Chronic Pain
Conditions
Keywords
Acceptance and Commitment Therapy, Cancer, Survivor, Group Based, Pain Management
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAcceptance 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.
OTHERTreatment 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Provision to sign and date the consent form 2. Stated willingness to comply with all study procedures and be available for the duration of the study 3. Be a male or female aged 18-100 4. Have pathology confirmed diagnosis of a solid tumor cancer 5. Be three or more months out from active cancer treatment (surgery, chemotherapy, and/or radiation) 6. Endorses experiencing pain for three or more months prior to eligibility screening 7. Indicates moderate to severe difficulties with pain interference as related to their cancer experience, with a score of 4 or higher on the pain interference item from the Chronic Pain Grading Questionnaire 8. Shows no evidence of cancer disease (NED) or with stable, chronic disease under watchful waiting 9. Fluent in English 10. Psychiatric stability as assessed by chart review and study personnel (e.g., not exhibiting symptoms consistent with diagnoses of serious mental illness such as active psychosis or mania)
Exclusion criteria
1. Having pain that can be solely attributed to a diagnosis outside of their cancer experience 2. Presenting with barriers to group participation (e.g., social anxiety) or when group-based provision of care would impede participant's treatment or that of other group members 3. Patients with a diagnosis of malignant neoplasm of the brain (ICD-10 C71) or malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system (ICD-10 C72).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | From baseline to 12 weeks post intervention | Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health. Min = 0 Max = 100 Higher scores are better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From baseline to end of intervention (weeks 1- 8) | 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. |
| The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | From baseline to end of intervention (weeks 1- 8) | 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). |
| The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | From baseline to end of intervention (weeks 1- 8) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 22 |
| Total | 50 |
Baseline characteristics
| Characteristic | Acceptance and Commitment Therapy | Treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 5 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 17 Participants | 37 Participants |
| Age, Continuous | 53 years | 56 years | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 21 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 21 Participants | 46 Participants |
| Region of Enrollment United States | 28 participants | 22 participants | 50 participants |
| Sex: Female, Male Female | 23 Participants | 17 Participants | 40 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 22 |
| other Total, other adverse events | 0 / 28 | 0 / 22 |
| serious Total, serious adverse events | 0 / 28 | 0 / 22 |
Outcome results
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.
Time frame: From baseline to 12 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Baseline | 23.9 units on a scale | Standard Deviation 34 |
| Intervention | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | 12 week | 41.7 units on a scale | Standard Deviation 39.9 |
| Control | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Baseline | 21.4 units on a scale | Standard Deviation 29.9 |
| Control | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | 12 week | 37.5 units on a scale | Standard Deviation 41.3 |
Comparison: Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.p-value: 0.8295% CI: [-31, 39]Regression, Linear
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.
Time frame: From baseline to 12 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Baseline | 62.6 units on a scale | Standard Deviation 18.3 |
| Intervention | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | 12-week follow up | 73.9 units on a scale | Standard Deviation 14.5 |
| Control | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | Baseline | 74.1 units on a scale | Standard Deviation 17.4 |
| Control | The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact] | 12-week follow up | 72.9 units on a scale | Standard Deviation 14.5 |
p-value: 0.0695% CI: [-0.7, 25]Regression, Linear
Comparison: Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.p-value: 0.05ANOVA
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.
Time frame: From baseline to end of intervention (weeks 1- 8)
Population: Data were only collected for the intervention group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | 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 | week1 therapy | 19 Participants |
| Intervention | 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 | week 2 therapy | 19 Participants |
| Intervention | 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 | week 3 therapy | 18 Participants |
| Intervention | 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 | week4 therapy | 18 Participants |
| Intervention | 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 | week5 therapy | 14 Participants |
| Intervention | 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 | week6 therapy | 18 Participants |
| Intervention | 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 | week7 therapy | 17 Participants |
| Intervention | 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 | week8 therapy | 17 Participants |
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.
Time frame: From baseline to end of intervention (weeks 1- 8)
Population: Limited to intervention group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 1 | 100 percentage of content checklist items | Standard Deviation 0 |
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 2 | 100 percentage of content checklist items | Standard Deviation 0 |
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 3 | 100 percentage of content checklist items | Standard Deviation 0 |
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 4 | 100 percentage of content checklist items | Standard Deviation 0 |
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 5 | 100 percentage of content checklist items | Standard Deviation 0 |
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 6 | 100 percentage of content checklist items | Standard Deviation 0 |
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 7 | 100 percentage of content checklist items | Standard Deviation 0 |
| Intervention | The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity] | Week 8 | 100 percentage of content checklist items | Standard Deviation 0 |
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).
Time frame: From baseline to end of intervention (weeks 1- 8)
Population: Adherence was only collected for the intervention arm that received the therapy sessions.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 1 | 4.4 units on a scale |
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 2 | 4.5 units on a scale |
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 3 | 4.6 units on a scale |
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 4 | 4.6 units on a scale |
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 5 | 4.6 units on a scale |
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 6 | 4.6 units on a scale |
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 7 | 4.8 units on a scale |
| Intervention | The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability] | Week 8 | 4.8 units on a scale |