Preventing Persistent Pain and Reducing Depressive and Anxious Symptoms Following Mastectomy and Lumpectomy
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/13/2019 |
| Start Date: | June 21, 2015 |
| End Date: | November 22, 2017 |
The proposed study will be a pilot randomized controlled trial comparing treatment as usual
(TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention
(TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing
persistent post-operative pain. The ACT intervention is a single individual therapy session
scheduled two weeks following surgery. Potential participants will be recruited from the
University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be
recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the
study is 72 participants. Study measures will consist of self-report questionnaires and
medical record data. Data will be collected prior to surgery, one-week after surgery, and 3
months after surgery.
(TAU) to treatment as usual plus a brief Acceptance and Commitment Therapy (ACT) intervention
(TAU + ACT) with mastectomy and lumpectomy patients identified as at-risk for developing
persistent post-operative pain. The ACT intervention is a single individual therapy session
scheduled two weeks following surgery. Potential participants will be recruited from the
University of Iowa Breast Cancer Clinic. A sample size of n = 30 for each arm will be
recruited. An attrition rate of 20% is anticipated so the total N to be recruited for the
study is 72 participants. Study measures will consist of self-report questionnaires and
medical record data. Data will be collected prior to surgery, one-week after surgery, and 3
months after surgery.
Psychological interventions addressing depression, anxiety, and psychological approaches to
pain management in pre-surgical patients may serve to prevent the development of persistent
post-surgical pain, depression, and anxiety in at-risk individuals. Acceptance and Commitment
Therapy (ACT) is a psychological therapy that has been shown to be effective in minimizing
the impairing impact of chronic pain and in treating depression and anxiety. ACT is a
behavior therapy incorporating mindfulness, which aims to increase psychological flexibility
via facilitating psychological acceptance and committed action in the direction of one's
personally identified values. ACT has also shown promise in brief interventions, including a
one day ACT workshop with patients with comorbid migraine and depression. The current study
proposes to identify pre-operative breast cancer patients who are at increased risk for
developing persistent post-surgical pain and to offer a brief ACT intervention with the aim
of reducing the incidence of persistence post-surgical pain and psychological sequela.
pain management in pre-surgical patients may serve to prevent the development of persistent
post-surgical pain, depression, and anxiety in at-risk individuals. Acceptance and Commitment
Therapy (ACT) is a psychological therapy that has been shown to be effective in minimizing
the impairing impact of chronic pain and in treating depression and anxiety. ACT is a
behavior therapy incorporating mindfulness, which aims to increase psychological flexibility
via facilitating psychological acceptance and committed action in the direction of one's
personally identified values. ACT has also shown promise in brief interventions, including a
one day ACT workshop with patients with comorbid migraine and depression. The current study
proposes to identify pre-operative breast cancer patients who are at increased risk for
developing persistent post-surgical pain and to offer a brief ACT intervention with the aim
of reducing the incidence of persistence post-surgical pain and psychological sequela.
Inclusion criteria: 1) ≥18 years of age, 2) scheduled for mastectomy or lumpectomy for
breast cancer or DCIS, 3) identified to be "at risk" (per guidelines below).
At risk criteria: Psychological distress (elevated anxiety, depression, or pain
catastrophizing), under the age of 50, or with a pre-existing chronic pain condition.
Scores of 10 or above on the Generalized Anxiety Disorders 7-item scale or the Personal
Health Questionnaire Depression 8 item Scale will indicate elevated anxiety or depression.
A score of 30 or above on the Pain Catastrophizing Scale will indicate elevated
catastrophizing.
Exclusion Criteria:
1) language or cognitive barriers preventing completion of questionnaires, 2) severe
psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
We found this trial at
1
site
Click here to add this to my saved trials
