Brain Tumor, PediatricNCT03871686
Promotion of Well-being of Young Adult Brain Cancer Survivors
A study testing Brief Internet-based Behavioral Activation Intervention in people with Brain Tumor, Pediatric, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Brain Tumor, Pediatric
- What is being tested?
- Brief Internet-based Behavioral Activation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 19 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of childhood brain tumor
- Ages of 18 and 30 years.
- Have regular access to the Internet
- Provide an e-mail address
Who cannot join
- Those that do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Brain Tumor Foundation
New York, New York, 10036
About this study
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
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.
Read the 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.
- Conditions
- Brain Tumor, Pediatric
- Being tested
- Brief Internet-based Behavioral Activation Intervention
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Internet-based Behavioral Activation InterventionBehavioural
Also called Taking Action and Making Commitment: A Well-being Prorgram
A brief Internet-based behavioral activation intervention consisting of 4 sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measures overall health, functioning, and disability. Total scores range from 0 to 24. Scores are summed with higher scores indicating greater functional disability severity.
Measured: 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
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.
Measured: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At baseline; 2 weeks and 3 months after completing the intervention.
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.
Measured: 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
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.
Measured: At baseline; 2 weeks and 3 months after completing the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start13 Feb 2019
- Primary completion19 May 2019
- Study completion19 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PediatricStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Tansey, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871686
- Sponsor's protocol ID
- 2019-0006
- Other IDs
- A177800, EDUC/REHAB PSYC&SP ED
- Status last verified
- Feb 2020
- First submitted
- 19 Jan 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03871686
- Acronym / sponsor ID
- 2019-0006
- Conditions
- Brain Tumor, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 19 May 2019 (actual)
- Study completion
- 19 May 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Brief Internet-based Behavioral Activation InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of childhood brain tumor
- Ages of 18 and 30 years.
- Have regular access to the Internet
- Provide an e-mail address
Key exclusion criteria (1 listed)
- Those that do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Internet-based Behavioral Activation InterventionAlso: Taking Action and Making Commitment: A Well-being ProrgramA brief Internet-based behavioral activation intervention consisting of 4 sessions. | Behavioural | Experimental Group |
Primary outcome
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.
9 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Tansey, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Internet-based Behavioral Activation Intervention in people with Brain Tumor, Pediatric, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.