Enhancing Connections Program in Improving Communication Between Patients With Incurable Cancer and Their Children

Advanced Malignant Neoplasm Clinical Trial

Official title:

Enhancing Connections Program in Palliative Care: Taking Care of the Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650583
• Other study ID #: 9480
• Secondary ID: NCI-2015-0194194
• Status: Completed
• Phase: N/A
• Start date: December 28, 2015
• Est. completion date: February 15, 2018

Study information

• Verified date: February 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Educational Intervention
Receive Enhancing Connections Program
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Duration of intervention sessions		Up to 3 months
Primary	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
Primary	Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire	Will be compared with outcomes obtained from the intervention group in the EC-RCT (historical comparison group).	Up to 3 months
Primary	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
Primary	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
Primary	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
Primary	Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials)		Baseline
Primary	Rate of success in scheduling and completing intervention sessions		At Session 5, occurring within up to 3 months