Clinical trial NCT03871686: Promotion of Well-being of Young Adult Brain Cancer Survivors
Official title: Improving Well-being Among Young Adult Survivors of Childhood Brain Tumor: A Randomized Controlled Trial of a Brief Internet-based Behavioral Activation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor, Pediatric
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will take a 4-session Internet-based behavioral activation intervention and the control group will receive no treatment and may continue services as usual as provided by the Children's Brain Tumor Foundation.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effectiveness of an Internet-based, behavioral activation intervention to promote well-being in a young adult survivors of childhood brain tumor.

Detailed description: Participants will be recruited through the Children's Brain Tumor Foundation who will share the study announcement with their young adult members and social media. Eligible participants will complete a baseline battery survey via Qualtrics. The investigators will recruit 120 participants. The survey will take approximately 30 minutes to complete. Participants will be randomly assigned to an experimental group or control group. The experimental group will take an Internet-based behavioral activation intervention. The intervention has four modules and will be administered via Qualtrics. A link to each module will be sent to the participants via e-mail. Participants will have one week to complete each module. Once a participant completes a module, the next module link will be sent after 3 days. A reminder will be sent at 7 days and 10 days until the module is complete. Each module will take approximately 30 minutes to complete. The experimental group may continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will continue to receive services as usual from the Children's Brain Tumor Foundation. The control group will have an opportunity to take the intervention once data collection is complete. Both groups will be asked to complete a battery of surveys at the end of the intervention and intermittently over a 3-month period.

Eligibility criteria: Inclusion Criteria:

* History of childhood brain tumor
* Ages of 18 and 30 years.
* Have regular access to the Internet
* Provide an e-mail address

Exclusion Criteria:

* Those that do not meet the inclusion criteria.

Primary outcomes:
measure: Change from baseline PERMA-Profiler score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
Secondary outcomes:
measure: Change from baseline World Health Organization-Disability Assessment Schedule 2.0 score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change from baseline Life Satisfaction Scale (LiSat-9) score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change in baseline Perceived Stress Scale score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change in baseline Acceptance and Action Questionnaire (AAQ-II) score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change in baseline Behavioral Activation for Depression Scale (BADS-9) score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change in baseline Cognitive-Behavioral Social Self-Efficacy Scale score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change in baseline Vocational Outcomes Expectancy Scale score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change in baseline Perceived Barrier Scale score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
measure: Change in baseline General Self-Efficacy Scale score at 2 weeks and 3 months
timeFrame: At baseline; 2 weeks and 3 months after completing the intervention.
Other outcomes:
Locations:
city: New York
country: United States
facility: Children's Brain Tumor Foundation
state: New York
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy Tansey, PhD
role: PRINCIPAL_INVESTIGATOR
References: