Advanced CancerNCT03285633
Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer
A study testing Cognitive Behavioral Mutli-Symptom management(CBT) in people with Advanced Cancer, run by Duke University at 1 site in United States.
Trial summary
This study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Cognitive Behavioral Mutli-Symptom management(CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 8 Sep 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being at least 21 years of age
- a diagnosis of stage IV cancer in the past 3 years
- being able to speak/read English
Who cannot join
- visual or hearing impairment that would prevent ability to engage in the telephone session or study materials
- presence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
This study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment.
Read the detailed description
Individuals with advanced cancers often experience significant symptom burden including pain, fatigue, and psychological distress, all while facing acceptance of the meaning of their advanced disease. Evidence-based behavioral interventions have been developed to alleviate this multiple symptom burden but are understudied and the treatments that are available are often not easily accessed by patients most in need in community-based settings. The current study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment. There is minimal risk related to confidentiality of data and the possibility of feeling uncomfortable in the study. All study contacts will be conducted by trained study staff and supervised by the PI; a licensed clinical psychologist. Participant tracking data will be stored online via REDCAP and accessed only by study staff, participant assessment data will be collected and stored online via REDCap, and audio recordings of study telephone sessions will be stored on Duke servers.
- Conditions
- Advanced Cancer
- Being tested
- Cognitive Behavioral Mutli-Symptom management(CBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Mutli-Symptom management(CBT)Behavioural
Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Mutli-Symptom management(CBT) | Other | Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour. Receives: Behavioral: Cognitive Behavioral Mutli-Symptom management(CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
Feasibility will be shown by no more than 20% study attrition.
Measured: 8 weeks
Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ
Measured: 8 weeks
Feasibility as measured by study accrual by meeting recruitment goal
Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.
Measured: 8 weeks
Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
Measured: 8 weeks
Secondary outcomes (6)
Change in pain
Pain will be assessed with the Brief Pain Inventory (BPI)
Measured: Baseline and 8 weeks
Change in fatigue
Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
Measured: Baseline and 8 weeks
Change in depression
The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
Measured: Baseline and 8 weeks
Change in Mindfulness
Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.
Measured: Baseline and 8 weeks
Change in anxiety
The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
Measured: Baseline and 8 weeks
Change in Acceptance
Acceptance and mindfulness will be assessed using the Acceptance and Action Questionnaire-II, the most widely used measure of mechanism of change in ACT-based medical treatment studies.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start3 Jan 2018
- Primary completion8 Sep 2018
- Study completion8 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Palliative Care Research Cooperative Group
- Responsible party
- Sponsor
- Investigators
- Jennifer Plumb Vilardaga, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285633
- Sponsor's protocol ID
- Pro00080262
- Status last verified
- Aug 2019
- First submitted
- 14 Sep 2017
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Based Mindfulness CBT for Patients in Community Settings With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03285633
- Acronym / sponsor ID
- Pro00080262
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Palliative Care Research Cooperative Group
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 8 Sep 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- 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.
This study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment.
Detailed description
Individuals with advanced cancers often experience significant symptom burden including pain, fatigue, and psychological distress, all while facing acceptance of the meaning of their advanced disease. Evidence-based behavioral interventions have been developed to alleviate this multiple symptom burden but are understudied and the treatments that are available are often not easily accessed by patients most in need in community-based settings. The current study examines the feasibility and acceptability of an open trial of mindfulness-based Cognitive Behavioral Therapy intervention delivered via telephone to men and women age 21 and older with a diagnosis of advanced cancer. Potential participants (N=35) will be recruited via letter from their oncologist at community-based clinics (N=18) and those served at the Duke Cancer Institute in Durham who live more than 60 miles away (N=17). Following informed consent, participants will be asked to complete assessments (e..g., examining their pain, anxiety, depression, fatigue, and engagement in valued activity). They will then receive 4 weekly 50-minute telephone sessions with a study therapist and practice skills learned in session at home. After completing the 4 sessions, they will complete a post-treatment assessment. Data analyses will examine the feasibility and acceptability of the study by assessing participant engagement, and will examine changes in key psychological variables (e.g., pain, anxiety, depression, fatigue, and valued activity) from baseline to post-treatment. There is minimal risk related to confidentiality of data and the possibility of feeling uncomfortable in the study. All study contacts will be conducted by trained study staff and supervised by the PI; a licensed clinical psychologist. Participant tracking data will be stored online via REDCAP and accessed only by study staff, participant assessment data will be collected and stored online via REDCap, and audio recordings of study telephone sessions will be stored on Duke servers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Mutli-Symptom management(CBT) | Other | Behavioral: Cognitive Behavioral Mutli-Symptom management(CBT)Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being at least 21 years of age
- a diagnosis of stage IV cancer in the past 3 years
- being able to speak/read English
Key exclusion criteria (2 listed)
- visual or hearing impairment that would prevent ability to engage in the telephone session or study materials
- presence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff.
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 Mutli-Symptom management(CBT)Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions. | Behavioural | Cognitive Behavioral Mutli-Symptom management(CBT) |
Primary outcome
Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment.
Time frame: 8 weeks
Feasibility will be shown by no more than 20% study attrition.
Acceptability, as measured by Client Satisfaction Questionnaire 10-item version
Time frame: 8 weeks
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the CBT protocol (mean score of 7) on the CSQ
Feasibility as measured by study accrual by meeting recruitment goal
Time frame: 8 weeks
Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.
Feasibility as measured by adherence to the study protocol by number of intervention sessions completed by the participant
Time frame: 8 weeks
Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
6 secondary outcomes
Change in pain
Time frame: Baseline and 8 weeks
Change in fatigue
Time frame: Baseline and 8 weeks
Change in depression
Time frame: Baseline and 8 weeks
Change in Mindfulness
Time frame: Baseline and 8 weeks
Change in anxiety
Time frame: Baseline and 8 weeks
Change in Acceptance
Time frame: Baseline and 8 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 Aug 2019.
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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.
Jennifer Plumb Vilardaga principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Mutli-Symptom management(CBT) in people with Advanced Cancer, run by Duke University at 1 site 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 3 inclusion and 2 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment. (time frame: 8 weeks). The study lists 4 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 Aug 2019.