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

University of Washington41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Advanced Malignant Neoplasm

Interventions

Educational InterventionOTHER

Receive Enhancing Connections Program

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Up to 3 months

Duration of intervention sessions

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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