Trial Outcomes & Findings for Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors (NCT NCT03661840)
NCT ID: NCT03661840
Last Updated: 2025-03-13
Results Overview
Use the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health. Min = 0 Max = 100 Higher scores are better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
From baseline to 12 weeks post intervention
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
Acceptance and Commitment Therapy
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
22
|
|
Overall Study
COMPLETED
|
28
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acceptance and Commitment Therapy for Chronic Pain in Cancer Survivors
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy
n=28 Participants
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
n=22 Participants
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
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Continuous
|
53 years
n=99 Participants
|
56 years
n=107 Participants
|
56 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
22 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 weeks post interventionUse the Medical Outcomes Study 36-Item Short Form Health Survey to assess physical health. Min = 0 Max = 100 Higher scores are better.
Outcome measures
| Measure |
Intervention
n=28 Participants
Received acceptance and commitment therapy.
|
Control
n=22 Participants
Treatment as usual
|
|---|---|---|
|
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]
Baseline
|
23.9 units on a scale
Standard Deviation 34.0
|
21.4 units on a scale
Standard Deviation 29.9
|
|
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]
12 week
|
41.7 units on a scale
Standard Deviation 39.9
|
37.5 units on a scale
Standard Deviation 41.3
|
PRIMARY outcome
Timeframe: From baseline to 12 weeks post interventionUse the Medical Outcomes Study 36-Item Short Form Health Survey to assess emotional wellbeing. Min=0 Max=100 Higher scores indicate better emotional wellbeing.
Outcome measures
| Measure |
Intervention
n=28 Participants
Received acceptance and commitment therapy.
|
Control
n=22 Participants
Treatment as usual
|
|---|---|---|
|
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]
12-week follow up
|
73.9 units on a scale
Standard Deviation 14.5
|
72.9 units on a scale
Standard Deviation 14.5
|
|
The Degree of Effectiveness of Acceptance and Commitment Therapy: [Impact]
Baseline
|
62.6 units on a scale
Standard Deviation 18.3
|
74.1 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: From baseline to end of intervention (weeks 1- 8)Population: Data were only collected for the intervention group.
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.
Outcome measures
| Measure |
Intervention
n=28 Participants
Received acceptance and commitment therapy.
|
Control
Treatment as usual
|
|---|---|---|
|
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
week1 therapy
|
19 Participants
|
—
|
|
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 2 therapy
|
19 Participants
|
—
|
|
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 3 therapy
|
18 Participants
|
—
|
|
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
week4 therapy
|
18 Participants
|
—
|
|
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
week5 therapy
|
14 Participants
|
—
|
|
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
week6 therapy
|
18 Participants
|
—
|
|
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
week7 therapy
|
17 Participants
|
—
|
|
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
week8 therapy
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: From baseline to end of intervention (weeks 1- 8)Population: Adherence was only collected for the intervention arm that received the therapy sessions.
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).
Outcome measures
| Measure |
Intervention
n=28 Participants
Received acceptance and commitment therapy.
|
Control
Treatment as usual
|
|---|---|---|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 1
|
4.4 units on a scale
Interval 3.0 to 5.0
|
—
|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 2
|
4.5 units on a scale
Interval 3.0 to 5.0
|
—
|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 3
|
4.6 units on a scale
Interval 4.0 to 5.0
|
—
|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 4
|
4.6 units on a scale
Interval 3.0 to 5.0
|
—
|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 5
|
4.6 units on a scale
Interval 3.0 to 5.0
|
—
|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 6
|
4.6 units on a scale
Interval 3.0 to 5.0
|
—
|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 7
|
4.8 units on a scale
Interval 4.0 to 5.0
|
—
|
|
The Degree to Which Patients Enjoy Using Acceptance and Commitment Therapy as a Method for Treating Chronic Pain Post Active Cancer Treatment: [Acceptability]
Week 8
|
4.8 units on a scale
Interval 4.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: From baseline to end of intervention (weeks 1- 8)Population: Limited to intervention group.
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.
Outcome measures
| Measure |
Intervention
n=28 Participants
Received acceptance and commitment therapy.
|
Control
Treatment as usual
|
|---|---|---|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 1
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 2
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 3
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 4
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 5
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 6
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 7
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
|
The Ability of Methodological Strategies Used to Monitor and Enhance the Reliability and Validity of ACT: [Fidelity]
Week 8
|
100 percentage of content checklist items
Standard Deviation 0
|
—
|
Adverse Events
Acceptance and Commitment Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place