Nausea Control Training for Childhood Leukemia

Recruiting at 3 trial locations

Overseen By Tadi Hondonga

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must be taking: 6-mercaptopurine

Must not be taking: Corticosteroids

Disqualifiers: Relapsed ALL, Physical impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 sessions

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether special problem-solving training can help control nausea in children with acute lymphoblastic leukemia (ALL) who are taking the chemotherapy drug 6-mercaptopurine. The study tests a program called Bright Ideas - CIN Training, which involves sessions with a trainer to develop strategies and action plans to manage nausea. Children newly diagnosed with ALL, who are in maintenance therapy and experience nausea from their medication, might be a good fit for the trial. Participants and their guardians need to speak English, French, or Spanish, and the child should not receive other specific types of chemotherapy or steroids during the study period. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve the quality of life for children with ALL.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not be planned to receive certain types of chemotherapy or corticosteroids during the study period.

What prior data suggests that this problem-solving skill training is safe for children with leukemia?

Research has shown that the Bright Ideas program is safe and easy to use. This program aids children and young adults with cancer by teaching problem-solving skills. Studies have found participants consider this approach both doable and helpful. It involves working with a trainer to develop strategies for managing nausea and other treatment-related challenges.

No reports of negative effects or safety issues have emerged with the Bright Ideas training. Since it focuses on skills rather than medication, it avoids the side effects that drugs might cause. This makes it a promising method for managing chemotherapy-induced nausea without additional risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bright Ideas - CIN Training because it's a fresh approach to managing nausea in children with leukemia by using problem-solving skills rather than medication. Unlike traditional treatments that often involve anti-nausea drugs, this training empowers patients and their families to develop personalized action plans to tackle nausea. This method encourages active participation and adapts to each child's unique needs, potentially leading to better long-term control of symptoms and improved quality of life.

What evidence suggests that the Bright Ideas - CIN Training is effective for controlling nausea in children with leukemia?

Research has shown that the Bright IDEAS program improves problem-solving skills and reduces stress in caregivers and young adults. Several studies have found it successful in lowering stress symptoms and enhancing coping skills. In this trial, the Bright IDEAS program is specifically adjusted to help children with acute lymphoblastic leukemia (ALL) manage chemotherapy-induced nausea, a common side effect. Although specific data on its effectiveness for controlling nausea is still being gathered, the program's success in reducing stress and symptoms suggests potential benefits. Participants in this trial will engage in sessions to create personalized plans to tackle nausea using problem-solving techniques. ^{2 6 7 8 9}

Who Is on the Research Team?

Lee Dupuis, PhD

Principal Investigator

SickKids Research Institute

Are You a Good Fit for This Trial?

This trial is for children aged 4 years or older with newly diagnosed or recurrent Acute Lymphoblastic Leukemia (ALL) who speak English, French, or Spanish. They must be in maintenance therapy and not planned to receive certain types of chemotherapy or steroids during the study. Participants also need to be able to use a nausea assessment tool without cognitive impairments.

Inclusion Criteria

Without physical or cognitive impairments that preclude use of the PeNAT

I am 4 years old or older.

I am in maintenance therapy for my first diagnosis of ALL without relapse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Bright IDEAS-CIN training, which includes a minimum of three 30-minute to 1-hour sessions with a parent and patient (if developmentally appropriate). The sessions focus on problem-solving strategies to manage chemotherapy-induced nausea.

3 sessions

3 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the completion of CINV diaries for at least 5 days of each 7-day data collection period.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bright Ideas - CIN Training

Trial Overview The study tests if teaching problem-solving skills can help control nausea in children with ALL taking oral 6-mercaptopurine. It's a preliminary step to see if it's possible to do a larger trial on this approach for managing treatment-related nausea.

How Is the Trial Designed?

Group I: Bright Ideas- CIN Training Experimental Treatment 1 Intervention

The PSST will be delivered by a "trainer" in a minimum of three 30-minute to 1-hour sessions with a parent and patient (if developmentally appropriate). During the first session, the study team member will build rapport by understanding relevant personal background and medical information; introduce PSST and the Bright IDEAS paradigm; review the patients experience with nausea as reported in Phase 1 and at other times during treatment; promote problem-solving strategies and skills; and develop an anti-nausea action plan. During the second session, the trainer will discuss how well the prior action plan worked and reinforce successful outcomes or, if unsuccessful, return to the problem-solving steps to generate a new action plan. The third session will review progress on CINV control, assist in problem-solving as needed, and discuss how to continue to use the Bright IDEAS framework to resolve future issues with CINV or symptom management more broadly.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Rutgers Cancer Institute of New Jersey

Collaborator

Trials

72

Recruited

22,200+

Inova Fairfax Hospital

Collaborator

Trials

12

Recruited

7,700+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

In a study of 735 pediatric patients receiving highly or moderately emetogenic chemotherapy, younger age and shorter duration of the acute phase were linked to better control of chemotherapy-induced vomiting (CIV) during treatment.

The combination of ondansetron with aprepitant or fosaprepitant significantly improved the likelihood of achieving complete CIV control in the acute phase, which also positively influenced control in the delayed phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Chemotherapy-Induced Vomiting Control in Pediatric Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Pooled Analysis. Dupuis, LL., Tomlinson, GA., Pong, A., et al.[2021]

In a study involving 11 children with cancer, all participants reported experiencing nausea during chemotherapy, with fatigue and pain also being common symptoms, highlighting the significant symptom burden faced by these patients.

