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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02052 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19530 | Other Identifier | City of Hope Comprehensive Cancer Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies the effect of an interdisciplinary program with strong patient involvement on managing long-term chronic pain for cancer survivors. The purpose of this study is to determine whether enrolling patients into an interdisciplinary program can improve mobility with physical and occupational therapy and participation in online group psychotherapy that teaches coping skills to enhance quality of life.
PRIMARY OBJECTIVE:
I. To test the feasibility of an interdisciplinary functional restoration program in cancer survivors with chronic pain and restoring physical function.
EXPLORATORY OBJECTIVE:
I. To explore the preliminary effect of functional restoration program (FRP) in restoring physical function and reducing pain which ultimately decreases opioid consumption.
OUTLINE:
Patients participate in the cancer pain rehabilitation program for 6 weeks, including educational sessions over 2 hours once weekly, group psychological interventions, group physical therapy, and 1:1 physical and occupational therapy treatment per the patient's treatment plan. Patients may also undergo osteopathic manual treatments per physical and occupational therapy assessments.
After completion of study intervention, patients are followed up at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (cancer pain rehabilitation program) | Experimental | Patients participate in the cancer pain rehabilitation program for 6 weeks, including educational sessions over 2 hours once weekly, group psychological interventions, group physical therapy, and 1:1 physical and occupational therapy treatment per the patient's treatment plan. Patients may also undergo osteopathic manual treatments per physical and occupational therapy assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | Participate in group psychological intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Functional Restoration Program | Feasibility of the program will be determined by the proportion of referred eligible cancer survivors enrolled into the program (at least 50% who are eligible enroll) and the proportion of enrolled patients completed at least half of the intervention. | 24 months from the intervention date |
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| Measure | Description | Time Frame |
|---|---|---|
| Preliminary effect of the Functional Restoration Program in reducing pain (NSR) | Pain Numerical Rating Scale (NSR) score: patients are asked to circle the number between 0 and 10, zero usually represents 'no pain at all' whereas the upper limit 10 represents 'the worst pain ever possible'. | Pre-intervention , End of intervention (6 weeks), 3 months post-intervention |
Inclusion Criteria:
Exclusion Criteria:
Patients who are less than the age of 18 or have active problems with addiction will be excluded:
Those identified with illicit substance abuse or addiction will be referred to an addiction specialist or medication assisted treatment program through our resource coordinator
"Active substance abuse" exclusion was defined using the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) Criteria which is the gold standard for diagnosing substance use disorders is a cluster of cognitive, behavioral and physiological symptoms indicated that the individual continues using the substance despite significant substance related problems
The substances that were considered are listed below:
Overall, the diagnosis was based on pathological patterns of behaviors related to the use of the substance. Criteria that fit with overall groupings include impaired control, social impairment, risky use, and pharmacological criteria
Impaired control
Social impairment
Risky use
Pharmacologic criteria
Tolerance is signaled by requiring a markedly increased dose of substance to achieve the desired effect or markedly reduced effect when the usual dose is consumed
Withdrawal is a syndrome that occurs when blood or tissue concentrations of a substance decline in an individual who had maintained a prolonged heavy use of the substance
After developing withdrawal symptoms, the individual is likely to consume the substance to relieve the symptoms
Substance use disorders occur in a broad range of severity from mild to severe with severity based on number of symptom criteria endorsed.
Mild
Moderate
Severe
For our research purposes, our exclusion criteria included any individual who met criteria for mild, moderate, and severe substance use disorder
Those with severe cognitive or psychiatric impairments that preclude participation in group sessions will be excluded
Patients should not have any uncontrolled illness of any kind including ongoing or active infection
Subjects, who are not be able to comply with the safety monitoring requirements of the study. Those who miss more than half the sessions will be considered to not have completed the program
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| Name | Affiliation | Role |
|---|---|---|
| Heather N Bitar | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Educational Intervention | Other | Attend educational session |
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| Manipulative and Body-Based Intervention Procedure | Procedure | Undergo osteopathic manual treatments |
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| Occupational Therapy | Behavioral | Participate in occupational therapy |
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| Physical Activity | Other | Participate in physical activity |
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| Physical Therapy | Procedure | Participate in physical therapy |
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| Questionnaire Administration | Other | Ancillary studies |
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| Preliminary effect of the Functional Restoration Program in reducing pain (PSEQ) | The Pain Self-Efficacy Questionnaire (PSEQ) score: the PSEQ is a 10-item questionnaire, developed to assess the confidence people with ongoing pain have in performing activities while in pain. Scores can range from 0 - 60 and is done by simple addition. High PSEQ scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients. Higher scores (and a higher percentile) represent lower confidence to function with pain. | Pre-intervention, End of intervention (6 weeks), 3 months post-intervention |
| Preliminary effect of the Functional Restoration Program to restore physical function (ADL) | Activities of Daily Living (ADL): Medical Outcomes Study [MOS] subscale, Measures limitations in physical function activities, ranging from bathing and dressing to running. | Pre-intervention, End of intervention (6 weeks), 3 months post-intervention |
| Preliminary effect of the Functional Restoration Program to restore physical function (OARS) | Instrumental Activities of Daily Living (iADL): Older American Resources and Services [OARS] subscale, Measures ability to complete activities required to maintain independence, ranging from making telephone calls to money management. | Pre-intervention, End of intervention (6weeks), 3 months post-intervention |
| Preliminary effect of the Functional Restoration Program to restore physical function (6MWT) | Six minutes walk test (6MWT): The 6-min walk test is a submaximal exercise test that entails the measurement of distance (meter) walked over a span of 6 minutes. | Pre-intervention, End of intervention (6 weeks), 3 months post-intervention |
| Preliminary effect of the Functional Restoration Program to restore physical function (10mWT) | Ten meter walking test (10mWT): The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. | Pre-intervention, End of intervention (6 weeks), 3 months post-intervention |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D009788 | Occupational Therapy |
| D015444 | Exercise |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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