Cognitive CopingNCT07869420
Evaluating Feasibility and Acceptability of Pain Education
A study testing Cancer Pain 101 and Pharmacotherapy Informational Packet in people with Cognitive Coping and Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to implement a healthy, non-invasive therapeutic alternative for managing cancer-related pain in chronic cancer patients (Cancer Pain 101). This pilot trial will investigate the feasibility and effectiveness of implementing this approach through a single session, with the goal of helping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Coping, Cancer
- What is being tested?
- Cancer Pain 101 and Pharmacotherapy Informational Packet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 30 Nov 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
- Age > 18 years old
- Have chronic pain related to cancer (> 4/10 average pain score in the past two weeks)
- Receiving active cancer treatment or recently completed treatment (within the past 3 months)
Who cannot join
- Inability to speak/read English
- Cognitive impairment significant enough to impair participation in study procedures (e.g. delirium/dementia)
Trial locations and contacts
1 site in 1 country.
United States1 site
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Evaluating the Feasibility and Acceptability of a Single-session Pain Education Class for Patients With Cancer and Pain
The purpose of this study is to implement a healthy, non-invasive therapeutic alternative for managing cancer-related pain in chronic cancer patients (Cancer Pain 101). This pilot trial will investigate the feasibility and effectiveness of implementing this approach through a single session, with the goal of helping patients improve their pain control and pain-related quality of life.
Read the detailed description
This study is a pilot trial designed to assess the feasibility and efficacy of a single-session cognitive behavioral therapy for pain (CBT) intervention integrated with pharmacotherapy education. Specifically, the study will implement a 90-minute, single-session intervention combining CBT and pharmacotherapy education to help patients self-manage their chronic cancer pain and improve their overall quality of life.
The trial will consist of three aims. Aims 1 and 2 will begin with the pilot trial, Cancer Pain 101. This single-session intervention will assess the feasibility and acceptability of delivering a traditional CBT-based intervention to patients with chronic cancer pain. For Aim 2, the investigator will implement Cancer Pain 101, which combines traditional CBT with pharmacotherapy education, as a behavioral intervention to assess its potential benefits on patients' pain management and quality of life.
For Aim 3, a randomized pilot trial will be conducted to further assess the feasibility of Cancer Pain 101 as an alternative approach to traditional CBT. Participants will be randomized to one of two cohorts (Cohort A or Cohort B). Participants randomized to Cohort A will follow the same process as Aim 1 and will attend a single-session Cancer Pain 101 intervention class. Participants randomized to Cohort B will serve as the control group and will receive an educational packet containing cancer pain and pain-related CBT educational materials from the American Cancer Society (ACS).
Participants in both cohorts will be asked to complete questionnaires to assess their experiences with the intervention or educational materials, as well as changes in pain management and quality of life over the course of the study.
The surveys administers are Pain Catastrophizing Scale (PCS), Pain Self-Efficacy (PSEQ), System Usability Scale (SUS), and Patient Reported Outcome Measurement Information System (PROMIS) to measure patients mood and sleep. The PCS scale is a 13-item self report measure assessed on a 5-point Likert scale 0= Not at all and 4= All the time. The Pain Self-Efficacy scale is a 10-item self report measure of a 7-point Likert scale 0= Less self-efficacy and 6= More self-efficacy. The System Usability Scale is measured on a 5-point Likert scale. PROMIS is a short answer form measured on a 5-point Likert scale. Higher scores indicate higher symptom severity.
- Conditions
- Cognitive Coping, Cancer
- Being tested
- Cancer Pain 101, Pharmacotherapy Informational Packet
- Keywords
- CBT, Cancer Pain 101
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Pain 101Other
This is a 90-minute virtual class led by the Principal Investigator (PI) and the investigational team. The class will cover all six traditional pain-focused cognitive behavioral therapy (CBT) modules referenced in the study protocol. Due to the limited session time, all educational materials and references used during the class are standard-of-care resources.
