Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children

Cancer Clinical Trial

— EC-PC  

Official title:

Enhancing Connections-Palliative Care: A Cancer Parenting Program for Patients With Advanced Cancer and Their Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477784
• Other study ID #: RG1122669
• Secondary ID: R01NR019987-01A1
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Ellen H Zahlis
• Phone: 206 550-8471
• Email: zahlis[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1590
• Est. completion date: July 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Parent-Child Relations
• Parenting
• Survivorship

Intervention

Other:
• Educational Intervention
Receive EC-PC program
• Informational Intervention
Receive education booklet
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	At 3 months post-baseline
Primary	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
Primary	Child-Behavioral Emotional Functioning: Anxious/Depressed score on CBCL	The child's behavioral-emotional adjustment will be measured by the Anxious/Depressed score 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
Primary	Quality of Parent-ChildRelationship: Conflict, Closeness, Dependence Subscales	The Child-Parent Relationship Scale (CPRS) is a 15-item parent-reported measure assessing parent-child closeness and relational conflict. The stability and consistency of parents' perceptions of their relationships with their children (N = 563) has been evaluated across 3 years. The stability and consistency of parents' perceptions of their relationships with their children were evaluated in a large study sample of children (N = 563) across 3 years. Validity testing with the CBCL between the 2 subscales and total scale score were 0.83 for every age of child in the study. Alpha internal consistency reliability was 0.83 for relational conflict and 0.72 for closeness.	At 3 months post-baseline
Secondary	Child's scores on the CBCL [Anxious/depressed score; Internalizing problems; Externalizing problems] for children whose parents die during the time of their participation in the study	Will be examined using Linear Mixed Models on data from all occasions obtained from the non-ill parent.	Up to 10 months
Secondary	Effects of parents' symptom burden on treatment outcomes: Condensed Memorial Symptom Assessment scale (CMSAS) - Physical 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 physical symptoms subscale (range of scores 0-4).	Up to 10 months
Secondary	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).	Up to 10 months
Secondary	Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Cohesion subscale	Using Linear Mixed Models, will examine the moderator effects of the family environment (cohesion) on intervention outcomes. Will be assessed using the Cohesion subscale (range of scores 0-9).	Up to 10 months
Secondary	Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Expressiveness subscale	Using Linear Mixed Models, will examine the moderator effects of the family environment (expressiveness) on intervention outcomes. Will be assessed using the Expressiveness subscale (range of scores 0-9).	Up to 10 months
Secondary	Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Conflict subscale	Using Linear Mixed Models, will examine the moderator effects of the family environment (conflict) on intervention outcomes. Will be assessed using the Conflict subscale (range of scores 0-9).	Up to 10 months