Clinical trial NCT05477784: Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children
Official title: Enhancing Connections-Palliative Care: A Cancer Parenting Program for Patients With Advanced Cancer and Their Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parenting
Parent-Child Relations
Cancer
Survivorship
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-07-28
Enrollment: 174
Sex: ALL
Minimum age (years): 23
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-group randomized control trial: experimental and alternative treatment control group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment efficacy assessed by parents' mood (CES-D)
timeFrame: At 3 months post-baseline
measure: Treatment efficacy assessed by parents' anxiety [Spielberger State-Trait Anxiety (STAI, state scale)]
timeFrame: At 3 months post-baseline
measure: Parent's confidence in being able to talk with her child about the child's cancer-related concerns (CASE Help Child Subscale)
timeFrame: At 3 months post-baseline
measure: Parents' skills in helping their child cope and manage the toll of the parents' cancer (Connecting and Coping Subscale)
timeFrame: At 3 months post-baseline
measure: Child-Behavioral Emotional Functioning: Anxious/Depressed score on CBCL
timeFrame: At 3 months post-baseline
measure: Quality of Parent-ChildRelationship: Conflict, Closeness, Dependence Subscales
timeFrame: At 3 months post-baseline
Secondary outcomes:
measure: 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
timeFrame: Up to 10 months
measure: Effects of parents' symptom burden on treatment outcomes: Condensed Memorial Symptom Assessment scale (CMSAS) - Physical symptoms subscale
timeFrame: Up to 10 months
measure: Effects of parents' symptom burden on treatment outcomes: Condensed Memorial Symptom Assessment scale (CMSAS) - Physiological symptoms subscale
timeFrame: Up to 10 months
measure: Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Cohesion subscale
timeFrame: Up to 10 months
measure: Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Expressiveness subscale
timeFrame: Up to 10 months
measure: Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Conflict subscale
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: University of Washington
name: Frances M Lewis, RN, MN, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: