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Completed

NCT Number: NCT02129049

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bozeman Deaconess Hospital, Bozeman, Montana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Participate in the Enhancing Connections Telephone Program

Other names: intervention, educational

Telephone-Based Intervention

Behavioral

Participate in the Enhancing Connections Telephone Program

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Recruitment and retention, monitored by tracking detailed recruitment spreadsheets

    Time frame: Up to 3 months

    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.

  2. Dosage and fidelity, monitored for each intervention session using Performance Checklists

    Time frame: Up to 3 months

    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.

  3. 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

  4. Rate of receipt of mailed materials both to participants and from participants

    Time frame: Up to 3 months

    Materials include signed consents, baseline data, and parent's educational materials.

  5. Duration of phone intervention sessions

    Time frame: Up to 3 months

  6. Rate of success in scheduling and completing intervention sessions by telephone

    Time frame: Up to 3 months

  7. Quality of data on baseline and post-intervention measures

    Time frame: Up to 3 months

  8. 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

    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.

  9. Impact of the telephone-delivered compared to the in-person delivered program

    Time frame: Up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Enhancing Connections Telephone Program: A Cancer Education Program for Parents

Important dates

Study start
2014
Primary completion
2015
First posted
May 2, 2014
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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