Chronic Pain, Peripheral Nervous System Diseases
Conditions
Keywords
Chemotherapy
Brief summary
This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination.
Detailed description
This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination. This is a collaboration and part of the data will be combined with other data in this collaboration
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* all patients who have participated in a prospective questionnaire study
Exclusion criteria
* Not able to visit in person.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy | 5-year follow-up | For case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used. Numbers indicate confirmed neuropathy. |
| Chemotherapy-induced Neuropathic Pain | 5-year follow-up | Neuropathic pain grading system. Neuropathic pain was graded as possible, probable, or definite in accordance with the NeuPSIG grading system (Pascal M et al, Wellcome Open Research 2018). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS). | 5-year follow-up | Number of patients with mild, moderate or severe symptoms of depression or anxiety. Patient Reported Outcomes Measurement Information System (PROMIS) used to assess if the patients has a mild, moderat or severe symptoms of depression/anxiety. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild , moderate or severe symptoms of depression or anxiety. A higher score indicates worse outcome. The minimum is no depression or anxiety and the maximum is severe depression or anxiey. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75 |
| Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS). | 5-year follow-up | Mean scores using HADS of all participants. The score for anxiety and depression indicate the sum of 7 questions, each graded from 0 to 3. This means that a person can score between 0 (minimum) and 21 (maximum) for either anxiety or depression. Higher score meaning more symptoms of a possible depression or anxiety. |
| Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS). | 5-year follow-up | Number of patients with mild, moderate or severe fatigue. PROMIS used to assess if the patients has a mild, moderat or severe symptoms of fatique. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe symptoms of fatigue. The minimum is no fatigue (T-score\<50) and maximum severe fatigue (T-score ≥75). Higher scores mean a worse outcome. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75 |
| Quality of Life Using EuroQol (EQ-5D). | 5-year follow-up | The participants were asked to provided a score from 1-100 regarding quality of life on the Quality of life using EuroQol (EQ-5D). Minimum score 0, maximum score 100. A higher score indicate better outcome |
| Personality Using the 10-item Personality Inventory (TIPI). | 5-year follow-up | The Personality using the 10-item Personality Inventory (TIPI). TIPI is divided in 5 parameters Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness. Minimum value is 2 and maximum value i 14. Higher scores indicate more Openness, Conscientiousness, Extraversion, Agreeableness and Emotional Stability |
| Personality Using the International Personality Item Pool (IPIP). | 5-year follow-up | Personality using the International Personality Item Pool (IPIP). A score were given from answering 10 questions regarding emotionel stability. Each question has 5 possible answers from 1 very inaccuate to 5 very accurate. Minimum combined value 10, maximum combined value 50. Higher score indicates worse outcome. |
| Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS). | 5-year follow-up | Participants answered 13 question, which were each graded on a scale from 0-4 and combined to a sum scale.. The results are a mean score for all participants. The minimum value is 0 and the maximum value is 72. Higher scores indicate more Pain catastrophizing. |
| Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM). | 5-year follow-up | The fibers in the cornea were scanned in one eye with the Heidelberg Retina Tomograph III laser-scanning confocal microscope (Heidelberg Engineering GmbH, Heidelberg, Germany). An automatic programme calculated the cornea nerve branches density (CNBD) and the cornea nerve fiber density (CNFD). |
| Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST). | 5-year follow-up | Modified German Research Network on Neuropathic Pain QST protocol assessed sensory abnormalities after chemotherapy assessed with quantitative sensory testing (QST). |
| Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS). | 5-year follow-up | Numbers given is patients with mild, moderate or severe pain interference of the patients with neuropathic pain. Patient Reported Outcomes Measurement Information System PROMIS used to assess if the patients has a mild, moderate or severe symptoms of pain interference. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe pain interference. The mimimum is no interference (T-score \<50) and maximum is Severe (T-score≥70)). Severe indicated more interference |
| Pain Descriptors by Douleur Neuropathique 4 (DN4). | 5-Year follow-up | number of participants with a possible painful neuropathy with the Douleur Neuropathique 4DN4. Yes/no questions regarding symptoms and signs of neuropathic pain. In total the participants answered 7 questions. Each question is a yes or no and are combined to a sum score of number of positive answers. Minimum score is 0 and maximum score is 7. Higher score indicates larger probability of neuropathic Pain. A score of 3 or above indicates a possible painful neuropathy. |
| Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI). | 5-Year follow-up | The results were given on a scale from 0-100 for each of the 5 dimensions on the Neuropathic Pain Symptom Inventory (NPSI). Higher scores indicate worse symptoms. The sum score is the sum divided by 5. Minimum score is 0 and maximum score is 100. |
