Clinical Trial: Sleep and Endometrial Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain

Brief Summary: This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.

Detailed Summary: Despite continuing improvements in surgical procedures and ancillary care, post surgery pain continues to be a nearly universal patient experience following major operative procedures. Opioids provide considerable pain relief, but they have multiple adverse side effects and are not entirely effective. For cancer patients, uncontrolled postoperative pain can have a substantial negative effect on quality of life, can slow recovery, increase the likelihood of complications, and contribute to poorer postoperative outcomes. The identification of novel modifiable patient risk factors for post surgery pain that could become the target of presurgery interventions is thus an important goal. We will conduct a randomized, placebo-controlled, double-blind intervention trial design to evaluate the effects of an FDA approved hypnotic (zolpidem) on post surgery pain. Since presurgery psychological factors (e.g., heightened anxiety) are known to predict the severity of post surgical pain and may be associated with poor sleep, we will also assess psychological factors (with questionnaires) as well as sleep (using actigraphy) in order to determine their individual and combined impact on women's experiences of post surgery pain in this stressful clinical context. Aim 1: To determine the impact of zolpidem administered the night prior to endometrial cancer surgery on women's experiences of pain over the initial 7-10 day follow-up period after surgery using a double-blind placebo-controlled design (final n=128). Aim 2: To investigate psychological factors on the morning before surgery, as well as objective sleep variables on the night before surgery, as possible mediators of the beneficial effects of zolpidem on post surgery pain. Aim 3: To examine psychological factors, as well as sleep variables, assessed prior to the sleep intervention as possible moderators of the ameliorative effects of zolpidem on post surgery pain. The results of the proposed exploratory study would provide the p
Sponsor: University of Pittsburgh

Current Primary Outcome: Brief Pain Inventory (Short-form) [ Time Frame: at the clinical follow-up appointment approximately 7-10 days after surgery ]

Original Primary Outcome: Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. [ Time Frame: at the clinical follow-up appointment approximately 7-10 days after surgery ]

Current Secondary Outcome:

• Pain Severity Visual Analogue Scale [ Time Frame: each of the days following surgery until the clinical follow-up appointment ]
  Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain "as bad as it could be."
• Daily Analgesic Medication Consumption (Morphine Equivalency) [ Time Frame: daily from the day of surgery until the clinical follow-up appointment ]
  Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.

Original Secondary Outcome:

• Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). [ Time Frame: each of the days following surgery until the clinical follow-up appointment ]
• Analgesic medication consumption will be calculated (morphine equivalency) on a daily basis using data down loaded from the PCA pump supplemented by information from clinical charts and patient self report on the daily diary form. [ Time Frame: daily from the day of surgery until the clinical follow-up appointment ]

Dates:
Date Received: July 8, 2009
Date Started: July 2009
Date Completion:
Last Updated: April 4, 2014
Last Verified: April 2014