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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00928 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9095 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| R03CA178488 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (Enhancing Connections Telephone Program) | Experimental | See Detailed Description. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Participate in the Enhancing Connections Telephone Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Lewis | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | United States | ||
| Columbia Basin Hematology and Oncology PLLC |
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| telephone-based intervention | Behavioral | Participate in the Enhancing Connections Telephone Program |
|
| questionnaire administration | Other | Ancillary studies |
|
| 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 |
| Kennewick |
| Washington |
| 99336 |
| United States |
| Tri-Cities Cancer Center | Kennewick | Washington | 99336 | United States |
| SCCA at EvergreenHealth | Kirkland | Washington | 98033 | United States |
| Skagit Valley Hospital | Mount Vernon | Washington | 98274 | United States |
| Olympic Medical Center | Port Angeles | Washington | 98362 | United States |
| Group Health Cooperative | Redmond | Washington | 98052 | United States |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98122-4307 | United States |
| Multicare Health System | Tacoma | Washington | 98415 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D003110 | Colonic Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| D008545 | Melanoma |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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