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NCT Number: NCT02650583

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

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Key information

Conditions

Advanced Malignant Neoplasm

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive Enhancing Connections Program

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention

    Time frame: 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.

  2. Differences between the telephone-delivered and the in-person delivered program

    Time frame: 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.

  3. Dosage and fidelity

    Time frame: 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

  4. Duration of intervention sessions

    Time frame: Up to 3 months

  5. Number of patients recruited and retained, tracked on recruitment spreadsheets

    Time frame: Up to 3 months

    Three methods of recruitment will be monitored: self-referral, provider referral, and recruitment letter.

  6. Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire

    Time frame: Up to 3 months

    Will be compared with outcomes obtained from the intervention group in the EC-RCT (historical comparison group).

  7. Percentage of participants who complete both baseline and post-intervention sets of questionnaires with no missing data

    Time frame: Up to 3 months

    Assessed at baseline and post-intervention (up to 3 months).

  8. Percentage of participants who return both baseline and post-intervention sets of questionnaires within 2 weeks of receipt

    Time frame: Up to 14 weeks

    Assessed at baseline and post-intervention (up to 3 months).

  9. Program acceptability (per session, overall, duration of program, interval between intervention sessions)

    Time frame: 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.

  10. Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials)

    Time frame: Baseline

  11. Rate of success in scheduling and completing intervention sessions

    Time frame: At Session 5, occurring within up to 3 months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2016
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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