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.
Other: educational intervention
Behavioral: telephone-based intervention
Other: questionnaire administration
|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|
- 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.
|Study Start Date:||April 2014|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (Enhancing Connections Telephone Program)
See Detailed Description.
Other: educational intervention
Participate in the Enhancing Connections Telephone Program
Other Name: intervention, educationalBehavioral: telephone-based intervention
Participate in the Enhancing Connections Telephone ProgramOther: questionnaire administration
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02129049
|United States, Montana|
|Bozeman Deaconess Hospital||Recruiting|
|Bozeman, Montana, United States, 59715|
|Contact: Jack Hensold 406-585-5070|
|Principal Investigator: Jack Hensold|
|United States, Washington|
|Tri-Cities Cancer Center||Recruiting|
|Kennewick, Washington, United States, 99336|
|Contact: Sue Mandell 509-737-3371|
|Principal Investigator: Sue Mandell|
|Columbia Basin Hematology and Oncology PLLC||Recruiting|
|Kennewick, Washington, United States, 99336|
|Contact: Thomas Rado 509-783-0144|
|Principal Investigator: Thomas Rado|
|SCCA at EvergreenHealth||Recruiting|
|Kirkland, Washington, United States, 98033|
|Contact: Aimee Kohn 425-899-3181|
|Principal Investigator: Aimee Kohn|
|Skagit Valley Hospital||Recruiting|
|Mount Vernon, Washington, United States, 98274|
|Contact: Kiarash Kojouri 360-428-2146|
|Principal Investigator: Kiarash Kojouri|
|Olympic Medical Center||Recruiting|
|Port Angeles, Washington, United States, 98362|
|Contact: Thomas Kummet 360-683-9895|
|Principal Investigator: Thomas Kummet|
|Group Health Cooperative||Recruiting|
|Redmond, Washington, United States, 98052|
|Contact: Eric Chen 425-502-3690|
|Principal Investigator: Eric Chen|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Frances Lewis 866-577-8062|
|Principal Investigator: Frances Lewis|
|Swedish Cancer Institute||Recruiting|
|Seattle, Washington, United States, 98122-4307|
|Contact: Patricia Dawson 206-320-4880|
|Principal Investigator: Patricia Dawson|
|Multicare Health System||Recruiting|
|Tacoma, Washington, United States, 98415|
|Contact: Troy Wadsworth 253-403-1677|
|Principal Investigator: Troy Wadsworth|
|Wenatchee Valley Medical Center||Recruiting|
|Wenatchee, Washington, United States, 98801|
|Contact: Mitchell Garrison 509-665-5800|
|Principal Investigator: Mitchell Garrison|
|Principal Investigator:||Frances Lewis||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|