- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01954420
A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Rockford, Illinois, United States, 61104
- SwedishAmerican Regional Cancer Center
-
-
Wisconsin
-
Janesville, Wisconsin, United States, 53547-5003
- Mercy Health System
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
Waukesha, Wisconsin, United States, 53188
- ProHealth Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be 18 years of age or older.
- Have a diagnosis of advanced (metastatic or recurrent) lung, breast, colorectal, prostate, gynecologic or other solid tumor cancer.
- Be receiving outpatient chemotherapy.
- Report all three symptoms (pain, fatigue, and sleep disturbance) as present in the past week with worst severity rating ≥ 3 (0-10 scale) for at least two of the three symptoms -
Exclusion Criteria:
- Pain that is post-operative (< 3 months since surgery) or severe neuropathic pain.
- Hospitalized for psychiatric reasons within the past 3 months.
- Unable to read, write, or understand English, or otherwise unable to complete study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Attention Control
Standard care + cancer education Participants receive a single session with a research nurse to discuss the importance of understanding cancer and cancer treatment strategies, and to introduce educational recordings available on an MP3 player. The educational recordings provide a selection of publicly available American Cancer Society patient information materials addressing topics related to cancer and cancer treatment strategies. Participants are asked to listen to at least one recording per day, or more frequently as desired. |
Standard care + Cancer education
|
Experimental: Cognitive-Behavioral Intervention
Standard care + Patient-Controlled Cognitive Behavioral Intervention Participants will receive a single training session with a research nurse including: 1) Information about the causes of cancer-related pain, fatigue, and sleep disturbance. 2) An explanation of how cognitive-behavioral interventions may affect symptoms. 3) Review of the specific cognitive-behavioral strategies provided on the MP3 player. 4) Individualized recommendations for using the cognitive-behavioral strategies. The nurse interventionist and patient will develop a written plan for practicing the strategies with recommendations to use a strategy at least once a day, or more frequently as needed. |
Standard care + Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom Cluster Severity
Time Frame: 3-weeks
|
3-weeks
|
Symptom Cluster Distress
Time Frame: 3-weeks
|
3-weeks
|
Symptom Cluster Interference with Daily Life
Time Frame: 3-weeks
|
3-weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom Cluster Severity
Time Frame: 6- and 9-weeks
|
6- and 9-weeks
|
Symptom Cluster Distress
Time Frame: 6- and 9-weeks
|
6- and 9-weeks
|
Symptom Cluster Interference with Daily Life
Time Frame: 6- and 9-weeks
|
6- and 9-weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: 3-, 6-, 9-weeks
|
3-, 6-, 9-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristine Kwekkeboom, PhD., RN, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0733 (Other Identifier: Institutional Review Board)
- OS11322 (Other Identifier: UW Carbone Cancer Center)
- R01NR013468-01A1 (U.S. NIH Grant/Contract)
- A549000 (Other Identifier: UW Madison)
- NUR\RESEARCH\NURSNG RES (Other Identifier: UW Madison)
- NCI-2013-02325 (Registry Identifier: NCI Trial ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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