Duke University Medical Center
Durham, North Carolina, 27705, United States
NCT Number: NCT03285633
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.
Looking for future studies?
Notify Me21 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
Time frame: 8 weeks
Feasibility will be shown by no more than 20% study attrition.
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
Time frame: 8 weeks
Feasibility will be shown by meeting targeted study accrual (N=35) in the 12-month study period.
Time frame: 8 weeks
Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4)
Time frame: Baseline and 8 weeks
Pain will be assessed with the Brief Pain Inventory (BPI)
Time frame: Baseline and 8 weeks
Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form.
Time frame: Baseline and 8 weeks
The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
Time frame: Baseline and 8 weeks
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.
Time frame: Baseline and 8 weeks
The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms)
Time frame: Baseline and 8 weeks
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.
Duke University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04864418
Advanced Cancer
Seoul, South Korea
View Trial DetailsNCT07712237
Advanced Cancer
Taipei, Taipei City, Taiwan
View Trial DetailsNCT06722014
Advanced Cancer, Mental Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT05375994
Advanced Cancer, Bronchial Neoplasms
San Francisco, California, United States
View Trial Details