Pharmacotherapy Informational PacketOther
Patients randomized to Cohort B will receive a informational packet of cancer-pain educational materials provided by the American Cancer Society.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Trial | Active comparator | During the pilot trial, 60 evaluable patients with chronic cancer-related pain will participate in a 90-minute Cancer Pain 101 class focused on behavioral, non-invasive strategies for managing cancer-related pain. Surveys will be completed at baseline and at 2- and 4-week follow-ups. The first outcome will assess the feasibility, acceptability, and perceived usefulness of the intervention. For the second outcome, researchers will use data collected during Aim 1 to examine changes in pain severity, opioid use, pain management, and quality of life compared with baseline measures. The goal is to determine whether participation in Cancer Pain 101 is associated with improved pain control, reduced opioid use, and improved pain-related quality of life. Receives: Other: Cancer Pain 101 |
| Intervention Group Cohort A Cancer Pain 101 | Experimental | Aim 3 of this trial will serve as a randomized pilot trial consisting of two cohorts and will include 60 evaluable patients total amongst the two cohorts. Participants randomized to Cohort A will attend a 90-minute Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life. Receives: Other: Cancer Pain 101 |
| Intervention Group Cohort B CBT | Experimental | Cohort B will serve as the control group. Patients randomized to this cohort will receive an informational packet containing educational materials on cancer-related pain from the American Cancer Society (ACS). Participants in Cohort B will not attend the Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life. Receives: Other: Pharmacotherapy Informational Packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who engage in Cancer Pain 101 intervention attendance.
The primary aim of this study is to determine the feasibility of the Cancer Pain 101 behavioral intervention. Feasibility will be assessed based on several measures, including primarily the proportion of patients who attend the telehealth Cancer Pain 101 intervention, in addition to time to accrual, participation rates, and survey completion rates.
Feasibility will be considered demonstrated if more than 70% of enrolled patients participate in the telehealth intervention.
Measured: 1 Year
Percentage of Patient Who reported acceptability of The Cancer Pain 101 Intervention.
Acceptability will be assessed using participant questionnaire responses. The intervention will be considered acceptable if more than 80% of participants rate the questionnaire items greater than 4 out of 5.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start22 Jul 2024
- Primary completion9 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive CopingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 90-Min Single-Session introducing pain education and cognitive behavioral therapy.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Azizoddin Desiree, PsyD, Principal investigator, Dana Farber Cancer Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869420
- Sponsor's protocol ID
- Cancer Pain 101 (Pilot)
- Other IDs
- U54GM104938, K08CA266937, P30CA225520
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Acceptability of a Single-session Pain Education Class for Patients With Cancer and Pain
- ClinicalTrials.gov ID
- NCT07869420
- Acronym / sponsor ID
- Cancer Pain 101 (Pilot)
- Conditions
- Cognitive Coping, Cancer
- Keywords
- CBT, Cancer Pain 101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), National Cancer Institute (NCI)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 9 Oct 2026 (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.
The purpose of this study is to implement a healthy, non-invasive therapeutic alternative for managing cancer-related pain in chronic cancer patients (Cancer Pain 101). This pilot trial will investigate the feasibility and effectiveness of implementing this approach through a single session, with the goal of helping patients improve their pain control and pain-related quality of life.
Detailed description
This study is a pilot trial designed to assess the feasibility and efficacy of a single-session cognitive behavioral therapy for pain (CBT) intervention integrated with pharmacotherapy education. Specifically, the study will implement a 90-minute, single-session intervention combining CBT and pharmacotherapy education to help patients self-manage their chronic cancer pain and improve their overall quality of life.
The trial will consist of three aims. Aims 1 and 2 will begin with the pilot trial, Cancer Pain 101. This single-session intervention will assess the feasibility and acceptability of delivering a traditional CBT-based intervention to patients with chronic cancer pain. For Aim 2, the investigator will implement Cancer Pain 101, which combines traditional CBT with pharmacotherapy education, as a behavioral intervention to assess its potential benefits on patients' pain management and quality of life.
For Aim 3, a randomized pilot trial will be conducted to further assess the feasibility of Cancer Pain 101 as an alternative approach to traditional CBT. Participants will be randomized to one of two cohorts (Cohort A or Cohort B). Participants randomized to Cohort A will follow the same process as Aim 1 and will attend a single-session Cancer Pain 101 intervention class. Participants randomized to Cohort B will serve as the control group and will receive an educational packet containing cancer pain and pain-related CBT educational materials from the American Cancer Society (ACS).
Participants in both cohorts will be asked to complete questionnaires to assess their experiences with the intervention or educational materials, as well as changes in pain management and quality of life over the course of the study.
The surveys administers are Pain Catastrophizing Scale (PCS), Pain Self-Efficacy (PSEQ), System Usability Scale (SUS), and Patient Reported Outcome Measurement Information System (PROMIS) to measure patients mood and sleep. The PCS scale is a 13-item self report measure assessed on a 5-point Likert scale 0= Not at all and 4= All the time. The Pain Self-Efficacy scale is a 10-item self report measure of a 7-point Likert scale 0= Less self-efficacy and 6= More self-efficacy. The System Usability Scale is measured on a 5-point Likert scale. PROMIS is a short answer form measured on a 5-point Likert scale. Higher scores indicate higher symptom severity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 90-Min Single-Session introducing pain education and cognitive behavioral therapy.
| Arm | Type | Receives |
|---|---|---|
| Pilot Trial | Active comparator | Other: Cancer Pain 101During the pilot trial, 60 evaluable patients with chronic cancer-related pain will participate in a 90-minute Cancer Pain 101 class focused on behavioral, non-invasive strategies for managing cancer-related pain. Surveys will be completed at baseline and at 2- and 4-week follow-ups. The first outcome will assess the feasibility, acceptability, and perceived usefulness of the intervention. For the second outcome, researchers will use data collected during Aim 1 to examine changes in pain severity, opioid use, pain management, and quality of life compared with baseline measures. The goal is to determine whether participation in Cancer Pain 101 is associated with improved pain control, reduced opioid use, and improved pain-related quality of life. |
| Intervention Group Cohort A Cancer Pain 101 | Experimental | Other: Cancer Pain 101Aim 3 of this trial will serve as a randomized pilot trial consisting of two cohorts and will include 60 evaluable patients total amongst the two cohorts. Participants randomized to Cohort A will attend a 90-minute Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life. |
| Intervention Group Cohort B CBT | Experimental | Other: Pharmacotherapy Informational PacketCohort B will serve as the control group. Patients randomized to this cohort will receive an informational packet containing educational materials on cancer-related pain from the American Cancer Society (ACS). Participants in Cohort B will not attend the Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Have chronic pain related to cancer (> 4/10 average pain score in the past two weeks)
- Receiving active cancer treatment or recently completed treatment (within the past 3 months)
Key exclusion criteria (2 listed)
- Inability to speak/read English
- Cognitive impairment significant enough to impair participation in study procedures (e.g. delirium/dementia)
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 |
|---|---|---|
| Cancer Pain 101This is a 90-minute virtual class led by the Principal Investigator (PI) and the investigational team. The class will cover all six traditional pain-focused cognitive behavioral therapy (CBT) modules referenced in the study protocol. Due to the limited session time, all educational materials and references used during the class are standard-of-care resources. | Other | Intervention Group Cohort A Cancer Pain 101, Pilot Trial |
| Pharmacotherapy Informational PacketPatients randomized to Cohort B will receive a informational packet of cancer-pain educational materials provided by the American Cancer Society. | Other | Intervention Group Cohort B CBT |
Primary outcome
Percentage of Patients Who engage in Cancer Pain 101 intervention attendance.
Time frame: 1 Year
The primary aim of this study is to determine the feasibility of the Cancer Pain 101 behavioral intervention. Feasibility will be assessed based on several measures, including primarily the proportion of patients who attend the telehealth Cancer Pain 101 intervention, in addition to time to accrual, participation rates, and survey completion rates. Feasibility will be considered demonstrated if more than 70% of enrolled patients participate in the telehealth intervention.
Percentage of Patient Who reported acceptability of The Cancer Pain 101 Intervention.
Time frame: 1 Year
Acceptability will be assessed using participant questionnaire responses. The intervention will be considered acceptable if more than 80% of participants rate the questionnaire items greater than 4 out of 5.
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 9 Oct 2026.
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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.
Azizoddin Desiree, PsyD principal investigator
Dana Farber Cancer Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Pain 101 and Pharmacotherapy Informational Packet in people with Cognitive Coping and Cancer, run by University of Oklahoma 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 3 inclusion and 2 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 9 Oct 2026. 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?
Percentage of Patients Who engage in Cancer Pain 101 intervention attendance. (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 9 Oct 2026.