Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children (EC-PC)
Enhancing Connections-Palliative Care: A Cancer Parenting Program for Patients With Advanced Cancer and Their Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 groups. Co-inhabiting non-ill parent or parent surrogate is also randomized with the patient but only the patient receives either the experimental or control group information.
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 I had 2 arms: Arm 1: Ill parents Arm 2: Non-ill parents. The enrolled non-ill parent did not provide data to evaluate the efficacy of the trial.
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.
Group II had 2 arms: Arm 1: Ill parents Arm 2: Non-ill parents. The enrolled non-ill parent did not provide data to evaluate the efficacy of the trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington D.C., District of Columbia, United States, 20007
- Georgetown University
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Washington
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Seattle, Washington, United States, 98115
- Fred Hutch/University of Washington Cancer Consortium
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents with any type of late-stage, non-curable cancer (determined by TNM stage IV cancer for solid tumors or 2 or more cycles of treatment failure with disease relapse in non-solid tumors)
- All therapies are allowable
- 23 years (yr.) to 68 yr. Age restriction exists for the patient based on parent having a child ages 5-17
- Patient must have a child (5yr. -17 yr.) living in the home at least 50% of the time and residential with non-ill parent or parent surrogate
- Read and write English as one of their languages of choice
- Have access to a telephone
- Ability to understand and the willingness to sign a written informed consent document. Read and write English as one of their languages of choice
Exclusion Criteria:
- Patient is in hospice at time of enrollment
- Non-ill co-parent does not consent to join study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Behavioral: Group 1: Educational counseling Group I (enhancing connections-palliative care 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. |
Enrolled parents received 5 telephone-delivered educational counseling interventions at 2-week intervals, the EC-PC Program.
Other Names:
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Active Comparator: Group II (educational material)
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. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment Efficacy Assessed by Parents' Mood-Center for Epidemiological Studies-Depression (CES-D)
Time Frame: At 3 months post-baseline
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Depressed mood will be measured by the 20-item Center for Epidemiological Studies- Depression Scale (CES-D) (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, 1977, and ranged between .84 to .85. Validity is well- established, including its link to the broader concept of "distress" in cancer-related research (Benazon & Coyne, 2000). The internal consistency reliability is 0.85 or higher (Benazon & Coyne, 2000). Total score ranges from 0-60. Higher scores denote worse outcome. Clinical cut off for distress is 16 or higher. |
At 3 months post-baseline
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Treatment Efficacy Assessed by Parents' Anxiety [Spielberger State-Trait Anxiety (STAI, State Scale)]
Time Frame: At 3 months post-baseline
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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]. Scale range: 20-80. Clinical cut off for distress is 40 or higher. Missing data imputation caused scores to be non-whole integers. |
At 3 months post-baseline
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Parent's Confidence in Being Able to Talk With Her Child About the Child's Cancer-related Concerns (CASE Help Child Subscale)
Time Frame: At 3 months post-baseline
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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. Higher scores denote better outcome. Range of scores: 0-90. There is no known clinical cutoff score on this measure. |
At 3 months post-baseline
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Parents' Skills in Helping Their Child Cope and Manage the Toll of the Parents' Cancer (Connecting and Coping Subscale)
Time Frame: At 3 months post-baseline
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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." Range of subscale: 0-50. Higher scores reflect a better outcome. There is no clinical cut off score for parents' skills. |
At 3 months post-baseline
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Child-Behavioral Emotional Functioning: Anxious/Depressed Score on the Child Behavioral Checklist (CBCL)
Time Frame: At 3 months post-baseline
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The child's behavioral-emotional adjustment will be measured by 3 subscales: the Anxious/Depressed scores, Internalizing Problems score, and Externalizing Problems scores, all part of the Child Behavior Checklist. See specific subscale scores, entered separately below. Response options for all subscales range from 0 to 2 from "Not True (as far as you know)" to "Somewhat or Sometimes True" to "Very True or Often True." Higher scores denote worse outcomes. Range of scores for Internalizing and Externalizing Problems is 34-100 and 50-100 for the Anxious/Depressed score. Internal consistency reliabilities were established as 0.90 for the Internalizing score and 0.94 for the Externalizing score. For the current study, the CBCL form for 6-18 year-olds and its computer software were used. The theoretical range of scores on the Anxious/Depressed score is 50-100. The theoretical range of the Internalizing and Externalizing problems subscales are both 34-100. |
At 3 months post-baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Condensed Memorial Symptom Assessment Scale (CMSAS) - Psychological Symptoms Subscale
Time Frame: At 3-months post-baseline
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Self-report quantitative scale of patient's reported symptoms. BUT this was assessed as a potential covariate in the efficacy analysis and was used as such. It is not a primary nor a secondary outcome. Scores range from 0-4 with higher scores denoting greater psychological symptoms. There is no known clinical cut off score. |
At 3-months post-baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frances M Lewis, RN, MN, PhD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG1122669
- R01NR019987-01A1 (U.S. NIH Grant/Contract)
- STUDY00011221 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2022-08714 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
Data will become available after filing FINAL Report to NINR, NIH and after the efficacy results and analysis of study aims are published.
IPD Sharing Access Criteria
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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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