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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire | Participants will complete chemotherapy induced peripheral neuropathy, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy scales. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pediatric chemotherapy-induced peripheral neuropathy (P-CIN) scale | 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. | 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| The therapy-related symptom checklist for children (TRSC-C) | 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 |
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Exclusion Criteria:
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Children with acute lymphoblastic leukemia are recruited from inpatient wards in Shenzhen Children's Hospital, Henan Cancer Hospital and Shanghai Children's Medical Center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ka Yan Ho, PhD | Contact | 852-27666417 | kyeva.ho@polyu.edu.hk | |
| Ting MAO | Contact | 852-54844554 | tingting.mao@connect.polyu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Ka Yan Ho | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, | Recruiting | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Baseline |
| Screening tool for the assessment of malnutrition in pediatrics, STAMP | 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). | Baseline |
| National Comprehensive Cancer Network (NCCN) distress thermometer (DT) | 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. | Baseline |
| A specific item - 'subjective sleep quality' from the Pittsburgh Sleep Quality Index scale, PSQI | 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. | Baseline |
| Leisure Score Index (LSI) of the Godin-Leisure-Time Exercise Questionnaire (GLTEQ) | 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. | Baseline |
| Multidimensional Scale of Perceived Social Support, MSPSS | 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. | Baseline |
| Paediatric Cancer Coping Scale, PCCS | 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. | Baseline |
| Shanghai Children's Medical Center | Recruiting | Shanghai | China |
|
| Shenzhen Children's Hospital | Recruiting | Shenzhen | China |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |