Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer

NCT02758639 | Completed

• 1 other identifier: 201502573
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Over 73% of patients with children desire information and services to support their children yet only 9% of these families report receiving this support. The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a randomized controlled clinical trial (RCT) evaluating the Wonders \& Worries group and individual intervention for school age children (5 -14 years old) who have a parent with cancer. Families will be enrolled at the time of initial parent consultation, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.

Conditions

Cancer; Psychological Adjustment

Keywords

parental cancer; children psychosocial adjustment; psychosocial intervention

Outcome Measures

Primary Outcomes (9)

• Change in Child's Anxiety level (RCMAS) from baseline to 6 weeks and 8 week follow up

  Revised Children's Manifest Anxiety Scale - child self report

  Baseline, 6 week, 8 week follow up

• Change in Child's Emotional/Behavioral Status (CBCL) from baseline to 6 weeks and 8 week follow up

  Child Behavior Checklist - parent report

  Baseline, 6 week, 8 week follow up

• Change in Family Communication Scale FACES IV from baseline to 6 weeks and 8 week follow up

  parent \& child report

  Baseline, 6 week, 8 week follow up

• Change in The Family Quality of Life Scale (FQOL) from baseline to 6 weeks and 8 week follow up

  parent \& child report

  Baseline, 6 week, 8 week follow up

• Change in Cancer Self-Efficacy Scale (CASE) from baseline to 6 weeks and 8 week follow up

  parent report of parenting self efficacy

  Baseline, 6 week, 8 week follow up

• Change in Spielberger State-Trait Anxiety Inventory (STAI) from baseline to 6 weeks and 8 week follow up

  parent self report of anxiety

  Baseline, 6 week, 8 week follow up

• Change in Depression scale (CES-D) from baseline to 6 weeks and 8 week follow up

  parent self report of depression

  Baseline, 6 week, 8 week follow up

• Change in Parenting Concerns Questionnaire (PCQ) for adults with cancer from baseline to 6 weeks and 8 week follow up

  parent self report

  Baseline, 6 week, 8 week follow up

• Change in child's worries about their parent's illness from baseline to 6 weeks and 8 week follow up

  child self report of worries related to parent's illness AMMI-EC3- About My Mommy's Illness

  Baseline, 6 week, 8 week follow up

Study Arms (2)

W & W Intervention

EXPERIMENTAL

Wonders \& Worries Psychosocial intervention is a 6 week group or individual sessions for children who have a parent with cancer focusing on psycho-educational information about cancer, treatment and its side effects, feelings expression, positive coping strategies, and family communication about the illness.

Behavioral: Wonders & Worries Psychosocial Intervention

Wait list control

OTHER

Wait list group will complete baseline, 6 week and 8 week follow up measures and then will be enrolled to receive W \& W intervention.

Behavioral: Wonders & Worries Psychosocial Intervention

Interventions

Wonders & Worries Psychosocial Intervention BEHAVIORAL

Session 1: Getting to Know Each Other The goal is to create a sense of safety within the group so that the children feel comfortable discussing difficult topics. Session 2: Cancer Education to provide developmentally appropriate education about the illness, treatment, and side effects. Session 3: Cancer Treatment Center Tour: This session consists of a treatment center tour and education about treatment plan involved in family's care in a safe environment. Session 4: Feelings: The focus of this session is expression and validation of all feelings the children may experience. Session 5: Stress and Coping: Goal is to emphasize the different ways individuals cope and differentiate positive vs. negative coping strategies. Session 6: Hopes for the Future/Closure: An emphasis is made on the idea that positive things may evolve from the most difficult circumstances.

W & W Intervention; Wait list control

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Families with children ages 5-14 at time of study. Children have a parent with early stage cancer, and are English-speaking.

You may not qualify if:

• Children are not living in the home with the ill parent at least 50% of the time. Non-English speaking families.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Wonders & Worries: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (2)

• Phillips F, Prezio EA. Wonders & Worries: evaluation of a child centered psychosocial intervention for families who have a parent/primary caregiver with cancer. Psychooncology. 2017 Jul;26(7):1006-1012. doi: 10.1002/pon.4120. Epub 2016 Mar 8.

  PMID: 26954773 BACKGROUND

• Phillips F, Prezio EA, Currin-McCulloch J, Jones BL. Wonders & Worries: A randomized clinical trial of a psychosocial intervention for children who have a parent with cancer. Psychooncology. 2022 Aug;31(8):1399-1411. doi: 10.1002/pon.5943. Epub 2022 Apr 29.

  PMID: 35470518 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Farya Phillips, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 2, 2016
• Study Start: September 1, 2015
• Primary Completion: August 19, 2018
• Study Completion: August 19, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)