An interventional study of educational intervention and telephone-based intervention in Breast Cancer, Cervical Cancer and Colon Cancer, sponsored by University of Washington. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-09.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
See Detailed Description.
Other: educational intervention · Behavioral: telephone-based intervention · Other: questionnaire administration
Participate in the Enhancing Connections Telephone Program
Also known as: intervention, educational
Participate in the Enhancing Connections Telephone Program
Ancillary studies
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.
Time frame: 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.
Time frame: Up to 3 months
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
Rate of receipt of mailed materials both to participants and from participants
Materials include signed consents, baseline data, and parent's educational materials.
Time frame: Up to 3 months
Duration of phone intervention sessions
Time frame: Up to 3 months
Rate of success in scheduling and completing intervention sessions by telephone
Time frame: Up to 3 months
Quality of data on baseline and post-intervention measures
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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