Advanced Cancer
Conditions
Brief 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. 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.
Interventions
BEHAVIORALCognitive Behavioral Mutli-Symptom management(CBT)
Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
Sponsors
Palliative Care Research Cooperative Group
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* being at least 21 years of age * a diagnosis of stage IV cancer in the past 3 years * being able to speak/read English
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by study attrition which will be assessed by patients who do not complete the post-assessment. | 8 weeks | Feasibility will be shown by no more than 20% study attrition. |
| Acceptability, as measured by Client Satisfaction Questionnaire 10-item version | 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 | 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 | 8 weeks | Feasibility will be shown by adherence to at least 75% of the intervention sessions (3/4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety | Baseline and 8 weeks | The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms) |
| Change in pain | Baseline and 8 weeks | Pain will be assessed with the Brief Pain Inventory (BPI) |
| Change in Acceptance | 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. |
| Change in fatigue | Baseline and 8 weeks | Fatigue will be assessed with the PROMIS Adult Fatigue Profile Short Form. |
| Change in depression | Baseline and 8 weeks | The Hospital Anxiety and Depression Scale will be used to assess distress (anxiety and depressive symptoms) |
| Change in Mindfulness | 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. |
Countries
United States
Outcome results
None listed