Cancer Patients, Supportive Care, Young Adult
Conditions
Keywords
Young Adults, Cancer, Supportive Care
Brief summary
The purpose of this project is to evaluate efficacy of Bright IDEAS, an evidence-based problem-solving skills training (PSST) program, as a supportive care intervention for young adult (YA) cancer patients compared with enhanced usual psychosocial care with 344 young adult patients newly diagnosed with cancer.
Detailed description
Bright IDEAS-YA is a personalized approach to increase problem-solving ability by fostering positive appraisal of problems as solvable challenges that can be overcome and enhancing rational problem-solving skills to systematically work through any problem. Bright IDEAS-YA intervention consists of six 45-minute one-on-one sessions with a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach. Up to 344 young adult patients newly diagnosed with cancer will be recruited to participate in this multi-site randomized controlled trial, where the Bright IDEAS-YA intervention will be compared with enhanced usual psychosocial care. Efficacy will be evaluated by examining changes in psychosocial outcomes from baseline to post-intervention (3 months) and follow-up (6, 12 and 24 months). The extent to which changes in aspects of problem-solving ability mediate the intervention effects will be examined.
Interventions
BEHAVIORALBright IDEAS-YA
Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.
Sponsors
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a two-arm parallel randomized controlled trial (RCT) of the intervention versus enhanced usual psychosocial care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Current age 18-39 * Within 4 months of first diagnosis of any cancer * Cancer being treated with chemotherapy and/or radiation therapy and/or hematopoietic stem cell transplant * No documented or self-reported cognitive delay or impairment that would prevent completion of survey measures * English-speaking
Exclusion criteria
* Medical crisis or not receiving curative therapy per physician/treatment team report * Treatment involves surgery only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a) | From Baseline to Time 3 (about 6 months from baseline) | Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms. |
| Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) | From Baseline to Time 3 (about 6 months from baseline) | Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms. |
| Change in Functional Assessment of Cancer Therapy - General (FACT-G v4) | From Baseline to Time 3 (about 6 months from baseline) | This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a) | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline). | Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10. |
| Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline). | Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10. |
| Functional Assessment of Cancer Therapy - General (FACT-G v4) | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline). | This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatie Devine, PhD, MPH
Rutgers Cancer Institute of New Jersey
Participant flow
Recruitment details
Dates of recruitment: 2/10/2021- 3/12/24 Recruitment modes: in-person (in clinic), and remote (via email and phone).
Participants by arm
| Arm | Count |
|---|---|
| Bright IDEAS-YA Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.
Bright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach. | 171 |
| Enhanced Usual Care Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines. | 173 |
| Total | 344 |
Baseline characteristics
| Characteristic | Bright IDEAS-YA | Total | Enhanced Usual Care |
|---|---|---|---|
| Age, Continuous | 30.00 years STANDARD_DEVIATION 6.62 | 30.3 years STANDARD_DEVIATION 6.3 | 30.58 years STANDARD_DEVIATION 5.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 64 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants | 280 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 43 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 38 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 26 Participants | 11 Participants |
| Race (NIH/OMB) White | 105 Participants | 222 Participants | 117 Participants |
| Region of Enrollment United States | 171 Participants | 344 Participants | 173 Participants |
| Sex/Gender, Customized Female | 111 Participants | 215 Participants | 104 Participants |
| Sex/Gender, Customized Male | 60 Participants | 128 Participants | 68 Participants |
| Sex/Gender, Customized Non-Binary | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 171 | 3 / 173 |
| other Total, other adverse events | 0 / 171 | 0 / 173 |
| serious Total, serious adverse events | 6 / 171 | 3 / 173 |
Outcome results
Primary
Change in Functional Assessment of Cancer Therapy - General (FACT-G v4)
This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total.
Time frame: From Baseline to Time 3 (about 6 months from baseline)
Population: Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bright IDEAS-YA | Change in Functional Assessment of Cancer Therapy - General (FACT-G v4) | 6.06 score on a scale |
| Enhanced Usual Care | Change in Functional Assessment of Cancer Therapy - General (FACT-G v4) | 2.66 score on a scale |
p-value: 0.02995% CI: [0.34, 6.45]Mixed Models Analysis
Primary
Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
Respondents report symptoms on a 5-point rating scale from 1 never to 5 always in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms.
