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

NCT02129049 | Completed DMC

• 4 other identifiers: 9095NCI-2014-00928R03CA178488P30CA015704
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Supportive care (Enhancing Connections Telephone Program)

EXPERIMENTAL

See Detailed Description.

Other: educational intervention; Behavioral: telephone-based intervention; Other: questionnaire administration

Interventions

educational intervention OTHER

Participate in the Enhancing Connections Telephone Program

Also known as: intervention, educational

Supportive care (Enhancing Connections Telephone Program)

telephone-based intervention BEHAVIORAL

Participate in the Enhancing Connections Telephone Program

Supportive care (Enhancing Connections Telephone Program)

questionnaire administration OTHER

Ancillary studies

Supportive care (Enhancing Connections Telephone Program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Columbia Basin Hematology and Oncology PLLC

Kennewick, Washington, 99336, United States

Location

Tri-Cities Cancer Center

Kennewick, Washington, 99336, United States

Location

SCCA at EvergreenHealth

Kirkland, Washington, 98033, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

Olympic Medical Center

Port Angeles, Washington, 98362, United States

Location

Group Health Cooperative

Redmond, Washington, 98052, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98122-4307, United States

Location

Multicare Health System

Tacoma, Washington, 98415, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms; Colonic Neoplasms; Leukemia; Lymphoma; Neoplasms; Melanoma; Rectal Neoplasms

Interventions

Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Rectal Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques

Study Officials

• Frances Lewis

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

US (11)