Acute Lymphoblastic Leukemia (ALL)NCT04929899
Bright Ideas - CIN Feasibility Study
A study testing Bright Ideas - CIN Training in people with Acute Lymphoblastic Leukemia (ALL), run by The Hospital for Sick Children at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- Bright Ideas - CIN Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Mar 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
- newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
- English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
- without physical or cognitive impairments that preclude use of the PeNAT
- planned to receive PO 6-mercaptopurine
- not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Inova Children's Hospital
Falls Church, Virginia, 22042
Robin Dulman, rdulman@psvcare.org
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Lauren Guidry, lguidry@chla.usc.edu
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Katie Devine, PhD, katie.devine@rutgers.edu
Canada1 site, 1 recruiting
- Recruiting
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Lee Dupuis, PhD, 416-813-7654 ext. 309355, lee.dupuis@sickkids.ca
About this study
Official title: Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy
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.
Read the detailed description
This study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. It will preserve and enhance the patient's and family's autonomy with respect to self-care. If found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy.
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 experience nausea while receiving 6-mercaptopurine. Bright IDEAS is an 8-session face-to-face intervention with a caregiver. In this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. Sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. The final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. Investigators adapted Bright IDEAS to meet the specific problem of CINV by adapting it to 3 sessions focused specifically on CINV, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat.
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Being tested
- Bright Ideas - CIN Training
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Ideas - CIN TrainingBehavioural
Bright IDEAS is a validated problem-solving skill training intervention.
| Study group | Role | What they receive |
|---|---|---|
| Bright Ideas- CIN Training | Other | 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. Receives: Behavioral: Bright Ideas - CIN Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
A future trial will be feasible if
- 50% of patients deemed to be eligible to participate in Phase 1 consent/assent to participate
- the recruitment into Phase 2 of 20 evaluable patients across all participating centers within 24 months of study activation of whom 80% return a completed CINV diary for at least 5 days of each 7-day data collection period. A completed CINV diary contains at least one PeNAT score and a record of the time of each vomiting episode or noting the presence/absence of vomiting daily. Evaluable patients are defined as those who have completed at least one cycle of PSST.
Measured: 24 months from study activation
Secondary outcomes (1)
CIN and CIV incidence
Proportion of children who report CIN and chemotherapy-induced vomiting (CIV) in Phase 1 and Phase 2
Measured: 24 months from study activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Mar 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Inova Fairfax Hospital, Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Lee Dupuis, The Hospital for Sick Children
- Investigators
- Lee Dupuis, PhD, Principal investigator, SickKids Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929899
- Sponsor's protocol ID
- 1000073003
- Status last verified
- Jan 2025
- First submitted
- 8 Jun 2021
- Last updated
- 31 Jan 2025
- 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy
- ClinicalTrials.gov ID
- NCT04929899
- Acronym / sponsor ID
- 1000073003
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, Inova Fairfax Hospital, Children's Hospital Los Angeles
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Jun 2021 (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.
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.
Detailed description
This study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. It will preserve and enhance the patient's and family's autonomy with respect to self-care. If found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy.
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 experience nausea while receiving 6-mercaptopurine. Bright IDEAS is an 8-session face-to-face intervention with a caregiver. In this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. Sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. The final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. Investigators adapted Bright IDEAS to meet the specific problem of CINV by adapting it to 3 sessions focused specifically on CINV, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bright Ideas- CIN Training | Other | Behavioral: Bright Ideas - CIN TrainingThe 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 may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
- newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
- English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
- without physical or cognitive impairments that preclude use of the PeNAT
- planned to receive PO 6-mercaptopurine
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bright Ideas - CIN TrainingBright IDEAS is a validated problem-solving skill training intervention. | Behavioural | Bright Ideas- CIN Training |
Primary outcome
Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months
Time frame: 24 months from study activation
A future trial will be feasible if * 50% of patients deemed to be eligible to participate in Phase 1 consent/assent to participate * the recruitment into Phase 2 of 20 evaluable patients across all participating centers within 24 months of study activation of whom 80% return a completed CINV diary for at least 5 days of each 7-day data collection period. A completed CINV diary contains at least one PeNAT score and a record of the time of each vomiting episode or noting the presence/absence of vomiting daily. Evaluable patients are defined as those who have completed at least one cycle of PSST.
1 secondary outcome
CIN and CIV incidence
Time frame: 24 months from study activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- 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.
Lee Dupuis, PhD principal investigator
SickKids Research Institute
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Ideas - CIN Training in people with Acute Lymphoblastic Leukemia (ALL), run by The Hospital for Sick Children at 4 sites in 2 countries.
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 6 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Dupuis, PhD (416-813-7762, lee.dupuis@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months (time frame: 24 months from study activation). 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 31 Jan 2025.