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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (Enhancing Connections Program); 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.

Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Receive Enhancing Connections Program; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Frances Lewis, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2015
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 9480 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2015-01941 (Registry Identifier: CTRP (Clinical Trial Reporting Program))