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

NCT ID: NCT05036408

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2024-05-06

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (cancer pain rehabilitation program)

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.

Group Type: EXPERIMENTAL

Behavioral, Psychological or Informational Intervention

Intervention Type: OTHER

Participate in group psychological intervention

Educational Intervention

Intervention Type: OTHER

Attend educational session

Manipulative and Body-Based Intervention Procedure

Intervention Type: PROCEDURE

Undergo osteopathic manual treatments

Occupational Therapy

Intervention Type: BEHAVIORAL

Participate in occupational therapy

Physical Activity

Intervention Type: OTHER

Participate in physical activity

Physical Therapy

Intervention Type: PROCEDURE

Participate in physical therapy

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Behavioral, Psychological or Informational Intervention

Participate in group psychological intervention

Intervention Type: OTHER

Educational Intervention

Attend educational session

Intervention Type: OTHER

Manipulative and Body-Based Intervention Procedure

Undergo osteopathic manual treatments

Intervention Type: PROCEDURE

Occupational Therapy

Participate in occupational therapy

Intervention Type: BEHAVIORAL

Physical Activity

Participate in physical activity

Intervention Type: OTHER

Physical Therapy

Participate in physical therapy

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Manipulative and Body-Based Intervention; Manipulative and Body-Based Methods; Manipulative and Body-Based Systems; OT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; PT

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather N Bitar

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2021-02052

Identifier Type: REGISTRY

Identifier Source: secondary_id

19530

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19530

Identifier Type: -

Identifier Source: org_study_id