PainNCT01954420
A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer
A study testing Cognitive-Behavioral Intervention in people with Pain and Fatigue, run by University of Wisconsin, Madison at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Fatigue, Sleep Disturbance
- What is being tested?
- Cognitive-Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2013to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Mercy Health System
Janesville, Wisconsin, 53547-5003
University of Wisconsin
Madison, Wisconsin, 53792
SwedishAmerican Regional Cancer Center
Rockford, Illinois, 61104
ProHealth Care
Waukesha, Wisconsin, 53188
About this study
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.
Read the detailed description
Co-occuring pain, fatigue, and sleep disturbance is a common symptom cluster among patients with advanced cancer, diminishing functional status and quality of life. Cognitive-behavioral (CB) strategies (e.g., relaxation, distraction, and imagery) are effective treatments for each of these symptoms, and provide a logical choice in managing all three co-occurring symptoms. CB strategies are thought to work psychologically by reducing anxiety and stress, improving expectations for symptom outcomes, and enhancing perceptions of personal control. Recent research also suggests a physiologic pathway, in which CB strategies attenuate dysregulation in stress hormones and reduce proinflammatory cytokines that contribute to symptom exacerbation. CB strategies are not equally effective for all patients, with differences based on individual preferences and skills and concurrent symptoms. Thus, training in a single strategy is not sufficient. Our previous work demonstrates feasibility and initial efficacy of a patient-controlled cognitive-behavioral (PC-CB) intervention in which patients receive information about their symptoms and rationale for CB strategies, then self-administer their selection of various relaxation, distraction, and imagery strategies via MP3 player, using the CB strategies at whatever time and place they are needed. This brief intervention was designed to be mindful of the high symptom burden, unpredictable treatment course, and often short life expectancy of persons with advanced cancer. The purpose of this study is to test efficacy of the PC-CB intervention in a randomized controlled trial and to test moderators and mediators of intervention effects. The specific aims are (1) to test efficacy of the PC-CB intervention on severity, distress, and interference with daily life from the pain, fatigue, sleep disturbance symptom cluster, (2) to test proposed moderators (imaging ability, concurrent symptoms) of PC-CB intervention effects, (3) to test psychological mediators (anxiety, stress, outcome expectancy, perceived control) of PC-CB intervention effects, and (4) to explore two types of physiological mediators (neuroendocrine stress hormones and indices of inflammation) of PC-CB intervention effects. A sample of 198 adults receiving chemotherapy for advanced breast, lung, colorectal, prostate, gynecologic or other solid tumor cancers and experiencing pain, fatigue, and sleep disturbance will be recruited. Patients randomized to the PC-CB intervention will receive a brief training session and instructions to use the recorded CB strategies during 9-weeks of cancer treatment. Patients randomized to attention control will receive instructions to use cancer educational recordings over the same period. Measures of symptom severity and distress, symptom interference with daily life, and proposed psychological and physiologic mediating variables will be completed at baseline and the 3-week (primary) time point. Symptom outcome measures will be repeated at 6- and 9-week (secondary) time points to evaluate longer term treatment effects.
- Conditions
- Pain, Fatigue, Sleep Disturbance, Cancer
- Being tested
- Cognitive-Behavioral Intervention, Attention Control
- Keywords
- Pain, Fatigue, Sleep, Cancer, Relaxation, Distraction, Symptoms
- Medical subject headings
- Pain, Fatigue, Parasomnias, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral InterventionBehavioural
Standard care + Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player.
