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A study to help manage chronic pain in cancer survivors through Acceptance and Commitment Therapy (ACT) after undergoing active cancer treatment, such as surgery, chemotherapy, and/or radiation.
This study attempts to apply effective pain management interventions from other chronic pain populations to those of cancer related populations. It will assess the ability of ACT to alleviate chronic cancer related pain and evaluate ease of implementation of treatment. Patients will be allocated to either the intervention group (ACT) or the control group, getting them the usual course of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Participants will receive both the ACT intervention and medication management that is given as usual treatment. |
|
| Treatment as Usual | Active Comparator | Treatment as usual will include ongoing provision of usual treatment options for pain management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | Intervention group participants will attend eight weekly, 90-minute, in person, group-based ACT sessions. Groups will be initiated with no more than 10 participants and no fewer than 6 participants. Sessions will include key theoretical ACT constructs and strategies as they relate to chronic pain. A licensed clinical psychologist or licensed clinical social worker trained in ACT will facilitate all sessions. Participants in the ACT intervention group will also continue to receive medication management and other behavioral management interventions that they would get as usual treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health. Min = 0 Max = 100 Higher scores are better. | From baseline to 12 weeks post intervention |
| The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess emotional wellbeing. Min=0 Max=100 Higher scores indicate better emotional wellbeing. | From baseline to 12 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Want to Use Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment Active Cancer Treatment | Feasibility of the intervention will be assessed through the collection of participant enrollment and adherence data throughout the intervention period and follow-up. We report the count of participants at each therapy session. Therapy sessions were held from baseline through week 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elissa Kolva, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acceptance and Commitment Therapy | Participants will receive both the ACT intervention and medication management that is given as usual treatment. Acceptance and Commitment Therapy: Intervention group participants will attend eight weekly, 90-minute, in person, group-based ACT sessions. Groups will be initiated with no more than 10 participants and no fewer than 6 participants. Sessions will include key theoretical ACT constructs and strategies as they relate to chronic pain. A licensed clinical psychologist or licensed clinical social worker trained in ACT will facilitate all sessions. Participants in the ACT intervention group will also continue to receive medication management and other behavioral management interventions that they would get as usual treatment. |
| FG001 | Treatment as Usual | Treatment as usual will include ongoing provision of usual treatment options for pain management. Treatment as Usual: Treatment as usual will include ongoing provision of usual treatment options for pain management. This includes continued medication management for cancer related chronic pain by prescribing providers, and access to supportive oncology services. It may also include other behavioral pain management such as physical therapy, acupuncture, or massage. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acceptance and Commitment Therapy | Participants will receive both the ACT intervention and medication management that is given as usual treatment. Acceptance and Commitment Therapy: Intervention group participants will attend eight weekly, 90-minute, in person, group-based ACT sessions. Groups will be initiated with no more than 10 participants and no fewer than 6 participants. Sessions will include key theoretical ACT constructs and strategies as they relate to chronic pain. A licensed clinical psychologist or licensed clinical social worker trained in ACT will facilitate all sessions. Participants in the ACT intervention group will also continue to receive medication management and other behavioral management interventions that they would get as usual treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health. Min = 0 Max = 100 Higher scores are better. | Posted | Mean | Standard Deviation | units on a scale | From baseline to 12 weeks post intervention |
|
|
Time from baseline to 12 week follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acceptance and Commitment Therapy | Participants will receive both the ACT intervention and medication management that is given as usual treatment. Acceptance and Commitment Therapy: Intervention group participants will attend eight weekly, 90-minute, in person, group-based ACT sessions. Groups will be initiated with no more than 10 participants and no fewer than 6 participants. Sessions will include key theoretical ACT constructs and strategies as they relate to chronic pain. A licensed clinical psychologist or licensed clinical social worker trained in ACT will facilitate all sessions. Participants in the ACT intervention group will also continue to receive medication management and other behavioral management interventions that they would get as usual treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elissa Kolva, MD | University of Colorado Hospital | 7208488090 | elissa.kolva@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 30, 2021 | Feb 22, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009369 | Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.
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|
| Treatment as Usual | Other | Treatment as usual will include ongoing provision of usual treatment options for pain management. This includes continued medication management for cancer related chronic pain by prescribing providers, and access to supportive oncology services. It may also include other behavioral pain management such as physical therapy, acupuncture, or massage. |
|
| From baseline to end of intervention (weeks 1- 8) |
| The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Acceptability of the intervention will be assessed through weekly ratings using a 5-point Likert scale for each session with intervention group members. The mean score is reported. Min = 1, Max = 5. Higher scores are better (i.e., indicate greater acceptability of the intervention). | From baseline to end of intervention (weeks 1- 8) |
| The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Fidelity of the treatment will be assessed through the use of a standardized checklist of core intervention components. It is measured as the mean percent of content checklist items presented to groups each week. | From baseline to end of intervention (weeks 1- 8) |
| BG001 | Treatment as Usual | Treatment as usual will include ongoing provision of usual treatment options for pain management. Treatment as Usual: Treatment as usual will include ongoing provision of usual treatment options for pain management. This includes continued medication management for cancer related chronic pain by prescribing providers, and access to supportive oncology services. It may also include other behavioral pain management such as physical therapy, acupuncture, or massage. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess emotional wellbeing. Min=0 Max=100 Higher scores indicate better emotional wellbeing. | Posted | Mean | Standard Deviation | units on a scale | From baseline to 12 weeks post intervention |
|
|
|
|
| Secondary | Number of Participants Who Want to Use Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment Active Cancer Treatment | Feasibility of the intervention will be assessed through the collection of participant enrollment and adherence data throughout the intervention period and follow-up. We report the count of participants at each therapy session. Therapy sessions were held from baseline through week 8. | Data were only collected for the intervention group. | Posted | Count of Participants | Participants | From baseline to end of intervention (weeks 1- 8) |
|
|
|
| Secondary | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Acceptability of the intervention will be assessed through weekly ratings using a 5-point Likert scale for each session with intervention group members. The mean score is reported. Min = 1, Max = 5. Higher scores are better (i.e., indicate greater acceptability of the intervention). | Adherence was only collected for the intervention arm that received the therapy sessions. | Posted | Mean | Full Range | units on a scale | From baseline to end of intervention (weeks 1- 8) |
|
|
|
| Secondary | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Fidelity of the treatment will be assessed through the use of a standardized checklist of core intervention components. It is measured as the mean percent of content checklist items presented to groups each week. | Limited to intervention group. | Posted | Mean | Standard Deviation | percentage of content checklist items | From baseline to end of intervention (weeks 1- 8) |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Treatment as Usual | Treatment as usual will include ongoing provision of usual treatment options for pain management. Treatment as Usual: Treatment as usual will include ongoing provision of usual treatment options for pain management. This includes continued medication management for cancer related chronic pain by prescribing providers, and access to supportive oncology services. It may also include other behavioral pain management such as physical therapy, acupuncture, or massage. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| ANOVA |
| 0.05 |
| Mean Difference (Final Values) |
| 0.61 |
| 2-Sided |
| Superiority |
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