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Cancer Pain Rehabilitation Program to Reduce Pain Related Distress, and Reliance of Pain Medication Through Multimodal Nonpharmacological Solutions

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral, Psychological or Informational Intervention
Educational Intervention
Manipulative and Body-Based Intervention Procedure
Occupational Therapy
Physical Activity
Physical Therapy
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • This study will be conducted in those with history of cancer in remission or with stable disease living with chronic pain greater than 6 months in duration
  • Cancer survivors or stable indolent cancer patients ages 18 or older living with chronic pain
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • Patients are required to have access to a computer with a camera and a reliable internet connection. The education lectures and psychotherapy group components of the program are facilitated via online Health Insurance Portability and Accountability Act (HIPPA) compliant platform
  • Eligible participants will be able to read and write and speak English and be motivated and able to commit to attending six consecutive weekly group and individual sessions

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:

      • Alcohol
      • Cannabis
      • Hallucinogens
      • Inhalants
      • Opioids
      • Sedatives (hypnotics or anxiolytics)
      • Stimulants
    • 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

    • The individual may express overall desire to cut down or regulate substance use and may report multiple unsuccessful efforts to decrease or discontinue use
    • The individual may spend a great deal of time obtaining the substance, using the substance, or recovering from its affects
    • The individual's daily activities revolve around the substance in some instances of more severe substance use disorder
    • Craving is manifested by intense desire or urge for the drug that may occur at any time
  • Social impairment

    • Recurrent substance use may result in failure to fulfill major role obligations at work, school, or home
    • The individual may continue substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance
    • Important social, occupational, or recreational activities may be given up or reduced because of substance use
    • The individual may withdraw from family activities and hobbies in order to use the substance
  • Risky use

    • Recurrent use in situations in which it is physically hazardous
    • The individual may continue substance use despite knowledge of having persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance
  • 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

      • Symptoms of tolerance or withdrawal occurring during appropriate medication treatment with prescribed medications are specifically not counted. However, prescription medications can be used inappropriately based on criteria above and substance use disorder can be correctly diagnosed when there are other symptoms of compulsive and drug seeking behavior
  • Substance use disorders occur in a broad range of severity from mild to severe with severity based on number of symptom criteria endorsed.

    • Mild

      • Presence of 2-3 symptoms
    • Moderate

      • Presence of 4-5 symptoms
    • Severe

      • Presence of 6-7 symptoms
  • 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

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (cancer pain rehabilitation program)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2021
Last Updated
May 15, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05036408
Brief Title
Cancer Pain Rehabilitation Program to Reduce Pain Related Distress, and Reliance of Pain Medication Through Multimodal Nonpharmacological Solutions
Official Title
Cancer Pain Rehabilitation Program in Cancer Survivorship Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (cancer pain rehabilitation program)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Behavioral, Psychological or Informational Intervention
Intervention Description
Participate in group psychological intervention
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Attend educational session
Intervention Type
Procedure
Intervention Name(s)
Manipulative and Body-Based Intervention Procedure
Other Intervention Name(s)
Manipulative and Body-Based Intervention, Manipulative and Body-Based Methods, Manipulative and Body-Based Systems
Intervention Description
Undergo osteopathic manual treatments
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Other Intervention Name(s)
OT
Intervention Description
Participate in occupational therapy
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
Participate in physical activity
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT
Intervention Description
Participate in physical therapy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of Functional Restoration Program
Description
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
Other Pre-specified Outcome Measures:
Title
Preliminary effect of the Functional Restoration Program in reducing pain (NSR)
Description
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
Title
Preliminary effect of the Functional Restoration Program in reducing pain (PSEQ)
Description
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
Title
Preliminary effect of the Functional Restoration Program to restore physical function (ADL)
Description
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
Title
Preliminary effect of the Functional Restoration Program to restore physical function (OARS)
Description
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
Title
Preliminary effect of the Functional Restoration Program to restore physical function (6MWT)
Description
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
Title
Preliminary effect of the Functional Restoration Program to restore physical function (10mWT)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This study will be conducted in those with history of cancer in remission or with stable disease living with chronic pain greater than 6 months in duration Cancer survivors or stable indolent cancer patients ages 18 or older living with chronic pain All subjects must have the ability to understand and the willingness to sign a written informed consent Patients are required to have access to a computer with a camera and a reliable internet connection. The education lectures and psychotherapy group components of the program are facilitated via online Health Insurance Portability and Accountability Act (HIPPA) compliant platform Eligible participants will be able to read and write and speak English and be motivated and able to commit to attending six consecutive weekly group and individual sessions 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: Alcohol Cannabis Hallucinogens Inhalants Opioids Sedatives (hypnotics or anxiolytics) Stimulants 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 The individual may express overall desire to cut down or regulate substance use and may report multiple unsuccessful efforts to decrease or discontinue use The individual may spend a great deal of time obtaining the substance, using the substance, or recovering from its affects The individual's daily activities revolve around the substance in some instances of more severe substance use disorder Craving is manifested by intense desire or urge for the drug that may occur at any time Social impairment Recurrent substance use may result in failure to fulfill major role obligations at work, school, or home The individual may continue substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance Important social, occupational, or recreational activities may be given up or reduced because of substance use The individual may withdraw from family activities and hobbies in order to use the substance Risky use Recurrent use in situations in which it is physically hazardous The individual may continue substance use despite knowledge of having persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance 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 Symptoms of tolerance or withdrawal occurring during appropriate medication treatment with prescribed medications are specifically not counted. However, prescription medications can be used inappropriately based on criteria above and substance use disorder can be correctly diagnosed when there are other symptoms of compulsive and drug seeking behavior Substance use disorders occur in a broad range of severity from mild to severe with severity based on number of symptom criteria endorsed. Mild Presence of 2-3 symptoms Moderate Presence of 4-5 symptoms Severe Presence of 6-7 symptoms 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather N Bitar
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather N. Bitar
Phone
626-416-1639
Email
hbitar@coh.org
First Name & Middle Initial & Last Name & Degree
Heather N. Bitar

12. IPD Sharing Statement

Learn more about this trial

Cancer Pain Rehabilitation Program to Reduce Pain Related Distress, and Reliance of Pain Medication Through Multimodal Nonpharmacological Solutions

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