Promotion of Well-being of Young Adult Brain Cancer Survivors
Primary Purpose
Brain Tumor, Pediatric
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Internet-based Behavioral Activation Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Brain Tumor, Pediatric
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.
Sites / Locations
- Children's Brain Tumor Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
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.
Participants will receive no intervention from the investigators. Participants may continue services as usual as provided by Children's Brain Tumor Foundation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03871686
First Posted
January 19, 2019
Last Updated
February 3, 2020
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT03871686
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
May 19, 2019 (Actual)
Study Completion Date
May 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Pediatric
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Investigators and participants will know which arm of the study participants are randomly assigned to.
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will receive no intervention from the investigators. Participants may continue services as usual as provided by Children's Brain Tumor Foundation.
Intervention Type
Behavioral
Intervention Name(s)
Brief Internet-based Behavioral Activation Intervention
Other Intervention Name(s)
Taking Action and Making Commitment: A Well-being Prorgram
Intervention Description
A brief Internet-based behavioral activation intervention consisting of 4 sessions.
Primary Outcome Measure Information:
Title
Change from baseline PERMA-Profiler score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Secondary Outcome Measure Information:
Title
Change from baseline World Health Organization-Disability Assessment Schedule 2.0 score at 2 weeks and 3 months
Description
Measures overall health, functioning, and disability. Total scores range from 0 to 24. Scores are summed with higher scores indicating greater functional disability severity.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change from baseline Life Satisfaction Scale (LiSat-9) score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change in baseline Perceived Stress Scale score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change in baseline Acceptance and Action Questionnaire (AAQ-II) score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change in baseline Behavioral Activation for Depression Scale (BADS-9) score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change in baseline Cognitive-Behavioral Social Self-Efficacy Scale score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change in baseline Vocational Outcomes Expectancy Scale score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change in baseline Perceived Barrier Scale score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
Title
Change in baseline General Self-Efficacy Scale score at 2 weeks and 3 months
Description
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.
Time Frame
At baseline; 2 weeks and 3 months after completing the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Tansey, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Brain Tumor Foundation
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Promotion of Well-being of Young Adult Brain Cancer Survivors
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