Telephone-Based Educational Intervention in Improving Communication Between Patients With Stage 0-III Cancer and Their Children

Enhancing Connections Telephone Program: A Cancer Education Program for Parents

This pilot clinical trial studies the feasibility of a telephone-based educational intervention in improving communication between patients with stage 0-III cancer and their children. An educational program delivered by telephone may help parents talk with their school-age child about their cancer.

Study Overview

• Status: Completed
• Conditions: Melanoma; Lymphoma; Cervical Cancer; Leukemia; Breast Cancer; Rectal Cancer; Colon Cancer; Malignant Neoplasm
• Intervention / Treatment: Other: questionnaire administration; Other: educational intervention; Behavioral: telephone-based intervention

Detailed Description

PRIMARY OBJECTIVES:

I. Test the feasibility of the recruitment and study protocol.

II. Evaluate the short-term impact of the program on the diagnosed parents' and the parent's perceptions of their children's adjustment using a within group design (pre-posttest design).

III. To compare outcomes from the telephone-delivered program with outcomes obtained from the in-person program (between group design).

OUTLINE:

Participants complete the Enhancing Connections Telephone Program comprising 5, 1 hour educational telephone sessions over 3 months. During session 1, parents receive help defining the child's experience with the cancer as distinct from their own and ways to manage their own cancer-related emotions so that they do not emotionally flood the child. During session 2, parents receive assistance with developing skills to deeply listen and attend to the child's thoughts and feelings, complementing the parent's tendency to be a teacher, not a deep listener, of the child's thoughts, concerns, worries or understandings. During session 3, parents receive additional communication and parenting skills enabling them to initiate difficult cancer-related conversations and also interact with an upset child or one who is not forthcoming. During session 4, parents receive help focusing on and non-judgmentally interpreting the child's ways of coping with the cancer. It includes exercises that assist the parent to relinquish negative assumptions about the child's behavior related to the parent's cancer. Concurrently the session offers the ill parent ways to elicit their child's report of what the parent can do to assist the child cope with the child's cancer-related pressures. During session 5, parents focus on the gains they made in prior sessions and what they have accomplished, in their own words, in parenting their child about the cancer. The session also assists the ill parent to identify available resources that can be used after program completion to maintain the parent's newly acquired gains from the program.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59715
      • Bozeman Deaconess Hospital
  • Washington
    • Kennewick, Washington, United States, 99336
      • Columbia Basin Hematology and Oncology PLLC
    • Kennewick, Washington, United States, 99336
      • Tri-Cities Cancer Center
    • Kirkland, Washington, United States, 98033
      • SCCA at EvergreenHealth
    • Mount Vernon, Washington, United States, 98274
      • Skagit Valley Hospital
    • Port Angeles, Washington, United States, 98362
      • Olympic Medical Center
    • Redmond, Washington, United States, 98052
      • Group Health Cooperative
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    • Seattle, Washington, United States, 98122-4307
      • Swedish Cancer Institute
    • Tacoma, Washington, United States, 98415
      • MultiCare Health System
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents will be eligible if they have an initial diagnosis of non-metastatic cancer of any type (stage 0-3), including melanoma, colorectal, cervical, leukemia, lymphoma or breast cancer within the past 7 months
• Read and write English among their languages of choice
• Have ready access to a telephone
• Have a child 5-12 years old living at home who has been told their parent's cancer diagnosis
• The child is living at home and does not have learning challenges
• No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (Enhancing Connections Telephone Program); See Detailed Description.	Other: questionnaire administration; Ancillary studies; Other: educational intervention; Participate in the Enhancing Connections Telephone Program; Other Names: intervention, educational; Behavioral: telephone-based intervention; Participate in the Enhancing Connections Telephone Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment and retention, monitored by tracking detailed recruitment spreadsheets	Each referral source and method of referral will be monitored, including documenting reason for refusal. Four methods of recruitment will be monitored in order to know which method yields the highest enrollment: self-referral, provider referral, passive letter opt-in, and passive letter opt-out.	Up to 3 months
Dosage and fidelity, monitored for each intervention session using Performance Checklists	Each audio-recorded intervention session will be reviewed against these checklists. Study participants' compliance with the in-session and at-home assignments will be monitored by the audio-recorded intervention sessions.	Up to 3 months
Acceptability of the program, assessed from interview data obtained from the Exit interview and the Swanson Caring Professional Scale		Up to 3 months
Rate of receipt of mailed materials both to participants and from participants	Materials include signed consents, baseline data, and parent's educational materials.	Up to 3 months
Duration of phone intervention sessions		Up to 3 months
Rate of success in scheduling and completing intervention sessions by telephone		Up to 3 months
Quality of data on baseline and post-intervention measures		Up to 3 months
Short-term impact of the program, evaluated by comparing the change in pre- and post-test scores on the standardized questionnaires	Analysis of covariance (ANCOVA) will be used to test for significant differences between pre- and post-test scores, assuming the data meet the statistical assumptions. Baseline scores will serve as the covariate, along with empirical variables that are known to co-vary with parent and child functioning, e.g., length of time of diagnosis, type of medical treatment, adjuvant therapy, among others). Two-tailed tests of significance will be calculated, allowing us to evaluate any potential negative effects of the intervention.	Baseline up to 3 months
Impact of the telephone-delivered compared to the in-person delivered program	Linear mixed modeling will be used. Random effects models are based on Maximum Likelihood Estimation in which an iterative method estimates a trajectory for each study participant based on all available data for that participant supplemented by data obtained from the total sample.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Frances Lewis, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 2, 2014

Study Record Updates

• Last Update Posted (Estimate): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 9095 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2014-00928 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R03CA178488 (U.S. NIH Grant/Contract)