Attention ControlOther
Standard care + Cancer education
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Other | 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. Receives: Other: Attention Control |
| Cognitive-Behavioral Intervention | Experimental | 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. Receives: Behavioral: Cognitive-Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Cluster Severity
Measured: 3-weeks
Symptom Cluster Distress
Measured: 3-weeks
Symptom Cluster Interference with Daily Life
Measured: 3-weeks
Secondary outcomes (3)
Symptom Cluster Severity
Measured: 6- and 9-weeks
Symptom Cluster Distress
Measured: 6- and 9-weeks
Symptom Cluster Interference with Daily Life
Measured: 6- and 9-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startDec 2013
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Kristine Kwekkeboom, PhD., RN, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954420
- Sponsor's protocol ID
- 2013-0733
- Other IDs
- OS11322, R01NR013468-01A1, 2013-0733, A549000, NUR\RESEARCH\NURSNG RES, NCI-2013-02325
- Status last verified
- Feb 2017
- First submitted
- 26 Sep 2013
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer
- ClinicalTrials.gov ID
- NCT01954420
- Acronym / sponsor ID
- 2013-0733
- Conditions
- Pain, Fatigue, Sleep Disturbance, Cancer
- Keywords
- Pain, Fatigue, Sleep, Cancer, Relaxation, Distraction, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Dec 2013
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Co-occuring pain, fatigue, and sleep disturbance is a common symptom cluster among patients with advanced cancer, diminishing functional status and quality of life. Cognitive-behavioral (CB) strategies (e.g., relaxation, distraction, and imagery) are effective treatments for each of these symptoms, and provide a logical choice in managing all three co-occurring symptoms. CB strategies are thought to work psychologically by reducing anxiety and stress, improving expectations for symptom outcomes, and enhancing perceptions of personal control. Recent research also suggests a physiologic pathway, in which CB strategies attenuate dysregulation in stress hormones and reduce proinflammatory cytokines that contribute to symptom exacerbation. CB strategies are not equally effective for all patients, with differences based on individual preferences and skills and concurrent symptoms. Thus, training in a single strategy is not sufficient. Our previous work demonstrates feasibility and initial efficacy of a patient-controlled cognitive-behavioral (PC-CB) intervention in which patients receive information about their symptoms and rationale for CB strategies, then self-administer their selection of various relaxation, distraction, and imagery strategies via MP3 player, using the CB strategies at whatever time and place they are needed. This brief intervention was designed to be mindful of the high symptom burden, unpredictable treatment course, and often short life expectancy of persons with advanced cancer. The purpose of this study is to test efficacy of the PC-CB intervention in a randomized controlled trial and to test moderators and mediators of intervention effects. The specific aims are (1) to test efficacy of the PC-CB intervention on severity, distress, and interference with daily life from the pain, fatigue, sleep disturbance symptom cluster, (2) to test proposed moderators (imaging ability, concurrent symptoms) of PC-CB intervention effects, (3) to test psychological mediators (anxiety, stress, outcome expectancy, perceived control) of PC-CB intervention effects, and (4) to explore two types of physiological mediators (neuroendocrine stress hormones and indices of inflammation) of PC-CB intervention effects. A sample of 198 adults receiving chemotherapy for advanced breast, lung, colorectal, prostate, gynecologic or other solid tumor cancers and experiencing pain, fatigue, and sleep disturbance will be recruited. Patients randomized to the PC-CB intervention will receive a brief training session and instructions to use the recorded CB strategies during 9-weeks of cancer treatment. Patients randomized to attention control will receive instructions to use cancer educational recordings over the same period. Measures of symptom severity and distress, symptom interference with daily life, and proposed psychological and physiologic mediating variables will be completed at baseline and the 3-week (primary) time point. Symptom outcome measures will be repeated at 6- and 9-week (secondary) time points to evaluate longer term treatment effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Other | Other: Attention ControlStandard 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 | Experimental | Behavioral: Cognitive-Behavioral InterventionStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral InterventionStandard care + Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player. | Behavioural | Cognitive-Behavioral Intervention |
| Attention ControlStandard care + Cancer education | Other | Attention Control |
Primary outcome
Symptom Cluster Severity
Time frame: 3-weeks
Symptom Cluster Distress
Time frame: 3-weeks
Symptom Cluster Interference with Daily Life
Time frame: 3-weeks
3 secondary outcomes
Symptom Cluster Severity
Time frame: 6- and 9-weeks
Symptom Cluster Distress
Time frame: 6- and 9-weeks
Symptom Cluster Interference with Daily Life
Time frame: 6- and 9-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Kwekkeboom, PhD., RN principal investigator
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Intervention in people with Pain and Fatigue, run by University of Wisconsin, Madison at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Cluster Severity (time frame: 3-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.