Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

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.

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.

Acceptance and Commitment Therapy

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.

Treatment as Usual

Elissa Kolva, PhD

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.

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.

Participants will be randomized to the acceptance and commitment therapy intervention or to treatment as usual.

Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors

Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health.

Min = 0 Max = 100 Higher scores are better.

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.

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.

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).

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.

University of Colorado, Denver

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.

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.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Elissa Kolva, MD

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.

Baseline

12 week

Received acceptance and commitment therapy.

Intervention

Control

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

12-week follow up

week1 therapy

week 2 therapy

week 3 therapy

week4 therapy

week5 therapy

week6 therapy

week7 therapy

week8 therapy

Data were only collected for the intervention group.

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 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Adherence was only collected for the intervention arm that received the therapy sessions.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors	NCT03661840	Chronic Pain	Acceptance and ... Treatment as Us...	18 Years - 100 Years	University of Colorado, Denver
Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors	NCT03661840	Chronic Pain	Acceptance and ... Treatment as Us...	18 Years - 100 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for group based

Every month we try and update this database with for group based cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for group based

Every month we try and update this database with for group based cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for group based cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.