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Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Primary Purpose

Chronic Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Treatment as Usual
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Acceptance and Commitment Therapy, Cancer, Survivor, Group Based, Pain Management

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance and Commitment Therapy

Treatment as Usual

Arm Description

Participants will receive both the ACT intervention and medication management that is given as usual treatment.

Treatment as usual will include ongoing provision of usual treatment options for pain management.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

The desire for patients to want use Acceptance and Commitment Therapy as a method for treating chronic pain post active cancer treatment: [Feasibility]
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]
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]
Fidelity of the treatment will be measured through observation and the use of standardized checklist of core intervention components.

Full Information

First Posted
September 5, 2018
Last Updated
February 14, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03661840
Brief Title
Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors
Official Title
Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Acceptance and Commitment Therapy, Cancer, Survivor, Group Based, Pain Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy
Arm Type
Experimental
Arm Description
Participants will receive both the ACT intervention and medication management that is given as usual treatment.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual will include ongoing provision of usual treatment options for pain management.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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 Measure Information:
Title
The degree of effectiveness of Acceptance and Commitment Therapy: [Impact]
Description
Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health.
Time Frame
From baseline to 12 weeks post intervention, over 3 years.
Title
The degree of effectiveness of Acceptance and Commitment Therapy: [Impact]
Description
Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess emotional wellbeing.
Time Frame
From baseline to 12 weeks post intervention, over 3 years.
Secondary Outcome Measure Information:
Title
The desire for patients to want use Acceptance and Commitment Therapy as a method for treating chronic pain post active cancer treatment: [Feasibility]
Description
Feasibility of the intervention will be assessed through the collection of participant enrollment and adherence data throughout the intervention period and follow-up.
Time Frame
From baseline to 12 weeks post intervention, over 3 years.
Title
The amount of patients who enjoy using Acceptance and Commitment Therapy as a method for treating chronic pain post active cancer treatment: [Acceptability]
Description
Acceptability of the intervention will be assessed through semi-structured qualitative interviews and weekly ratings of acceptability for each session with intervention group members.
Time Frame
From baseline to 12 weeks post intervention, over 3 years.
Title
The ability of methodological strategies used to monitor and enhance the reliability and validity of ACT: [Fidelity]
Description
Fidelity of the treatment will be measured through observation and the use of standardized checklist of core intervention components.
Time Frame
From baseline to 12 weeks post intervention, over 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elissa Kolva, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

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