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

NCT02650583 | Completed

• 3 other identifiers: 9480NCI-2015-01941P30CA015704
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

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.

Other: Educational Intervention; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Receive Enhancing Connections Program

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (Enhancing Connections Program)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (Enhancing Connections Program)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Frances Lewis

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: January 8, 2016
• Study Start: December 28, 2015
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)