Bright Ideas - CIN Feasibility Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04929899 |
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Recruitment Status :
Recruiting
First Posted : June 18, 2021
Last Update Posted : August 2, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Behavioral: Bright Ideas - CIN Training | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy |
| Actual Study Start Date : | March 1, 2022 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
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Bright Ideas- CIN Training
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. |
Behavioral: Bright Ideas - CIN Training
Bright IDEAS is a validated problem-solving skill training intervention. |
- 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.
- CIN and CIV incidence [ Time Frame: 24 months from study activation ]Proportion of children who report CIN and chemotherapy-induced vomiting (CIV) in Phase 1 and Phase 2
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04929899
| Contact: Lee Dupuis, PhD | 416-813-7654 ext X309355 | lee.dupuis@sickkids.ca | |
| Contact: Tatiana Son | 416-813-7654 ext 309465 | Tatiana.son@sickkids.ca |
| United States, New Jersey | |
| Rutgers Cancer Institute | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Katie Devine, PhD katie.devine@rutgers.edu | |
| Canada, Ontario | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Lee Dupuis, PhD 416-813-7654 ext 309355 lee.dupuis@sickkids.ca | |
| Principal Investigator: | Lee Dupuis, PhD | SickKids Research Institute |
| Responsible Party: | Lee Dupuis, Senior Associate Scientist, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT04929899 |
| Other Study ID Numbers: |
1000073003 |
| First Posted: | June 18, 2021 Key Record Dates |
| Last Update Posted: | August 2, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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