A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer
6 other identifiers
interventional
188
1 country
4
Brief Summary
The purpose of the research is to test the efficacy of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during cancer treatment, and to evaluate moderators and mediators of intervention effects. The intervention uses guided imagery, relaxation exercises, and nature sound recordings, self-administered via an MP3 player. The study will determine (1) if the intervention helps to control symptoms during chemotherapy, (2) if personal and clinical characteristics influence how well the intervention works, and (3) if the cognitive-behavioral strategies reduce markers of stress and inflammation found in blood and saliva.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Dec 2013
Longer than P75 for not_applicable pain
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2017
CompletedNovember 19, 2019
February 1, 2017
3.2 years
September 26, 2013
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Symptom Cluster Severity
3-weeks
Symptom Cluster Distress
3-weeks
Symptom Cluster Interference with Daily Life
3-weeks
Secondary Outcomes (3)
Symptom Cluster Severity
6- and 9-weeks
Symptom Cluster Distress
6- and 9-weeks
Symptom Cluster Interference with Daily Life
6- and 9-weeks
Other Outcomes (1)
Quality of Life
3-, 6-, 9-weeks
Study Arms (2)
Attention Control
OTHERStandard 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.
Cognitive-Behavioral Intervention
EXPERIMENTALStandard 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.
Interventions
Standard care + Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player.
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
SwedishAmerican Regional Cancer Center
Rockford, Illinois, 61104, United States
Mercy Health System
Janesville, Wisconsin, 53547-5003, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
ProHealth Care
Waukesha, Wisconsin, 53188, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristine Kwekkeboom, PhD., RN
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2013
First Posted
October 1, 2013
Study Start
December 1, 2013
Primary Completion
January 31, 2017
Study Completion
January 31, 2017
Last Updated
November 19, 2019
Record last verified: 2017-02