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NCT Number: NCT03661840

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

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.

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Key information

Conditions

Chronic Pain Agnosia Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision to sign and date the consent form
  • Stated willingness to comply with all study procedures and be available for the duration of the study
  • Be a male or female aged 18-100
  • Have pathology confirmed diagnosis of a solid tumor cancer
  • Be three or more months out from active cancer treatment (surgery, chemotherapy, and/or radiation)
  • Endorses experiencing pain for three or more months prior to eligibility screening
  • 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
  • Shows no evidence of cancer disease (NED) or with stable, chronic disease under "watchful waiting"
  • Fluent in English
  • 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

  • Having pain that can be solely attributed to a diagnosis outside of their cancer experience
  • 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
  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]

    Time frame: 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.

  2. The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]

    Time frame: From baseline to 12 weeks post intervention

    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.

Secondary outcomes

  1. 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

    Time frame: 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.

  2. The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]

    Time frame: 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).

  3. The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2018
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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