Clinical trial NCT02129049: Telephone-Based Educational Intervention in Improving Communication Between Patients With Stage 0-III Cancer and Their Children
Official title: Enhancing Connections Telephone Program: A Cancer Education Program for Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Colon Cancer
Leukemia
Lymphoma
Malignant Neoplasm
Melanoma
Rectal Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and retention, monitored by tracking detailed recruitment spreadsheets
timeFrame: Up to 3 months
measure: Dosage and fidelity, monitored for each intervention session using Performance Checklists
timeFrame: Up to 3 months
measure: Acceptability of the program, assessed from interview data obtained from the Exit interview and the Swanson Caring Professional Scale
timeFrame: Up to 3 months
measure: Rate of receipt of mailed materials both to participants and from participants
timeFrame: Up to 3 months
measure: Duration of phone intervention sessions
timeFrame: Up to 3 months
measure: Rate of success in scheduling and completing intervention sessions by telephone
timeFrame: Up to 3 months
measure: Quality of data on baseline and post-intervention measures
timeFrame: Up to 3 months
measure: Short-term impact of the program, evaluated by comparing the change in pre- and post-test scores on the standardized questionnaires
timeFrame: Baseline up to 3 months
measure: Impact of the telephone-delivered compared to the in-person delivered program
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Bozeman Deaconess Hospital
state: Montana
city: Kennewick
country: United States
facility: Columbia Basin Hematology and Oncology PLLC
state: Washington
city: Kennewick
country: United States
facility: Tri-Cities Cancer Center
state: Washington
city: Kirkland
country: United States
facility: SCCA at EvergreenHealth
state: Washington
city: Mount Vernon
country: United States
facility: Skagit Valley Hospital
state: Washington
city: Port Angeles
country: United States
facility: Olympic Medical Center
state: Washington
city: Redmond
country: United States
facility: Group Health Cooperative
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Frances Lewis
role: PRINCIPAL_INVESTIGATOR
References: