Hematopoietic and Lymphoid Cell NeoplasmNCT05036408
Cancer Pain Rehabilitation Program to Reduce Pain Related Distress, and Reliance of Pain Medication Through Multimodal Nonpharmacological Solutions
A study testing Behavioral, Psychological or Informational Intervention, Educational Intervention and Manipulative and Body-Based Intervention Procedure in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Behavioral, Psychological or Informational Intervention, Educational Intervention and Manipulative and Body-Based Intervention Procedure
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 41Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Cancer Pain Rehabilitation Program in Cancer Survivorship Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To test the feasibility of an interdisciplinary functional restoration program in cancer survivors with chronic pain and restoring physical function.
EXPLORATORY OBJECTIVE:
- 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.
- Being tested
- Behavioral, Psychological or Informational Intervention, Educational Intervention, Manipulative and Body-Based Intervention Procedure, Occupational Therapy, Physical Activity
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral, Psychological or Informational InterventionOther
Participate in group psychological intervention
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend educational session
Manipulative and Body-Based Intervention ProcedureProcedure or surgery
Also called Manipulative and Body-Based Intervention, Manipulative and Body-Based Methods, Manipulative and Body-Based Systems
Undergo osteopathic manual treatments
Occupational TherapyBehavioural
Also called OT
Participate in occupational therapy
Physical ActivityOther
Participate in physical activity
Physical TherapyProcedure or surgery
Also called Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure
Participate in physical therapy
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months from the intervention date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start21 Jul 2021
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heather N Bitar, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036408
- Sponsor's protocol ID
- 19530
- Other IDs
- NCI-2021-02052, 19530, P30CA033572
- Status last verified
- May 2024
- First submitted
- 1 Jul 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Pain Rehabilitation Program in Cancer Survivorship Feasibility Study
- ClinicalTrials.gov ID
- NCT05036408
- Acronym / sponsor ID
- 19530
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To test the feasibility of an interdisciplinary functional restoration program in cancer survivors with chronic pain and restoring physical function.
EXPLORATORY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (cancer pain rehabilitation program) | Experimental | 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 AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (41 listed)
- Patients who are less than the age of 18 or have active problems with addiction will be excluded:
- Impaired control
- Social impairment
- Risky use
- Pharmacologic criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral, Psychological or Informational InterventionParticipate in group psychological intervention | Other | Supportive care (cancer pain rehabilitation program) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend educational session | Other | Supportive care (cancer pain rehabilitation program) |
| Manipulative and Body-Based Intervention ProcedureAlso: Manipulative and Body-Based Intervention, Manipulative and Body-Based Methods, Manipulative and Body-Based SystemsUndergo osteopathic manual treatments | Procedure or surgery | Supportive care (cancer pain rehabilitation program) |
| Occupational TherapyAlso: OTParticipate in occupational therapy | Behavioural | Supportive care (cancer pain rehabilitation program) |
| Physical ActivityParticipate in physical activity | Other | Supportive care (cancer pain rehabilitation program) |
| Physical TherapyAlso: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy ProcedureParticipate in physical therapy | Procedure or surgery | Supportive care (cancer pain rehabilitation program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (cancer pain rehabilitation program) |
Primary outcome
Feasibility of Functional Restoration Program
Time frame: 24 months from the intervention date
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather N Bitar principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral, Psychological or Informational Intervention, Educational Intervention and Manipulative and Body-Based Intervention Procedure in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Functional Restoration Program (time frame: 24 months from the intervention date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.