Promotion of Well-being of Young Adult Brain Cancer Survivors

February 3, 2020 updated by: University of Wisconsin, Madison

Improving Well-being Among Young Adult Survivors of Childhood Brain Tumor: A Randomized Controlled Trial of a Brief Internet-based Behavioral Activation Program

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10036
        • Children's Brain Tumor Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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
A brief Internet-based behavioral activation intervention consisting of 4 sessions.
Other Names:
  • Taking Action and Making Commitment: A Well-being Prorgram
No Intervention: Control Group
Participants will receive no intervention from the investigators. Participants may continue services as usual as provided by Children's Brain Tumor Foundation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline PERMA-Profiler score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline World Health Organization-Disability Assessment Schedule 2.0 score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change from baseline Life Satisfaction Scale (LiSat-9) score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change in baseline Perceived Stress Scale score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change in baseline Acceptance and Action Questionnaire (AAQ-II) score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change in baseline Behavioral Activation for Depression Scale (BADS-9) score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change in baseline Cognitive-Behavioral Social Self-Efficacy Scale score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change in baseline Vocational Outcomes Expectancy Scale score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change in baseline Perceived Barrier Scale score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Change in baseline General Self-Efficacy Scale score at 2 weeks and 3 months
Time Frame: At baseline; 2 weeks and 3 months after completing the intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy Tansey, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-0006
  • A177800 (Other Identifier: UW Madison)
  • EDUC/REHAB PSYC&SP ED (Other Identifier: UW, Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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