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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 : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Acceptance and Commitment Therapy Other: Treatment as Usual Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
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
Estimated Study Start Date : December 4, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
Contact: Ashley Pratt-Cordova 720-848-5521 ashley.pratt-cordova@ucdenver.edu
Contact: Emily Cox-Martin, PhD 720-848-8700 emily.cox-martin@ucdenver.edu

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Ashley Pratt-Cordova    720-848-5521    ashley.pratt-cordova@ucdenver.edu   
Principal Investigator: Emily Cox-Martin, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Emily Cox-Martin, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03661840     History of Changes
Other Study ID Numbers: 18-1102.cc
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Acceptance and Commitment Therapy
Cancer
Survivor
Group Based
Pain Management

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms