Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04889755 |
| Other study ID # |
5870E |
| Secondary ID |
R03CA259898 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Boston University Charles River Campus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to address barriers to psychosocial care for siblings of children with cancer
by piloting a group-based telehealth program for adolescent siblings of youth with cancer.
The pilot trial will be preceded by a treatment development stage during which study staff
will interview English- and Spanish-speaking families and psychosocial providers to assess
preferences for program content, format, timing, and cultural feasibility and acceptability,
while considering ideas to minimize participation barriers. Information from interviews will
inform any revisions to the proposed pilot program. Then, the new SibACCESS program will be
tested with a small group of families located in Massachusetts, Delaware, or Rhode Island
using video-teleconferencing technology. Families will complete exit interviews to assess
program acceptability and perceived benefits.
Description:
Background:
Prolonged, complicated, and intensive pediatric cancer treatment regimens challenge and
disrupt the entire family. Siblings of youth with cancer are a psychosocially at-risk and
underserved group. Siblings frequently report strong negative emotions, disruptions to family
life, poorer academic functioning, more school absenteeism (school-aged siblings), and
riskier health behaviors and poorer health outcomes than comparisons (adult siblings).
Approximately one-quarter of siblings meet diagnostic criteria for cancer-related
posttraumatic stress disorders. Outcomes are worse for siblings from under-represented
minority groups and those with fewer socioeconomic resources. Additionally, siblings report
low social support and indicate a strong desire to connect with other siblings. The need for
sibling support is well established, as outlined in the recently developed evidence- and
consensus-based Standards for Psychosocial Care for Children with Cancer and Their Families.
Unfortunately, the Sibling Standard is among those least likely to be met within pediatric
oncology programs nationwide.
SibACCESS Program Description:
SibACCESS (Acceptance, Coping, Communication, Engagement, and Social Support) targets the
proposed mechanisms of sibling difficulties. The primary goal is to increase siblings'
exposure and opportunities to process cancer-related cues to decrease the onset or
intensification of posttraumatic stress (PTS). Treatment targets include emotional
acceptance, treatment involvement, family communication (via between-session assignments),
and social support (fostered by the group format).
SibACCESS is based on acceptance-based cognitive-behavioral frameworks, drawing primarily on
trauma-focused CBT (TF-CBT). TF-CBT is a structured, short-term treatment that incorporates
cognitive-behavioral approaches to promote recovery from trauma. It is a logical starting
point for the present study for multiple reasons: (a) TF-CBT was developed specifically for
children and adolescents; parent participation is recommended but not required; (b) it has
been tested in a group format and using telehealth; (c) it has demonstrated effectiveness
across cultural groups; and (d) it is appropriate for youth who meet diagnostic criteria for
PTSD and those with sub-clinical PTS. TF-CBT has not yet been evaluated in the context of
childhood cancer and may require some adaptations. Thus, SibACCESS also includes skills from
Dialectical and Behavioral Therapy (i.e., self-validation of emotions, mindfulness, radical
acceptance) to better address distress tolerance and acceptance of the aspects of cancer that
are beyond siblings' control.
SibACCESS sessions will be facilitated remotely using Zoom. The intervention includes one
pre-recorded parent webinar, one brief orientation meeting (sibling and parent), seven weekly
sibling group sessions, one individual sibling session, and one individual parent session.
The 30-minute parent webinar will provide a program overview, psychoeducation, and brief
skills training. Parents will be given "discussion starter" questions to facilitate
communication throughout the program. Sibling group sessions are 75 minutes and will include
an ice breaker, review of last week's homework (except first session), introduction of new
topics, interactive practice of new skills, and assignment of home practice (except final
session). Exposure to cancer-related emotions and cues will be emphasized throughout the
program, including talking about cancer, confronting cancer-related thoughts and emotions,
selecting several individualized cancer-related exposures, and crafting a sibling narrative.
