An interventional study of Behavioral, Psychological or Informational Intervention and Educational Intervention in Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
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Exclusion Criteria:
Patients who are less than the age of 18 or have active problems with addiction will be excluded:
The substances that were considered are listed below:
Impaired control
Social impairment
Risky use
Pharmacologic criteria
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
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.
Other: Behavioral, Psychological or Informational Intervention · Other: Educational Intervention · Procedure: Manipulative and Body-Based Intervention Procedure · Behavioral: Occupational Therapy · Other: Physical Activity · Procedure: Physical Therapy · Other: Questionnaire Administration
Participate in group psychological intervention
Attend educational session
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Undergo osteopathic manual treatments
Also known as: Manipulative and Body-Based Intervention, Manipulative and Body-Based Methods, Manipulative and Body-Based Systems
Participate in occupational therapy
Also known as: OT
Participate in physical activity
Participate in physical therapy
Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT
Ancillary studies
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.
Time frame: 24 months from the intervention date
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'.
Time frame: Pre-intervention , End of intervention (6 weeks), 3 months post-intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-intervention, End of intervention (6 weeks), 3 months post-intervention
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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