Time frame: From Baseline to Time 3 (about 6 months from baseline)
Population: Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bright IDEAS-YA | Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) | -2.21 T-score points |
| Enhanced Usual Care | Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) | 0.22 T-score points |
p-value: 0.00395% CI: [-4.05, -0.81]Mixed Models Analysis
Primary
Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)
Respondents report symptoms on a 5-point rating scale from 1 never to 5 always in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms.
Time frame: From Baseline to Time 3 (about 6 months from baseline)
Population: Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bright IDEAS-YA | Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a) | -2.92 T-score points |
| Enhanced Usual Care | Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a) | 0.31 T-score points |
p-value: <0.00195% CI: [-4.93, -1.53]Mixed Models Analysis
Secondary
Functional Assessment of Cancer Therapy - General (FACT-G v4)
This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total.
Time frame: Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Secondary
Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
Respondents report symptoms on a 5-point rating scale from 1 never to 5 always in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.
Time frame: Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Secondary
Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)
Respondents report symptoms on a 5-point rating scale from 1 never to 5 always in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.
Time frame: Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Other Pre-specified
Comprehensive Score for Financial Toxicity (COST)
Those who indicate financial responsibility will respond to the full 11-item scale of financial toxicity associated with cancer treatment. Respondents rate each item on a 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days. The measure yields a total summary score, with higher scores indicating greater financial strain.
Time frame: Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Other Pre-specified
PROMIS Social Isolation - Short Form 4a
This four-item measure assesses perceptions of social isolation on a 5-point scale from 1 (never) to 5 (always) in the past 7days. Higher scores indicating higher levels of perceived isolation.
Time frame: Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Other Pre-specified
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Ten-item scale assesses utility of intervention-specific components (e.g., the user manual, worksheets), attitude towards the intervention, trainer competence, and perceived benefit attributable to the intervention. Participants will answer on a 5 point scale, from 1 (strongly disagree) to 5 (strongly agree) with higher scores indicating higher satisfaction. This measure will be administered at post-intervention to intervention arm only.
Time frame: Time 2 (about 3 months from baseline).
Population: Intervention Arm only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Utility: User manual | 4.02 score on a scale | Standard Deviation 0.79 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Utility: Worksheets | 4.00 score on a scale | Standard Deviation 0.82 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Trainer: Warm and supportive | 4.74 score on a scale | Standard Deviation 0.63 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Trainer: Competent | 4.70 score on a scale | Standard Deviation 0.63 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Attitudes: Sessions' length | 4.37 score on a scale | Standard Deviation 0.75 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Attitudes: Number of sessions | 4.12 score on a scale | Standard Deviation 0.9 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | I liked the BrightIDEAS program | 4.37 score on a scale | Standard Deviation 0.67 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Perceived benefit: Effectiveness | 4.26 score on a scale | Standard Deviation 0.73 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Perceived benefit: Helpful | 4.08 score on a scale | Standard Deviation 0.85 |
| Bright IDEAS-YA | Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure | Would recommend to other YA | 4.16 score on a scale | Standard Deviation 0.96 |
Other Pre-specified
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S)
This 25-item self-report measure of five theoretically-important constructs of everyday problem-solving, including positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style. Respondents answer each item on 5-point Likert scale from 0 (not at all true of me) to 4 (extremely true of me). Summary scores ranging from 0-20 are computed for each subscale, as well as an overall score. A higher Total score indicates better problem-solving ability.
Time frame: Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Other Pre-specified
Support Services Received
Participants will check whether they have used or received services in the following categories: psychosocial support, informational and practical support, fertility or sexual health, physical/wellness services and integrative medicine services.
Time frame: Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Other Pre-specified
Unmet Needs and Concerns Measured by the Adolescent and Young Adult Oncology Screening Tool (Adapted Version - Young Adults)
Participants first rate their distress on a 0-10 scale. Higher score indicates higher distress. Next, they are asked to check off areas of concern from the past week, including practical (e.g., housing arrangements, work, bills, transportation), family (e.g., parents, siblings, partner), emotional (e.g., sadness, isolation, guilt), social (e.g., isolation from friends, missing important events), physical (e.g., body image, sexual concerns, sleeping difficulty), and informational (e.g., understanding information, feeling involved in decision-making) needs. A total score from 0 to 51 is calculated.
Time frame: Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).