Trial · NCT07913958
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity | at baseline and 12 weeks follow-up | Sensory symptom severity assessed using the sensory subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20). Scores range from 9 to 36, with higher scores indicating greater sensory symptom severity. |
| Secondary | Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity | at baseline, 4, 8, 12 and 24 weeks follow-up | Sensory, motor and autonomic symptoms of CIPN measured using the sensory, motor and autonomic subscale of the Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20). Each subscale score will be linearly transformed to a 0-100 scale with higher scores indicating greater symptom burden. |
| Secondary | Chemotherapy-induced peripheral neuropathy (CIPN) signs | at baseline, 12 and 24 weeks follow-up | The Total Neuropathy Score clinical version (TNSc) is used to evaluate motor symptoms, pin sensation, vibration sensibility, tendon reflexes and strength in the hands and feet (score range 0-20, higher scores indicating greater severity of neuropathy).In addition, quantitative sensory testing (QST) is performed to assess sensory nerve function, including vibration, thermal and mechanical detection and pain thresholds. Together, these measures provide a comprehensive assessment of clinical signs and sensory dysfunction associated with CIPN. |
| Secondary | Pain severity hands and feet | at baseline, 4, 8, 12 and 24 weeks follow-up | Pain severity in the hands and feet will be evaluated with a Visual Analogue Scale (VAS). Four VAS scales will be completed: pain intensity at the present moment, mean pain intensity (global average pain intensity over the past week), maximum pain intensity (pain intensity at its maximum over the past week) and minimum pain intensity (pain intensity at its minimum over the past week). |
| Secondary | General pain location and interference | at baseline, 12 and 24 weeks follow-up | Pain location and pain interference will be evaluated with the Brief Pain Inventory (BPI), including a body diagram to identify painful body areas and a pain interference section measuring how pain impacts various aspects of daily life, including mood, sleep, work and social activities (score range 0-70, higher scores mean a worse outcome). |
| Secondary | Physical functioning | at baseline, 12 and 24 weeks follow-up | Evaluated with the PROMIS Short Form v2.0 Physical Function 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome). |
| Secondary | Self-reported physical activity | at baseline, 12 and 24 weeks follow-up | Self-reported levels of physical activity are measured using the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTPAQ/GLTEQ). The score is calculated based on the weekly frequency of strenuous, moderate, and mild leisure-time physical activity sessions lasting more than 15 minutes. Higher scores indicate higher levels of self-reported physical activity. |
| Secondary | Objective physical activity | at baseline, 12 and 24 weeks follow-up | Minutes spent in different intensity zones (sedentary, light, moderate, vigorous) will be collected using a Fitbit device. |
| Secondary | Fatigue | at baseline, 12 and 24 weeks follow-up | Evaluated with the Multidimensional Fatigue Inventory (score range 20-100, higher scores mean a worse outcome). |
| Secondary | Sleep disturbance | at baseline, 12 and 24 weeks follow-up | Evaluated with the PROMIS Short Form v1.0 Sleep Disturbance 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome). |
| Secondary | Depression | at baseline, 12 and 24 weeks follow-up | Evaluated with the PROMIS Short Form v1.0 Depression 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome). |
| Secondary | Anxiety | at baseline, 12 and 24 weeks follow-up | Evaluated with the PROMIS Short Form v1.0 Anxiety 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome). |
| Secondary | Social participation | at baseline, 12 and 24 weeks follow-up | Evaluated with the PROMIS Short Form v2.0 Ability to participate in social roles and activities 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome). |
| Secondary | Support | at baseline, 12 and 24 weeks follow-up | Evaluated with the PROMIS Short Form v2.0 Emotional support 4a, PROMIS Short Form v2.0 Instrumental support 4a and PROMIS Short Form v2.0 Informational support 4a questionnaires (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome). |
| Secondary | Cognitive function | at baseline, 12 and 24 weeks follow-up | Evaluated with the Cognitive Failure Questionnaire (score range 0-100, higher scores mean a worse outcome). |
| Secondary | Health-related quality of life | at baseline, 12 and 24 weeks follow-up | Evaluated with the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire, including the index score (based on the Belgian value set) and the EQ VAS (range 0-100), with higher scores indicating better health outcomes. |
| Other | Compliance - adherence to exercise intervention | From enrollment to the end of the intervention period at 12 weeks] | Evaluated with a self-composed questionnaire. |
| Other | Beliefs about the efficacy of treatment | at 12 weeks follow-up | Evaluated with the Patient Global Impression of Change questionnaire (score range 1-7, higher scores mean a worse outcome). |
| Other | Safety of exercise intervention | From enrollment to the end of the intervention period at 12 weeks | Evaluated with a self-composed questionnaire. |
| Other | Patient experiences with exercise intervention | at 12 weeks follow-up | Evaluated with a self-composed questionnaire. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07913958/registered