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

Trial Summary

What is the purpose of this trial?

In this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with ALL receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. This is a novel approach to controlling an important and common treatment-related symptom.

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 data supports the effectiveness of the treatment Bright IDEAS for controlling nausea in children with leukemia?

The Bright IDEAS program, which focuses on problem-solving skills training, has been shown to effectively reduce distress in caregivers of children with cancer, suggesting it may help manage stress-related symptoms like nausea in children with leukemia. ^{1 2 3 4 5}

How does the Nausea Control Training treatment differ from other treatments for childhood leukemia?

The Nausea Control Training treatment is unique because it uses behavioral interventions, such as hypnosis and supportive counseling, to reduce nausea and vomiting in children undergoing chemotherapy. Unlike standard drug treatments, this approach focuses on mind/body techniques to manage symptoms, which can lead to lasting improvements even after the intervention ends. ^{6 7 8 9 10}

Research Team

Lee Dupuis, PhD

Principal Investigator

SickKids Research Institute

Eligibility Criteria

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

I or my guardian can communicate in English, French, or Spanish.

Without physical or cognitive impairments that preclude use of the PeNAT

I am 4 years old or older.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Bright IDEAS-Young Adults: A Problem-Solving Skills Training Intervention. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Improving Adherence to Evidence-Based Guidelines for Chemotherapy-Induced Nausea and Vomiting. [2018]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Responsivity to Problem-Solving Skills Training in Mothers of Children With Cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral intervention for reducing chemotherapy-related nausea and vomiting in adolescents with cancer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Chemotherapy-Induced Vomiting Control in Pediatric Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Pooled Analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Symptom monitoring and dependent care during cancer treatment in children: pilot study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of behavioral intervention for reduction of nausea and vomiting in children and adolescents receiving chemotherapy. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Patterns of nausea and vomiting in children: nursing assessment and intervention. [2005]