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The primary aims of the proposed trial are centered around examining the feasibility of conducting a prospective, chiropractic intervention study on a population of cancer survivors living in and around Atlanta, Georgia. This includes evaluating various implementation outcomes including recruitment, adherence, tolerability, retention, acceptability, and data fidelity. The results of this trial will inform the design of a future randomized controlled trial (RCT) that has an increased focus on the efficacy/effectiveness of chiropractic care on chronic cancer-related fatigue (CCRF) and other cancer-related sequelae in cancer survivors.
Cancer remission is often marked by the cessation of curative-intent treatments (e.g., surgery, chemotherapy, radiotherapy, immunotherapy), however, troublesome signs and symptoms (e.g., fatigue, depression, cognitive impairment, dysautonomia) related to the cancer and its treatments commonly persist for prolonged periods (i.e., months to years). Of these, chronic cancer-related fatigue (CCRF) is one of the most frequently reported and debilitating symptoms. CCRF may be characterized as tiredness or exhaustion persisting for 3 or more months following the completion of the primary curative-intent cancer therapies which is independent on one's quantity or quality of rest and causes impairments in daily functioning and quality of life. Notably, although the mechanisms underlying CCRF are still unclear, there is some evidence that it may be related to autonomic dysregulation.
Irrespective of the cause(s), lack of identification of and treatment for CCRF and other chronic cancer-related sequelae is commonplace. Further, empirical data supporting the efficacy of interventions to remediate these issues are relatively sparse and urgently needed as the global population of cancer survivors continues to increase. Of note, although there is no universally accepted definition of 'cancer survivor', the investigators define it here as someone who has completed their primary curative-intent therapies and is cancer-free (i.e., has no evidence of active disease). This definition is in line with that of the European Organisation of Research & Treatment of Cancer (EORTC) Survivorship Task Force and the EORTC Quality of Life Group.
Interestingly, a recent study suggested that a single chiropractic adjustment may mitigate lower extremity muscular fatigue during isometric exercise in young, healthy males. However, to the investigators' knowledge, the impact of chiropractic care on CCRF and other health-related challenges that burden cancer survivors has yet to be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiropractic intervention | Experimental | Upper cervical chiropractic care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic care | Procedure | 6 weeks of chiropractic care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment | Average number of participants recruited/enrolled per month | 6-month data collection period |
| Participant scheduling | Average time lag between first lab assessment & first chiropractic visit | 6-month data collection period |
| Participant compliance | Proportion of participants violating 1 or more pre-assessment lifestyle restrictions & unable/unwilling to be rescheduled | 6-month data collection period |
| Participant adherence | Proportion of participants not attending at least 80% of their chiropractic sessions | 6-month data collection period |
| Participant tolerability | Proportion of participants unable/unwilling to complete a given assessment | 6-month data collection period |
| Participant retention | Proportion of participants completing the trial | 6-month data collection period |
| Assessment acceptability | Most common patient-related acceptability score for each assessment process/procedure | 6-month data collection period |
| Data fidelity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Austin Garlinghouse | Contact | 770-426-2639 | research.studies@life.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yori 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 |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single-arm feasibility trial
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Proportion of acquisitions from a given assessment that are unsuitable for analysis
| 6-month data collection period |
| Implementation acceptability | Most common clinician-rated acceptability score for each trial process/procedure | 6-month data collection period |