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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT02129049
First received: April 30, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Cervical Cancer
Colon Cancer
Leukemia
Lymphoma
Malignant Neoplasm
Melanoma
Rectal Cancer
Other: educational intervention
Behavioral: telephone-based intervention
Other: questionnaire administration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Enhancing Connections Telephone Program: A Cancer Education Program for Parents

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Recruitment and retention, monitored by tracking detailed recruitment spreadsheets [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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.

  • Dosage and fidelity, monitored for each intervention session using Performance Checklists [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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.

  • Acceptability of the program, assessed from interview data obtained from the Exit interview and the Swanson Caring Professional Scale [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Rate of receipt of mailed materials both to participants and from participants [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Materials include signed consents, baseline data, and parent's educational materials.

  • Duration of phone intervention sessions [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Rate of success in scheduling and completing intervention sessions by telephone [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Quality of data on baseline and post-intervention measures [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Short-term impact of the program, evaluated by comparing the change in pre- and post-test scores on the standardized questionnaires [ Time Frame: Baseline up to 3 months ] [ Designated as safety issue: No ]
    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.

  • Impact of the telephone-delivered compared to the in-person delivered program [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (Enhancing Connections Telephone Program)
See Detailed Description.
Other: educational intervention
Participate in the Enhancing Connections Telephone Program
Other Name: intervention, educational
Behavioral: telephone-based intervention
Participate in the Enhancing Connections Telephone Program
Other: questionnaire administration
Ancillary studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129049

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Frances Lewis    206-236-0482      
Principal Investigator: Frances Lewis         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Frances Lewis Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02129049     History of Changes
Other Study ID Numbers: 9095, NCI-2014-00928, 9095, R03CA178488, P30CA015704
Study First Received: April 30, 2014
Last Updated: April 30, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Uterine Cervical Neoplasms
Leukemia
Lymphoma
Melanoma
Neoplasms by Site
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

ClinicalTrials.gov processed this record on July 20, 2014