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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01941 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9480 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies the use of the Enhancing Connections Program in improving communication between patients with incurable cancer and their children. The Enhancing Connections Program is an educational program that may provide patients with new competencies to improve communication with their children and help them to cope with their parent's incurable cancer.
PRIMARY OBJECTIVES:
I. To test the feasibility of the study protocol in advanced cancer patients (recruitment/retention, dosage and fidelity of the intervention; program acceptability of program; and logistics).
II. To evaluate the short-term impact of the program on the diagnosed parents' and children's adjustment using a within group design (pre- and post-test design).
III. To compare outcomes from the Enhancing Connections Program with outcomes obtained from the completed Phase III trial (between group design).
OUTLINE:
Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (Enhancing Connections Program) | Experimental | Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive Enhancing Connections Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention | Baseline scores will be compared with post-intervention scores on the same measures. Analysis of covariance will be used to test for significant differences between pre- and post-test scores. | Baseline to up to 3 months |
| Differences between the telephone-delivered and the in-person delivered program | Linear mixed modeling based on maximum likelihood estimation will be used to test the differences between the telephone-delivered and the in-person delivered program. | Up to 3 months |
| Dosage and fidelity | Will be monitored for each intervention session using the performance checklists, the same checklists used to monitor dosage and fidelity in the Enhancing Connections (EC) trial. (Each session of the Program has its own unique Performance Checklist and each item is scored from 0-2. Performance Checklist items are specific to each session of the Program to be delivered by the patient educator. Higher scores denote higher performance by the patient educator and greater confidence that the Program was delivered as designed. The Performance Checklist is only used to monitor the performance of the | Up to 3 months |
| Duration of intervention sessions | Up to 3 months | |
| Number of patients recruited and retained, tracked on recruitment spreadsheets | Three methods of recruitment will be monitored: self-referral, provider referral, and recruitment letter. | Up to 3 months |
| Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Lewis | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Questionnaire Administration | Other | Ancillary studies |
|
Will be compared with outcomes obtained from the intervention group in the EC-RCT (historical comparison group). |
| Up to 3 months |
| Percentage of participants who complete both baseline and post-intervention sets of questionnaires with no missing data | Assessed at baseline and post-intervention (up to 3 months). | Up to 3 months |
| Percentage of participants who return both baseline and post-intervention sets of questionnaires within 2 weeks of receipt | Assessed at baseline and post-intervention (up to 3 months). | Up to 14 weeks |
| Program acceptability (per session, overall, duration of program, interval between intervention sessions) | Will be assessed from a debriefing interview in Session 5 that includes the parents' attributed gains of the program and their responses to the program's content, format, in-session, and at-home assignments. | At Session 5, occurring within up to 3 months |
| Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials) | Baseline |
| Rate of success in scheduling and completing intervention sessions | At Session 5, occurring within up to 3 months |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |