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

Breast Cancer Clinical Trial

Official title:

Enhancing Connections Telephone Program: A Cancer Education Program for Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129049
• Other study ID #: 9095
• Secondary ID: NCI-2014-0092890
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: March 8, 2016
• Start date: April 2014

Study information

• Verified date: March 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Colon Cancer
• Leukemia
• Lymphoma
• Malignant Neoplasm
• Melanoma
• Neoplasms
• Rectal Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• educational intervention
Participate in the Enhancing Connections Telephone Program

Behavioral:
• telephone-based intervention
Participate in the Enhancing Connections Telephone Program

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Columbia Basin Hematology and Oncology PLLC	Kennewick	Washington
United States	Tri-Cities Cancer Center	Kennewick	Washington
United States	SCCA at EvergreenHealth	Kirkland	Washington
United States	Skagit Valley Hospital	Mount Vernon	Washington
United States	Olympic Medical Center	Port Angeles	Washington
United States	Group Health Cooperative	Redmond	Washington
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Multicare Health System	Tacoma	Washington
United States	Wenatchee Valley Medical Center	Wenatchee	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Acceptability of the program, assessed from interview data obtained from the Exit interview and the Swanson Caring Professional Scale		Up to 3 months	No
Primary	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	No
Primary	Duration of phone intervention sessions		Up to 3 months	No
Primary	Rate of success in scheduling and completing intervention sessions by telephone		Up to 3 months	No
Primary	Quality of data on baseline and post-intervention measures		Up to 3 months	No
Primary	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	No
Primary	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	No