Enhancing Connections Program in Improving Family Adjustment in Patients With Incurable Cancer

NCT03049397 | Terminated DMC

• 4 other identifiers: 9667NCI-2016-01640P30CA015704RG9218011
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  Baseline to 6 months

Study Arms (1)

Supportive Care (Enhancing Connections program)

EXPERIMENTAL

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.

Other: Communication Intervention; Other: Questionnaire Administration

Interventions

Communication Intervention OTHER

Complete Enhancing Connections program

Supportive Care (Enhancing Connections program)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (Enhancing Connections program)

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PATIENTS
• Ages 25-65 years
• Have a diagnosis of incurable cancer of any type; at any time in the diagnosis as long as they have at least a 4 month life expectancy based on the opinion of the attending physician
• Read and write English among their languages of choice
• Parent must live at least 50% of the time in the home and have a child 5-17 years old living at home who has been told their parent's cancer diagnosis
• CO-PARENTS
• Co-parents must reside with the consenting eligible cancer participant (and child) at least 50% of the time and be actively participating in the care of the child
• If a biological parent lives in the home, and is physically well themselves, this person must be the co-parent
• If a biological parent does not live in the home (or has died), the co-parent does not have to be a biological parent; therefore, co-parents may be step-parents, lesbian, gay, bi-sexual or transgender (LGBT) partners, grandparents, aunts, uncles, etc if they otherwise meet eligibility criteria
• He or she can read and write English among their languages of choice and agrees to attend the patient intervention sessions in person or by telephone
• CHILDREN
• The patient and co-parent must agree to focus on the same child throughout the study and consent to have the child participate before the child's assent will be sought
• Children aged 5-13 years of age will participate with a waiver of assent
• Children aged 14-17 will assent to participate in the research study by signing a separate assent form
• Children of formal assenting age will be eligible to participate if they can read and write English among their languages of choice

You may not qualify if:

• Patients 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
• The triad will be ineligible if any member lives in the home less than 50% of the time
• If any member of the triad retracts consent or assent prior to completion of the post-intervention surveys, then all members will be excluded from the study thereafter
• The child will be excluded if he or she has learning challenges as assessed by the patient or co-parent; patients and co-parents will be instructed to consider any formal diagnoses of a learning disability of the presence of an Individual Education Plan (IEP) when making this assessment

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Study Officials

• Elizabeth Loggers

  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: February 8, 2017
• First Posted: February 10, 2017
• Study Start: April 5, 2017
• Primary Completion: September 12, 2018
• Study Completion: November 30, 2018
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

US (1)