Enhancing Connections Program in Improving Communication Between Patients With Incurable Cancer and Their Children
- Conditions
- Advanced Malignant Neoplasm
- Interventions
- Other: Educational InterventionOther: Questionnaire Administration
- Registration Number
- NCT02650583
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Parents will be eligible if they have a diagnosis of incurable cancer of any type
- Read and write English among their languages of choice
- Have a child 5-17 years old living at home who has been told their parent's cancer diagnosis
- The child does not have learning challenges
- Parents will be excluded if they are enrolled in hospice at time of enrollment; (however, they will be allowed to continue in the study if they enroll in hospice after beginning the study)
- Parents will be ineligible if their child lives in the home less than 50% of the time
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive care (Enhancing Connections Program) Questionnaire Administration 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. Supportive care (Enhancing Connections Program) Educational Intervention 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.
- Primary Outcome Measures
Name Time Method Differences between the telephone-delivered and the in-person delivered program Up to 3 months 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.
Dosage and fidelity Up to 3 months 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
Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials) Baseline Number of patients recruited and retained, tracked on recruitment spreadsheets Up to 3 months Three methods of recruitment will be monitored: self-referral, provider referral, and recruitment letter.
Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire Up to 3 months Will be compared with outcomes obtained from the intervention group in the EC-RCT (historical comparison group).
Program acceptability (per session, overall, duration of program, interval between intervention sessions) At Session 5, occurring within up to 3 months 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.
Rate of success in scheduling and completing intervention sessions At Session 5, occurring within up to 3 months Percentage of participants who complete both baseline and post-intervention sets of questionnaires with no missing data Up to 3 months Assessed at baseline and post-intervention (up to 3 months).
Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention Baseline to up to 3 months 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.
Duration of intervention sessions Up to 3 months Percentage of participants who return both baseline and post-intervention sets of questionnaires within 2 weeks of receipt Up to 14 weeks Assessed at baseline and post-intervention (up to 3 months).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fred Hutch/University of Washington Cancer Consortium
🇺🇸Seattle, Washington, United States