| Neuropathy Using the Toronto Clinical Scoring System (TCSS). | 5-year follow-up | The Toronto Clinical Scoring System(TCSS), grades the severity of neuropathy and consists of 6 questions with the presence and description of symptoms and a 7-item clinical examination with reflexes in the lower extremities and a bedside sensory testing with pinprick, vibration, temperature, light touch and position of the 1st toe. The score ranges from 0-19. Higher score indicate worse outcome. |
| Neuropathy Using the Total Neuropathy Score. | 5-year follow-up | The TNScompact consists of 7 questions regarding sensory symptoms, motor symptoms, autonomic symptoms, pin sensation, vibrations sensitivity, strength and tendon reflexes graded from 0-4. The scores are combined and thus 0 being the lowest score possible and 28 being the highest score possible. A high score indicate severe neuropathy. |
| Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI). | 5-year follow-up | A cut-off ≥ 4/13 abnormal responses has been suggested as the cut-off to define polyneuropathy. |
| Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor | 5-year follow-up | Measurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability). |
| Blood Samples DNA | 5-year follow-up | Numbers indicate the number of participants, who had a blood sample collected. Potential gene associations in the development of painful neuropathy will be assessed together with other samples in the DOLORisk collaboration. The results here present the number of subjects who had a DNA blood sample taken. |
| Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory | 5-year follow-up | Measurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability). |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy Patients treated with docetaxel or oxaliplatin. | 63 |
| Total | 63 |
Baseline characteristics
| Characteristic | Chemotherapy | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 27 Participants | — |
| Age, Categorical Between 18 and 65 years | 36 Participants | — |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 9.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 63 participants | — |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
Chemotherapy-induced Neuropathic Pain
Neuropathic pain grading system. Neuropathic pain was graded as possible, probable, or definite in accordance with the NeuPSIG grading system (Pascal M et al, Wellcome Open Research 2018).
Time frame: 5-year follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemotherapy | Chemotherapy-induced Neuropathic Pain | 19 Participants |
Chemotherapy-induced Peripheral Neuropathy
For case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used. Numbers indicate confirmed neuropathy.
Time frame: 5-year follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy | Chemotherapy-induced Peripheral Neuropathy | 21 participants |
Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).
Mean scores using HADS of all participants. The score for anxiety and depression indicate the sum of 7 questions, each graded from 0 to 3. This means that a person can score between 0 (minimum) and 21 (maximum) for either anxiety or depression. Higher score meaning more symptoms of a possible depression or anxiety.
Time frame: 5-year follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy | Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS). | Anxiety | 4.38 score on a scale | Standard Deviation 3.76 |
| Chemotherapy | Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS). | Depression | 2.40 score on a scale | Standard Deviation 2.34 |
Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).
Number of patients with mild, moderate or severe symptoms of depression or anxiety. Patient Reported Outcomes Measurement Information System (PROMIS) used to assess if the patients has a mild, moderat or severe symptoms of depression/anxiety. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild , moderate or severe symptoms of depression or anxiety. A higher score indicates worse outcome. The minimum is no depression or anxiety and the maximum is severe depression or anxiey. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75
Time frame: 5-year follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemotherapy | Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS). | Anxiety | 12 participants |
| Chemotherapy | Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS). | Depression | 12 participants |
| Chemotherapy | Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS). | Anxiety or Depression | 16 participants |
Blood Samples DNA
Numbers indicate the number of participants, who had a blood sample collected. Potential gene associations in the development of painful neuropathy will be assessed together with other samples in the DOLORisk collaboration. The results here present the number of subjects who had a DNA blood sample taken.
Time frame: 5-year follow-up
Population: Numbers indicate the number of participants, who had a blood sample collected. Not analyzed separately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy | Blood Samples DNA | 58 participants |
Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).
Number of patients with mild, moderate or severe fatigue. PROMIS used to assess if the patients has a mild, moderat or severe symptoms of fatique. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe symptoms of fatigue. The minimum is no fatigue (T-score\<50) and maximum severe fatigue (T-score ≥75). Higher scores mean a worse outcome. Mild: T-score ≥55 and \<65 Moderate: ≥65 and \<75 Severe ≥75
Time frame: 5-year follow-up
Population: Numbers given is patients with mild, moderate or severe fatigue.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemotherapy | Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS). | 25 Participants |
Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).
The fibers in the cornea were scanned in one eye with the Heidelberg Retina Tomograph III laser-scanning confocal microscope (Heidelberg Engineering GmbH, Heidelberg, Germany). An automatic programme calculated the cornea nerve branches density (CNBD) and the cornea nerve fiber density (CNFD).
Time frame: 5-year follow-up
Population: Missing data in 10 patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy | Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM). | CNBD | 30.5 units/mm2 | Standard Deviation 13.5 |
| Chemotherapy | Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM). | CNFD | 22.8 units/mm2 | Standard Deviation 7.8 |
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor
Measurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten (RRP) makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability). Superexcitability and subexcitablity are measured in the recovery period. The recovery cycle is characterized by changes in axonal excitability following a supramaximal conditioning stimulus. The cycle includes a relative refractory period (at short inter-stimulus intervals), superexcitable period (when the threshold is reduced), and subexcitable period (when the nerve is less excitable).
Time frame: 5-year follow-up
Population: Motor recordings from participants, refractoriness at 2.5 ms, superexcitability and subexcitability
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor | Refractoriness at 2.5 ms | 18.8 percentage of 100% | Standard Error 1.9 |
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor | Superexcitability | 21.8 percentage of 100% | Standard Error 0.8 |
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor | Subexcitability | 16.2 percentage of 100% | Standard Error 0.7 |
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor
Measurements found with threshold tracking. The most common motor parameters assessed with threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 22 for refractoriness at 2.5 ms, superexcitability and subexcitability).
Time frame: 5-year follow-up
Population: Motor recordings from participants, relative refractory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor | 3.0 ms | Standard Error 1 |
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory
Measurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability). Superexcitability and subexcitablity are measured in the recovery period. The recovery cycle is characterized by changes in axonal excitability following a supramaximal conditioning stimulus. The cycle includes a relative refractory period (at short inter-stimulus intervals), superexcitable period (when the threshold is reduced), and subexcitable period (when the nerve is less excitable).
Time frame: 5-year follow-up
Population: Sensory recordings from participants, refractoriness at 2.5 ms, superexcitability and subexcitability
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory | Refractoriness at 2.5 ms | 11.0 percentage of 100% | Standard Error 1.9 |
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory | Superexcitability | 17.4 percentage of 100% | Standard Error 0.8 |
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory | Subexcitability | 10.9 percentage of 100% | Standard Error 0.8 |
Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory
Measurements found with threshold tracking. The most common sensory parameters assessed with sensory threshold tracking. Outcomes are extracted from the QTrack software. The relative refractory period (RRP) is the interval of time during which a second action potential can be initiated, refractoriness is change in threshold by a preceding simple impulse, and specifically at 2,5 ms. A shorten RRP makes the nerve more excitable and longer RRP less excitable (values see result 21 for refractoriness at 2.5 ms, superexcitability and subexcitability).
Time frame: 5-year follow-up
Population: Sensory recordings from participants, the relative refractory period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory | 3.1 ms | Standard Error 1 |
Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).
A cut-off ≥ 4/13 abnormal responses has been suggested as the cut-off to define polyneuropathy.
Time frame: 5-year follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemotherapy | Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI). | 21 Participants |
Neuropathy Using the Toronto Clinical Scoring System (TCSS).
The Toronto Clinical Scoring System(TCSS), grades the severity of neuropathy and consists of 6 questions with the presence and description of symptoms and a 7-item clinical examination with reflexes in the lower extremities and a bedside sensory testing with pinprick, vibration, temperature, light touch and position of the 1st toe. The score ranges from 0-19. Higher score indicate worse outcome.
Time frame: 5-year follow-up
Population: Results wer missing in 4 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Neuropathy Using the Toronto Clinical Scoring System (TCSS). | 4.8 score on a scale | Standard Deviation 3.2 |
Neuropathy Using the Total Neuropathy Score.
The TNScompact consists of 7 questions regarding sensory symptoms, motor symptoms, autonomic symptoms, pin sensation, vibrations sensitivity, strength and tendon reflexes graded from 0-4. The scores are combined and thus 0 being the lowest score possible and 28 being the highest score possible. A high score indicate severe neuropathy.
Time frame: 5-year follow-up
Population: The results were missing for 5 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Neuropathy Using the Total Neuropathy Score. | 3.9 score on a scale | Standard Deviation 3 |
Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS).
Participants answered 13 question, which were each graded on a scale from 0-4 and combined to a sum scale.. The results are a mean score for all participants. The minimum value is 0 and the maximum value is 72. Higher scores indicate more Pain catastrophizing.
