Acute Lymphoblastic Leukemia ALL
Conditions
Keywords
Chemotherapy induced peripheral neuropathy, tracjectory, predictor, children, acute lymphoblastic leukemia
Brief summary
The goal of this study is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Chemotherapy induced peripheral neuropathy was assessed at one week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4 (T5), two weeks after T5 (T6), two weeks after T5 (T7). Patients' demographic and clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy are obtained at baseline.
Interventions
None listed
Sponsors
The Hong Kong Polytechnic University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with acute lymphoblastic leukemia * aged from 8 to 17 years * will receive vincristine according the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020) * conscious with sufficient cognitive abilities to understand and express their physical state and psychological feelings accurately * written informed assent is obtained from the children and their parents for their participation in the study
Exclusion criteria
* participating other experimental trials, such as electrical stimulation, exercise therapy may improve CIPN symptoms. * with severe complications, including but not limited to significant heart, brain, or lung function failure. * had peripheral neuropathy symptoms caused by other diseases like genetic diseases, spinal cord injury. * had neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy). * had central nervous system cancer or secondary cancer. * had multiple treatment like radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale | One week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4(T5), two weeks after T5(T6), two weeks after T6(T7) | For measuring participants' peripheral neuropathy induced by chemotherapy. The total score ranges from 0 to 65 with higher scores indicating more severe chemotherpay induced peripheral neuropathy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Screening tool for the assessment of malnutrition in pediatrics, STAMP | Baseline | The STAMP is used to assess the nutritional status of participants. The nutritional risk is divided into low risk (0-1 points), moderate risk (2-3 points), and high risk (≥4 points) based on the total score (0-9 points). |
| National Comprehensive Cancer Network (NCCN) distress thermometer (DT) | Baseline | The NCCN-DT was used to assess psychological distress among participants. A cut off value ≥4 for single-item DT screening tool is recommended to indicate a distressed patient. |
| A specific item - 'subjective sleep quality' from the Pittsburgh Sleep Quality Index scale, PSQI | Baseline | A specific item - 'subjective sleep quality' from PSQI is used to assess the participants' sleep quality. Answer is coded into a 0-3 score for this item, with higher score reflect poor sleep quality. |
| The therapy-related symptom checklist for children (TRSC-C) | Baseline | TRSC-C is used to assess the participants' physcial symptoms. This checklist contains 30 items divided into 7 factors (1) nutrition-related, (2) psychosocial/ central nervous system (CNS), (3) oropharyngeal, (4) bone marrow toxicity/neuropathy, (5) skin/other toxicities, (6) neurotoxicities, and (7) respiratory/other symptoms. The total TRSC-C score is computed as the average of the symptom scores for all 30 symptoms. Higher scores indicating greater severity of symptoms |
| Multidimensional Scale of Perceived Social Support, MSPSS | Baseline | MSPSS is used to assess the participants' perceived social support. The total score ranges from 12 to 84, with higher mean score indicate greater level of Perceived Social Support. |
| Paediatric Cancer Coping Scale, PCCS | Baseline | PCCS is used to assess the participants' coping strategies. This scale is divided into three domains: cognitive coping (14 items), problem-oriented coping (9 items) and defensive coping (10 items) with total 33 items. Each item is performed on a 4-point Likert scale from 0 (never) to 3 (always), with higher scores indicating the most frequently used coping strategies. |
| Leisure Score Index (LSI) of the Godin-Leisure-Time Exercise Questionnaire (GLTEQ) | Baseline | Leisure Score Index is used to assess the participants' physical activity level. A score of 24 or over indicate active physical activity and higher scores indicating higher levels of physical activity. |
Countries
China
Contacts
Primary ContactKa Yan Ho, PhD
Backup ContactTing MAO
Outcome results
None listed