Care strategies that were effective in alleviating symptoms included distraction techniques, massage, and dietary changes, with systematic monitoring through the Therapy-Related Symptom Checklist helping caregivers and providers prioritize interventions based on symptom severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom monitoring and dependent care during cancer treatment in children: pilot study. Williams, PD., Schmideskamp, J., Ridder, EL., et al.[2019]

In a preliminary study involving 8 adolescents with cancer, a behavioral intervention significantly reduced nausea, vomiting, and the overall bother caused by chemotherapy, indicating its potential efficacy in managing side effects.

The intervention also helped lessen the disruption to daily activities caused by chemotherapy, suggesting that behavioral strategies can improve the quality of life for young patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral intervention for reducing chemotherapy-related nausea and vomiting in adolescents with cancer. Lebaron, S., Zeltzer, L.[2019]

Childhood cancer treatments have improved cure rates but have also led to increased side effects, particularly nausea and vomiting, which are common in affected children.

The review highlights the importance of nursing interventions, including assessment and innovative strategies, to manage these side effects, while also calling for more research to better understand and address nausea and vomiting in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of nausea and vomiting in children: nursing assessment and intervention. Hockenberry-Eaton, M., Benner, A.[2005]

Chemotherapy-induced nausea and vomiting (CINV) is a common side effect of chemotherapy, and antiemetic medications are effective in preventing and treating it, but adherence to evidence-based prescribing guidelines is often inconsistent among providers.

This quality improvement project highlighted the importance of reintroducing CINV antiemetic guidelines and providing direct feedback to healthcare providers to enhance compliance and ensure better care for children experiencing CINV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Adherence to Evidence-Based Guidelines for Chemotherapy-Induced Nausea and Vomiting. Wood, M., Hall, L., Hockenberry, M., et al.[2018]

In a study involving 51 children aged 6-17 undergoing chemotherapy, both hypnosis and supportive counseling significantly reduced nausea and vomiting symptoms, with p-values less than 0.001.

The positive effects of these behavioral interventions persisted even after the interventions were stopped, indicating a lasting benefit in managing chemotherapy-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy. Zeltzer, L., LeBaron, S., Zeltzer, PM.[2017]

In a study of 154 mothers participating in the Bright IDEAS problem-solving skills training program, 33% showed significant improvement in problem-solving skills immediately after treatment, with this rate increasing to 39% at follow-up.

Lower baseline problem-solving skills were a strong predictor of greater improvement, suggesting that targeting individuals with poorer skills may enhance the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsivity to Problem-Solving Skills Training in Mothers of Children With Cancer. Dolgin, MJ., Devine, KA., Tzur-Bitan, D., et al.[2021]

The Bright IDEAS problem-solving skills training (BI) was successfully adapted for caregivers of children with sickle cell disease, achieving a high recruitment rate of 94% (72 participants) and a reasonable retention rate of 49%, with 35 caregivers completing the program.

Caregivers who completed the BI program reported significant improvements in their problem-solving skills immediately after and three months post-intervention, while initial levels of distress were low and remained stable over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright IDEAS problem-solving skills training for caregivers of children with sickle cell disease: A two-site pilot feasibility trial. Young, M., Voll, M., Noll, RB., et al.[2023]

The Bright IDEAS (BI) problem-solving skills training has been shown to effectively reduce distress in caregivers of children newly diagnosed with cancer, based on data from over 1400 caregivers in four multisite randomized clinical trials.

The training program successfully educated 209 psychosocial professionals across 134 sites, who have since provided BI to 545 individuals, although further efforts are needed to integrate BI into routine pediatric oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of an evidence-based behavioral intervention to alleviate distress in caregivers of children recently diagnosed with cancer: Bright IDEAS. Voll, M., Fairclough, DL., Morrato, EH., et al.[2023]

The Bright IDEAS-YA intervention, adapted for young adults with cancer, showed good feasibility with 67.8% enrollment and 80.0% retention rates, indicating it is acceptable for this population.

Participants reported improvements in problem-solving skills and reductions in symptoms of depression and anxiety after completing the intervention, suggesting it may effectively address their unique emotional and social needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Bright IDEAS-Young Adults: A Problem-Solving Skills Training Intervention. Viola, AS., Kwok, G., Levonyan-Radloff, K., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04929899

NCT04929899 | Bright Ideas - CIN Feasibility Study This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children with ALL who ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8665732/

Bright IDEAS problem-solving skills training for caregivers ... Bright IDEAS problem-solving skills training (BI) is an evidence-based behavioral intervention that has been utilized extensively with caregivers of children ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002398

Problem-Solving Skills Training to Reduce Distress among ... In multiple randomized trials, Bright IDEAS has demonstrated effectiveness in increasing problem-solving skills, decreasing distress, and reducing symptoms of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9264826/

Feasibility and Acceptability of Bright IDEAS-Young Adults Results indicated that the Bright IDEAS-YA problem-solving skills training intervention was feasible and acceptable to young adults diagnosed ...

5. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=546012

Bright IDEAS: Problem-Solving Skills Training This coping skills training teaches a five-step problem-solving approach applicable to situations commonly encountered during pediatric cancer treatment.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04929899

NCT04929899 | Bright Ideas - CIN Feasibility Study This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children with ALL who ...

7. trialx.com trialx.com/clinical-trials/listings/276219/bright-ideas-cin-feasibility-study/

Bright Ideas - CIN Feasibility Study | Clinical Research Trial ... This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children ...

8. mdpi.com mdpi.com/2072-6694/14/13/3124

Feasibility and Acceptability of Bright IDEAS-Young Adults Results indicated that the Bright IDEAS-YA problem-solving skills training intervention was feasible and acceptable to young adults diagnosed with cancer. The ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11542117/

A Developmental Evaluation of the Bright Ideas Program Bright Ideas is an innovative program developed by KidsAbility's Rocket Discovery Centre, aiming enhance uptake of EIP through incubating ideas.