Promotion of Well-being of Young Adult Brain Cancer Survivors

Brain Tumor, Pediatric Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871686
• Other study ID #: 2019-0006
• Secondary ID: A177800EDUC/REHA
• Status: Completed
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: May 19, 2019

Study information

• Verified date: February 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: May 19, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Pediatric

Intervention

Behavioral:
• Brief Internet-based Behavioral Activation Intervention
A brief Internet-based behavioral activation intervention consisting of 4 sessions.

Locations

Country	Name	City	State
United States	Children's Brain Tumor Foundation	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline World Health Organization-Disability Assessment Schedule 2.0 score at 2 weeks and 3 months	Measures overall health, functioning, and disability. Total scores range from 0 to 24. Scores are summed with higher scores indicating greater functional disability severity.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change from baseline Life Satisfaction Scale (LiSat-9) score at 2 weeks and 3 months	To measure satisfaction with life, the Life Satisfaction Questionnaire (LiSat-9; Fugl-Meyer et al., 1991) will be included. The LiSat-9 has 9 items; including one general life satisfaction item. There 8 are domain-specific items for vocational situation, financial situation, leisure, contact friends, sexual life, activities of daily living, family life, and partnership relationship. Items are rated on an Likert scale ranging from 1 (very dissatisfying) to 6 (very satisfying). Scoring consists of calculating the mean score. Higher scores indicate greater satisfaction with life.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change in baseline Perceived Stress Scale score at 2 weeks and 3 months	To measure perceived stress, the Perceived Stress Scale (PSS; Cohen & Williamson, 1988) will be used. The PSS is a widely used 10-item scale in which respondents rate how stressful (unpredictable, uncontrollable, and overloaded) they perceive their lives to have been within the past month. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scoring consists of calculating the mean score. Higher scores indicate greater perceived stress.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change in baseline Acceptance and Action Questionnaire (AAQ-II) score at 2 weeks and 3 months	The Acceptance and Action Questionnaire (AAQ-II) (Bond et al., 2011) consists of seven items to be answered on a scale of 1 (never true) to 7 (always true). The AAQ-II measures participants' willingness to live in accordance with their values, in contact with negative private events, and acceptance of these events. A higher total score indicates a higher level of psychological flexibility, that is higher acceptance and less experiential avoidance. Total mean score will be calculated.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change in baseline Behavioral Activation for Depression Scale (BADS-9) score at 2 weeks and 3 months	The Behavioral Activation for Depression Scale- Short Form (BADS-9) is a 9-item scale with scores ranging from 0 to 54, with high scores representing higher activation. Total mean scores will be calculated.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change in baseline Cognitive-Behavioral Social Self-Efficacy Scale score at 2 weeks and 3 months	The Cognitive-Behavioral Social Self-Efficacy Scale is an 18-item measure of perceived social self-efficacy. Item scores range from 1 (not confident at all) to 5 (very confident. Total scores range from 18 to 90, with higher scores representing greater perceived social self-efficacy. Total mean scores will be calculated.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change in baseline Vocational Outcomes Expectancy Scale score at 2 weeks and 3 months	The Vocational Outcome Expectancy Scale (VOES) measures outcome expectancy related to employment. It is an 11-item scale with item scores ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 11 to 55, with higher scores representing a greater expectation of attaining positive employment outcomes (i.e., obtaining or retaining employment). Total mean scores will be calculated.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change in baseline Perceived Barrier Scale score at 2 weeks and 3 months	The Perceived Career Barriers measure was developed to identify barriers to career development and employment of young adult survivors of pediatric brain tumors (Strauser et al., 2018). The 12-item measure uses an 11-point Likert Scale (0-10) with 0 being (not a barrier) and 10 being a (major barrier). A midpoint label of (somewhat of a barrier) is utilized. Total scores range from 0 to 110, with higher scores indicating greater perceived career barriers.	At baseline; 2 weeks and 3 months after completing the intervention.
Secondary	Change in baseline General Self-Efficacy Scale score at 2 weeks and 3 months	The General Self-Efficacy Scale (GSES) is a measure of general self-efficacy. It is a 10-item measure with item scores ranging from 1 (not true at all) to 4 (exactly true). Total scores range between 10 and 40, with a higher score indicating more self-efficacy.	At baseline; 2 weeks and 3 months after completing the intervention.