Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01NR019987-01A1 | U.S. NIH Grant/Contract | View source | |
| STUDY00011221 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2022-08714 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Enrollment rates to the trial were lower than projected and anticipated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
This trial examines the usefulness of two educational programs for parents with late-stage cancer who have a 5 - 17 year old child. The programs are designed to enhance the quality of the parent-child relationship and add to the parent's confidence in managing the impact of their cancer on their child. Educational programs may reduce anxiety and depression and improve the well-being and quality of life of parents with advanced cancers and their children.
Recruitment occurs nationally via referral to the Fred Hutch/University of Washington Cancer Consortium team.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (ENHANCING CONNECTIONS-PALLIATIVE CARE [EC-PC] PROGRAM): Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.
GROUP II (CONTROL): Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (enhancing connections-palliative care program) | Experimental | Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child. |
|
| Group II (educational material) | Active Comparator | Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive EC-PC program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy assessed by parents' mood (CES-D) | Depressed mood will be measured by the 20-item Center for Epidemiological Studies- Depression Scale (CES-D) (Benazon & Coyne, 2000; Lewis, Fletcher, Cochrane, & Fann, 2008; Radloff, 1977). The CES-D Scale measures the recent occurrence of symptoms of depression. For each symptom, the respondent indicates the frequency with which that symptom has occurred during the past week, from "rarely or none of the time (less than 1 day)" to "most or all of the time (5-7 days)." This measure has been well- accepted in both ill and non-ill samples. Internal consistency in three samples from the general population has been reported by Radloff (Radloff, 1977) and ranged between .84 to .85. Validity has been well- established, including its link to the broader concept of "distress" in cancer-related research (Benazon & Coyne, 2000; Coyne et al., 1987; Given et al., 2004) The internal consistency reliability is 0.85 or higher (Benazon & Coyne, 2000; Coyne et al., 1987; Given et al., 2004). | At 3 months post-baseline |
| Treatment efficacy assessed by parents' anxiety [Spielberger State-Trait Anxiety (STAI, state scale)] | State anxiety will be measured by the state component of the State-Trait Anxiety Inventory. This 20-item self-report questionnaire evaluates current feelings of apprehension, tension, nervousness, and worry. The respondent circles a response that best depicts their current feelings best. Response options range from [1 - Not at all] to [5 - Very much so]. Sample items include "I feel calm", I am tense." Higher scores denote greater anxiety. Internal consistency reliability is 0.90 or above in community and population samples [Edwards and Clarke, 2004] | At 3 months post-baseline |
| Parent's confidence in being able to talk with her child about the child's cancer-related concerns (CASE Help Child Subscale) | Parenting Self-efficacy: Measured by the Help Child subscale of the parent-reported cancer Self-efficacy Scale (CASE). The Help Child subscale (9 items) measures the parent's confidence in being able to talk with her child about the child's cancer-related concerns; e.g., "I can assist my child to talk out his/her worries about my cancer." Structured response options range from "Not at all confident" (1) to "Very confident." The internal consistency reliability The internal consistency reliabilities in the EC seminal trial with parents with early stage cancer was 0.97. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of parents' symptom burden on treatment outcomes: Condensed Memorial Symptom Assessment scale (CMSAS) - Physiological symptoms subscale | Using Linear Mixed Models, will examine the moderator effects of the diagnosed parent's symptom burden on intervention outcomes. Will be assessed using the physiological symptoms subscale (range of scores 0-4). | At 3-months post-baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frances M Lewis, RN, MN, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States | ||
| Fred Hutch/University of Washington Cancer Consortium |
Secondary analysis of data will be permitted after a specific plan is submitted to the Principal Investigator and Co-Investigators approve.
Plan should make explicit the analysis sample, rationale for study, aims of secondary analysis, proposed data analysis to be used, timeline for completion of analysis, and agreement to cite the parent study with appropriate acknowledgment.
Data will become available after filing FINAL Report to NINR, NIH and after the efficacy results and analysis of study aims are published.
Scientists prepared with a PhD or equivalent degree will be granted access for secondary analysis, after their specific proposed plan is submitted and reviewed by PI and Co-Invesigators.
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2026 | |
| Reset | Jun 8, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2023 | Jun 9, 2025 |
Not provided
2-group randomized control trial: experimental and alternative treatment control group
Not provided
Not provided
Only biostatistician will be unmasked.
| Informational Intervention | Other | Receive education booklet |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| At 3 months post-baseline |
| Parents' skills in helping their child cope and manage the toll of the parents' cancer (Connecting and Coping Subscale) | Parenting skills will be measured by the parent reported Parenting Skills Checklist: Connecting and Coping subscale developed by the study team and tested for reliability and validity in a 6-state randomized control trial (Lewis et al., 2015). The measure describes the observable interactional behaviors parents can use to assist their child disclose, discuss, and cope with the parent's cancer. The developmental-contextual model of parenting was the conceptual basis for the measure. An example item on the Connecting and Coping subscale includes, "I work with my child to help my child manage the child's stress related to my cancer." | At 3 months post-baseline |
| Child-Behavioral Emotional Functioning: Anxious/Depressed, Internalizing, Externalizing scores on CBCL | The child's behavioral-emotional adjustment will be measured by the Anxious/Depressed, Internalizing and Externalizing scores of the CBCL which is part of the Child Behavior Checklist. This measure will be obtained from both the ill parent and the non-ill parent/parent surrogate. Response options range from 0 to 2 from "Not True (as far as you know)" to "Somewhat or Sometimes True" to "Very True or Often True." This score is part of the Internalizing score of the CBCL that measures the child's fearful, inhibited, and over-controlled behavior. The internal consistency reliabilities for the EC clinical trial were 0.90 for the Internalizing score and 0.94 for the Externalizing score. For the current study, we will use the CBCL form for 6-18 year-olds and its computer software. | At 3 months post-baseline |
| Seattle |
| Washington |
| 98115 |
| United States |
| ICF_000.pdf |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2026 | Jun 8, 2026 | |||
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| 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 |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
Not provided
Not provided