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

NCT ID: NCT02129049

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Cervical Cancer Colon Cancer Leukemia Lymphoma Malignant Neoplasm Melanoma Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (Enhancing Connections Telephone Program)

See Detailed Description.

Group Type EXPERIMENTAL

educational intervention

Intervention Type OTHER

Participate in the Enhancing Connections Telephone Program

telephone-based intervention

Intervention Type BEHAVIORAL

Participate in the Enhancing Connections Telephone Program

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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educational intervention

Participate in the Enhancing Connections Telephone Program

Intervention Type OTHER

telephone-based intervention

Participate in the Enhancing Connections Telephone Program

Intervention Type BEHAVIORAL

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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intervention, educational

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frances Lewis

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

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Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Columbia Basin Hematology and Oncology PLLC

Kennewick, Washington, United States

Site Status

Tri-Cities Cancer Center

Kennewick, Washington, United States

Site Status

SCCA at EvergreenHealth

Kirkland, Washington, United States

Site Status

Skagit Valley Hospital

Mount Vernon, Washington, United States

Site Status

Olympic Medical Center

Port Angeles, Washington, United States

Site Status

Group Health Cooperative

Redmond, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Multicare Health System

Tacoma, Washington, United States

Site Status

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2014-00928

Identifier Type: REGISTRY

Identifier Source: secondary_id

9095

Identifier Type: OTHER

Identifier Source: secondary_id

R03CA178488

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9095

Identifier Type: -

Identifier Source: org_study_id

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