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Trial record 17 of 21 for:    Recruiting, Not yet recruiting, Available Studies | "Bereavement"

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

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ClinicalTrials.gov Identifier: NCT03049397
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Other: Communication Intervention Other: Questionnaire Administration Not Applicable

Detailed Description:

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  (Clinical Trial)
Estimated Enrollment : 99 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Family Functioning and Bereavement Outcomes Following the Enhancing Connections Program in Palliative Care
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2021

Arm Intervention/treatment
Experimental: Supportive Care (Enhancing Connections program)
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
Complete Enhancing Connections program

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Feasibility of the Enhancing Connections program in advanced cancer patients and co-parents [ Time Frame: Up to 2 years ]
    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.

  2. Change in adjustment and family functioning [ Time Frame: Baseline to 6 months ]
    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.

  3. Outcomes from the Enhancing Connections Palliative Program as measured by the Child Behavior Check List [ Time Frame: Up to 2 years ]
    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).

  4. Change in adjustment as measured by post-traumatic growth scores [ Time Frame: Baseline to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

ALL PARTICIPANTS

  • Participants must live within 35 miles of the University of Washington, Seattle, WA to receive the in-person version of the intervention
  • Parents and co-parents selecting the telephone version of the intervention may live any distance from the University of Washington

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049397


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Elizabeth Loggers    206-667-7442    eloggers@seattlecca.org   
Principal Investigator: Elizabeth Loggers         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth Loggers Fred Hutch/University of Washington Cancer Consortium

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03049397     History of Changes
Other Study ID Numbers: 9667
NCI-2016-01640 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9667 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms