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Low recruitment rate
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| Name | Class |
|---|---|
| University of Haifa | OTHER |
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The main objectives of this single-arm pilot trial are to investigate the feasibility of our protocol in terms of 1) recruitment, 2) adherence, 3) tolerability, 4) acceptability and 5) retention. We aim to recruit 20 participants with advanced colon cancer (stage 3-4) who will have assessments of their autonomic nervous system function, carcinoembryonic antigen (CEA) levels, and patient-reported outcomes. Thereafter, patients will be directed to a nearby field clinic to receive twice-weekly cervical assessments & high-velocity, low-amplitude (HVLA) cervical adjustments for a period of 6 weeks. Re-assessments will be performed following 2 weeks and 6 weeks of chiropractic care.
After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 1, Week 2, and Week 6) that each include the following:
Each assessment will consist of the following recordings:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiropractic | Experimental | Cervical chiropractic care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVLA cervical chiropractic adjustments | Procedure | Chiropractic high velocity low amplitude adjustment |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Length of time needed to recruit target number of participants | Upon reaching target number of completed participant trials |
| Patient adherence rate | Proportion of participants able to adhere to the testing & treatment protocol/schedule | Upon reaching target number of completed participant trials |
| Patient tolerability rate | Proportion of participants able to perform all aspects of the testing regimen | Upon reaching target number of completed participant trials |
| Acceptability of treatment regimen to participants | 8-item Theoretical Framework of Acceptability questionnaire | Week 6 |
| Patient Retention | Proportion of enrolled participants who complete the full trial | Upon reaching target number of completed participant trials |
| Measure | Description | Time Frame |
|---|---|---|
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Day 1 |
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Sullivan, DC, PhD | Life University | Study Director |
| Yoram Gidron, PhD | University of Haifa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sid E. Williams Center for Chiropractic Research | Atlanta | Georgia | 30308 | United States |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Single-Arm pilot
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| Week 2 |
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Week 6 |
| Electrodermal activity (EDA) power spectral density (PSD) | 2 sensors on first and second digits of non-dominant hand | Day 1 |
| Electrodermal activity (EDA) power spectral density (PSD) | 2 sensors on first and second digits of non-dominant hand | Week 2 |
| Electrodermal activity (EDA) power spectral density (PSD) | 2 sensors on first and second digits of non-dominant hand | Week 6 |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Day 1 |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Week 2 |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Week 6 |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Day 1 |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Week 2 |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Week 6 |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Day 1 |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Week 2 |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Week 6 |
| ECG interbeat interval | 3 sensors on torso | Day 1 |
| ECG interbeat interval | 3 sensors on torso | Week 2 |
| ECG interbeat interval | 3 sensors on torso | Week 6 |
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Day 1 |
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Week 2 |
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Week 6 |
| ECG de-trended fluctuation analysis | 3 sensors on torso | Day 1 |
| ECG de-trended fluctuation analysis | 3 sensors on torso | Week 2 |
| ECG de-trended fluctuation analysis | 3 sensors on torso | Week 6 |
| Carcinoembryonic antigen (CEA) levels | Off-site blood draw and lab testing | Day 1 |
| Carcinoembryonic antigen (CEA) levels | Off-site blood draw and lab testing | Week 6 |
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Day 0 |
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Day 1 |
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Week 2 |
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Week 6 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |