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.
Study Type
INTERVENTIONAL
6 weeks of chiropractic care
Dr. Sid E. Williams Center for Chiropractic Research
Atlanta, Georgia, United States
Participant recruitment
Average number of participants recruited/enrolled per month
Time frame: 6-month data collection period
Participant scheduling
Average time lag between first lab assessment \& first chiropractic visit
Time frame: 6-month data collection period
Participant compliance
Proportion of participants violating 1 or more pre-assessment lifestyle restrictions \& unable/unwilling to be rescheduled
Time frame: 6-month data collection period
Participant adherence
Proportion of participants not attending at least 80% of their chiropractic sessions
Time frame: 6-month data collection period
Participant tolerability
Proportion of participants unable/unwilling to complete a given assessment
Time frame: 6-month data collection period
Participant retention
Proportion of participants completing the trial
Time frame: 6-month data collection period
Assessment acceptability
Most common patient-related acceptability score for each assessment process/procedure
Time frame: 6-month data collection period
Data fidelity
Proportion of acquisitions from a given assessment that are unsuitable for analysis
Time frame: 6-month data collection period
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Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Implementation acceptability
Most common clinician-rated acceptability score for each trial process/procedure
Time frame: 6-month data collection period