This pilot clinical trial studies how well the Enhancing Connections program improves family adjustment in patients with incurable cancer. Participating in an educational program with a co-parent to learn about ways to talk to a child about cancer may help parents and co-parents support their child with the parent's cancer and may help families communicate and function better.
PRIMARY OBJECTIVES: I. Test the feasibility of the study protocol in advanced cancer patients and co-parents (recruitment/retention, dosage and fidelity of the intervention; program acceptability of program; and logistics). II. Evaluate the short-term impact of the program on the diagnosed parents', co-parents' and children's adjustment and family functioning using a within group design (pre- and posttest design). III. Compare outcomes from the Enhancing Connections Palliative Program with similar outcomes obtained from the completed phase III trial (between group design) for the patients and children outcomes. IV. Evaluate the longer term impact of the program on the co-parents' and children's adjustment, including bereavement outcomes when appropriate, using a within and across group design (pre- and posttest design). OUTLINE: Patients and co-parents participate in the Enhancing Connections program consisting of 5 sessions over 1 hour each in the clinic or over the telephone. Session topics include managing cancer-related emotions when talking to children, developing deep listening skills, initiating difficult cancer-related conversations with children, interpreting a child's behavior, recognizing newly acquired gains from the program, and identifying available resources that can be used after program completion. After completion of the study, participants are followed-up at 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Complete Enhancing Connections program
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Feasibility of the Enhancing Connections program in advanced cancer patients and co-parents
Recruitment and retention of all triads will be monitored. Dosage and fidelity will be monitored for each intervention session. Program acceptability (per session, overall, duration of program, interval between intervention sessions) will be assessed from a debriefing interview. For logistics four areas will be monitored: rate of receipt of mailed materials both to participants and from participants; duration and type (whether telephone or in-person) of intervention sessions; rate of success in scheduling and completing intervention sessions with patient and co-parent; and quality of data on baseline, post-intervention and follow-up measures.
Time frame: Up to 2 years
Change in adjustment and family functioning
Descriptive statistics (e.g. means, medians) will be used to describe the Enhancing Connections palliative care population. Parents', co-parents and children's baseline scores \[parent-reported\] on standardized questionnaires will be compared with post-intervention and 6 month follow-up scores on the same measures.
Time frame: Baseline to 6 months
Outcomes from the Enhancing Connections Palliative Program as measured by the Child Behavior Check List
Linear mixed modeling based on Maximum Likelihood Estimation will be used to test the differences between the Child Behavior Check List results for the Enhancing Connections Palliative Program and the completed phase III trial (EC-R01).
Time frame: Up to 2 years
Change in adjustment as measured by post-traumatic growth scores
Enhancing Connection Palliative Program parents', co-parents' and children's post-traumatic growth scores will be compared with follow-up (6 month) scores on the same measure.
Time frame: Baseline to 6 months
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