive statistics and comparisons between the two groups will be conducted for overall satisfaction with intervention content and timing of the intervention for up to 24 weeks.