Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT03661840|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Acceptance and Commitment Therapy Other: Treatment as Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||444 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2023|
Experimental: Acceptance and Commitment Therapy
Participants will receive both the ACT intervention and medication management that is given as usual treatment.
Behavioral: 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.
Active Comparator: Treatment as Usual
Treatment as usual will include ongoing provision of usual treatment options for pain management.
Other: 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.
- The degree of effectiveness of Acceptance and Commitment Therapy: [Impact] [ Time Frame: From baseline to 12 weeks post intervention, over 3 years. ]Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health.
- The degree of effectiveness of Acceptance and Commitment Therapy: [Impact] [ Time Frame: From baseline to 12 weeks post intervention, over 3 years. ]Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess emotional wellbeing.
- The desire for patients to want use Acceptance and Commitment Therapy as a method for treating chronic pain post active cancer treatment: [Feasibility] [ Time Frame: From baseline to 12 weeks post intervention, over 3 years. ]Feasibility of the intervention will be assessed through the collection of participant enrollment and adherence data throughout the intervention period and follow-up.
- The amount of patients who enjoy using Acceptance and Commitment Therapy as a method for treating chronic pain post active cancer treatment: [Acceptability] [ Time Frame: From baseline to 12 weeks post intervention, over 3 years. ]Acceptability of the intervention will be assessed through semi-structured qualitative interviews and weekly ratings of acceptability for each session with intervention group members.
- The ability of methodological strategies used to monitor and enhance the reliability and validity of ACT: [Fidelity] [ Time Frame: From baseline to 12 weeks post intervention, over 3 years. ]Fidelity of the treatment will be measured through observation and the use of standardized checklist of core intervention components.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661840
|Contact: Emily Cox-Martin, PhDemail@example.com|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Ashley Pratt-Cordova 720-848-5521 firstname.lastname@example.org|
|Principal Investigator: Emily Cox-Martin, PhD|
|Principal Investigator:||Emily Cox-Martin, PhD||University of Colorado, Denver|