Clinical trial NCT02650583: Enhancing Connections Program in Improving Communication Between Patients With Incurable Cancer and Their Children
Official title: Enhancing Connections Program in Palliative Care: Taking Care of the Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Malignant Neoplasm
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-01-08
Enrollment: 41
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in EC-palliative care (PC) parents' and children's scores (parent-reported) on standardized questionnaires from baseline to post-intervention
timeFrame: Baseline to up to 3 months
measure: Differences between the telephone-delivered and the in-person delivered program
timeFrame: Up to 3 months
measure: Dosage and fidelity
timeFrame: Up to 3 months
measure: Duration of intervention sessions
timeFrame: Up to 3 months
measure: Number of patients recruited and retained, tracked on recruitment spreadsheets
timeFrame: Up to 3 months
measure: Parent and child adjustment at completion of the EC-PC program, as measured by standardized questionnaire
timeFrame: Up to 3 months
measure: Percentage of participants who complete both baseline and post-intervention sets of questionnaires with no missing data
timeFrame: Up to 3 months
measure: Percentage of participants who return both baseline and post-intervention sets of questionnaires within 2 weeks of receipt
timeFrame: Up to 14 weeks
measure: Program acceptability (per session, overall, duration of program, interval between intervention sessions)
timeFrame: At Session 5, occurring within up to 3 months
measure: Rate of receipt of mailed materials both to participants and from participants (e.g., signed consents, baseline data; parent's materials)
timeFrame: Baseline
measure: Rate of success in scheduling and completing intervention sessions
timeFrame: At Session 5, occurring within up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Frances Lewis
role: PRINCIPAL_INVESTIGATOR
References: