Promotion of Well-being of Young Adult Brain Cancer Survivors

NCT03871686 | Completed

• 3 other identifiers: 2019-0006A177800EDUC/REHAB PSYC&SP ED
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor, Pediatric

Outcome Measures

Primary Outcomes (1)

• Change from baseline PERMA-Profiler score at 2 weeks and 3 months

  The PERMA-Profiler is a general measure of well-being (Butler \& Kern, 2016). The PERMA-Profiler measures Seligman's (2011) five pillars of well-being: positive emotion, engagement, relationships, meaning, and accomplishment. The measure consists of 23 items, including three items for each domain. The health, negative emotion, loneliness, and overall happiness items act as filler questions and provide more information. Items are rated on an 11-point Likert scale ranging from 0 (never) to 10 (always), or 0 (not at all) to 10 (completely). Scores are calculated as the average of the items comprising each factor. Butler and Kern (2016) suggested that the multidimensional structure be retained, rather than condensing responses; however, a single well-being score may provide a global indication of well-being. Therefore, for the current study, total scores for each subscale will be calculated as well as the total scores. Change from baseline total score will be assessed.

  At baseline; 2 weeks and 3 months after completing the intervention.

Secondary Outcomes (9)

• Change from baseline World Health Organization-Disability Assessment Schedule 2.0 score at 2 weeks and 3 months

  At baseline; 2 weeks and 3 months after completing the intervention.

• Change from baseline Life Satisfaction Scale (LiSat-9) score at 2 weeks and 3 months

  At baseline; 2 weeks and 3 months after completing the intervention.

• Change in baseline Perceived Stress Scale score at 2 weeks and 3 months

  At baseline; 2 weeks and 3 months after completing the intervention.

• Change in baseline Acceptance and Action Questionnaire (AAQ-II) score at 2 weeks and 3 months

  At baseline; 2 weeks and 3 months after completing the intervention.

• Change in baseline Behavioral Activation for Depression Scale (BADS-9) score at 2 weeks and 3 months

  At baseline; 2 weeks and 3 months after completing the intervention.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants will be asked to complete a brief online program over a 4 to 8-week period. Each week participants will be asked to complete one session of the program online. There are four sessions.

Behavioral: Brief Internet-based Behavioral Activation Intervention

Control Group

NO INTERVENTION

Participants will receive no intervention from the investigators. Participants may continue services as usual as provided by Children's Brain Tumor Foundation.

Interventions

Brief Internet-based Behavioral Activation Intervention BEHAVIORAL

A brief Internet-based behavioral activation intervention consisting of 4 sessions.

Also known as: Taking Action and Making Commitment: A Well-being Prorgram

Experimental Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Children's Brain Tumor Foundation

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Timothy Tansey, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigators and participants will know which arm of the study participants are randomly assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: March 12, 2019
• Study Start: February 13, 2019
• Primary Completion: May 19, 2019
• Study Completion: May 19, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)