Pain and Fatigue Study
Completed · Not applicable
Conditions studied: Carcinoma
In brief
Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care. When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following: 1. The primary outcome--total number of symptoms reported; 2. The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and 3. Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.
Key facts
- Study ID
- NCT00006253
- Run by
- Michigan State University
- People needed
- 350
- Starts
- 2003-03-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2011-12-07
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 21 years of age or older
- solid tumor cancer diagnosis
- receiving chemotherapy treatment
- advanced cancer
- family caregiver
You may not qualify if…
- Emotional or psychology disorder for which patient is receiving treatment
- does not speak English
- does not have access to a telephone
- difficulty hearing on the telephone
Where it is running
- Michigan State University — East Lansing, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.