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

NCT05036408 | Completed DMC

• 3 other identifiers: 19530NCI-2021-02052P30CA033572
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (6)

• Preliminary effect of the Functional Restoration Program in reducing pain (NSR)

  Pre-intervention , End of intervention (6 weeks), 3 months post-intervention

• Preliminary effect of the Functional Restoration Program in reducing pain (PSEQ)

  Pre-intervention, End of intervention (6 weeks), 3 months post-intervention

• Preliminary effect of the Functional Restoration Program to restore physical function (ADL)

  Pre-intervention, End of intervention (6 weeks), 3 months post-intervention

Study Arms (1)

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.

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

Interventions

Behavioral, Psychological or Informational Intervention OTHER

Participate in group psychological intervention

Supportive care (cancer pain rehabilitation program)

Educational Intervention OTHER

Attend educational session

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (cancer pain rehabilitation program)

Manipulative and Body-Based Intervention Procedure PROCEDURE

Undergo osteopathic manual treatments

Also known as: Manipulative and Body-Based Intervention, Manipulative and Body-Based Methods, Manipulative and Body-Based Systems

Supportive care (cancer pain rehabilitation program)

Occupational Therapy BEHAVIORAL

Participate in occupational therapy

Also known as: OT

Supportive care (cancer pain rehabilitation program)

Physical Activity OTHER

Participate in physical activity

Supportive care (cancer pain rehabilitation program)

Physical Therapy PROCEDURE

Participate in physical therapy

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Supportive care (cancer pain rehabilitation program)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (cancer pain rehabilitation program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Occupational Therapy; Exercise; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Heather N Bitar

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: September 5, 2021
• Study Start: July 21, 2021
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

US (1)