Time frame: 5-year follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS). | 7.6 score on a scale | Standard Deviation 9.4 |
Pain Descriptors by Douleur Neuropathique 4 (DN4).
number of participants with a possible painful neuropathy with the Douleur Neuropathique 4DN4. Yes/no questions regarding symptoms and signs of neuropathic pain. In total the participants answered 7 questions. Each question is a yes or no and are combined to a sum score of number of positive answers. Minimum score is 0 and maximum score is 7. Higher score indicates larger probability of neuropathic Pain. A score of 3 or above indicates a possible painful neuropathy.
Time frame: 5-Year follow-up
Population: Of the 63 included in the study, 19 patients had symptoms of neuropathic pain. The result are the number of participants with a possible painful neuropathy with the DN4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemotherapy | Pain Descriptors by Douleur Neuropathique 4 (DN4). | 13 Participants |
Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).
The results were given on a scale from 0-100 for each of the 5 dimensions on the Neuropathic Pain Symptom Inventory (NPSI). Higher scores indicate worse symptoms. The sum score is the sum divided by 5. Minimum score is 0 and maximum score is 100.
Time frame: 5-Year follow-up
Population: Of the 63 included in the study, 19 patients had symptoms of neuropathic pain. The result are the score of participants with a neuropathic pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI). | 23.3 score on a scale | Standard Deviation 20.9 |
Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).
Numbers given is patients with mild, moderate or severe pain interference of the patients with neuropathic pain. Patient Reported Outcomes Measurement Information System PROMIS used to assess if the patients has a mild, moderate or severe symptoms of pain interference. The scores from the questionnaires were converted into T-scores, which were used in grading the patients with mild, moderate or severe pain interference. The mimimum is no interference (T-score \<50) and maximum is Severe (T-score≥70)). Severe indicated more interference
Time frame: 5-year follow-up
Population: Of the 63 included in the study, 19 patients had symptoms of neuropathic pain. Numbers given is patients with mild, moderate or severe pain interference of the patients with neuropathic pain.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemotherapy | Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS). | 17 Participants |
Personality Using the 10-item Personality Inventory (TIPI).
The Personality using the 10-item Personality Inventory (TIPI). TIPI is divided in 5 parameters Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness. Minimum value is 2 and maximum value i 14. Higher scores indicate more Openness, Conscientiousness, Extraversion, Agreeableness and Emotional Stability
Time frame: 5-year follow-up
Population: Answers are missing for 1 participant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chemotherapy | Personality Using the 10-item Personality Inventory (TIPI). | Openness | 5.3 units on a scale | Standard Deviation 1.1 |
| Chemotherapy | Personality Using the 10-item Personality Inventory (TIPI). | Extraversion | 4.5 units on a scale | Standard Deviation 1.5 |
| Chemotherapy | Personality Using the 10-item Personality Inventory (TIPI). | Agreeableness | 4.9 units on a scale | Standard Deviation 1.1 |
| Chemotherapy | Personality Using the 10-item Personality Inventory (TIPI). | Conscientiousness | 5.2 units on a scale | Standard Deviation 1.1 |
| Chemotherapy | Personality Using the 10-item Personality Inventory (TIPI). | Emotional Stability | 5.2 units on a scale | Standard Deviation 1.3 |
Personality Using the International Personality Item Pool (IPIP).
Personality using the International Personality Item Pool (IPIP). A score were given from answering 10 questions regarding emotionel stability. Each question has 5 possible answers from 1 very inaccuate to 5 very accurate. Minimum combined value 10, maximum combined value 50. Higher score indicates worse outcome.
Time frame: 5-year follow-up
Population: Results from 1 participant were missing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Personality Using the International Personality Item Pool (IPIP). | 34.3 score on a scale | Standard Deviation 7.6 |
Quality of Life Using EuroQol (EQ-5D).
The participants were asked to provided a score from 1-100 regarding quality of life on the Quality of life using EuroQol (EQ-5D). Minimum score 0, maximum score 100. A higher score indicate better outcome
Time frame: 5-year follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chemotherapy | Quality of Life Using EuroQol (EQ-5D). | 78.4 units on a scale | Standard Deviation 17.2 |
Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).
Modified German Research Network on Neuropathic Pain QST protocol assessed sensory abnormalities after chemotherapy assessed with quantitative sensory testing (QST).
Time frame: 5-year follow-up
Population: Patients with an abnormal value indicating loss of function
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chemotherapy | Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST). | Abnormal thermal detection | 11 participants |
| Chemotherapy | Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST). | Abnormal vibration detection | 18 participants |
| Chemotherapy | Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST). | Abnormal mechanical detection threshold | 11 participants |
| Chemotherapy | Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST). | Abnormal paradoxical heat sensation | 16 participants |
| Chemotherapy | Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST). | Abnormal mechanical pain threshold | 8 participants |