Innovative Approach to Reduce Lung Cancer Stigma
Primary Purpose
Lung Cancer Stigma, Lung Cancer, Stigma, Social
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT-LCS Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer Stigma focused on measuring Lung cancer, Stigma, Lung cancer stigma, Acceptance and commitment therapy
Eligibility Criteria
Inclusion Criteria:
- Proficiency in English
- Diagnosed with or treated for Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) within the prior 12 months.
- Scores of 37.5 on the Lung Cancer Stigma Inventory (LCSI) screening measure
Exclusion Criteria:
- Not proficient in English
Sites / Locations
- University of Arizona Cancer Center
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACT-LCS Therapy
Arm Description
Intervention is psychosocial counseling utilizing Acceptance and Commitment Therapy for Lung Cancer Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma.
Outcomes
Primary Outcome Measures
Number of individuals who consent to the intervention
This measure will be calculated as a function of those eligible and approached who consented to the intervention. It will be utilized as a metric of feasibility and acceptability.
Number of sessions that each consented patient attended
This measure will be calculated as a count of sessions that each consented participant attended. It will be utilized as a metric of acceptability of the intervention among consented participants.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03750864
Brief Title
Innovative Approach to Reduce Lung Cancer Stigma
Official Title
An Innovative Approach to Reduce Lung Cancer Stigma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2018 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
July 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a feasibility study examining the feasibility and acceptability of a novel psychotherapy intervention on lung cancer patients who are experiencing stigma.
Detailed Description
Experiences of stigma (perception and internalization of negative appraisal and devaluation from others) are pervasive for lung cancer patients. Previous work has shown associations between lung cancer stigma and detriments in clinically relevant outcomes such as depression, lower quality of life, and reduced engagement in cancer care.
The investigators previously developed Acceptance and Commitment Therapy for Lung Cancer Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma. ACT-LCS is based in Acceptance and Commitment Therapy (ACT), a cognitive-behavioral treatment that promotes psychological flexibility through acceptance and valued direction.
This is a feasibility study examining the feasibility and acceptability of ACT-LCS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Stigma, Lung Cancer, Stigma, Social, Stigmatization, Acceptance Processes
Keywords
Lung cancer, Stigma, Lung cancer stigma, Acceptance and commitment therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACT-LCS Therapy
Arm Type
Experimental
Arm Description
Intervention is psychosocial counseling utilizing Acceptance and Commitment Therapy for Lung Cancer Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma.
Intervention Type
Behavioral
Intervention Name(s)
ACT-LCS Therapy
Intervention Description
All participants in Stage 1, and those randomized to the intervention condition in Stage 2, will receive the Acceptance & Commitment Therapy for Lung Cancer Stigma (ACT-LCS) intervention. The ACT-LC intervention is designed to be delivered as 6 sessions of individual psychotherapy with a trained psychotherapist at a weekly or bimonthly rate, delivered either in person or over the phone. The treatment manual is based in Acceptance and Commitment Therapy (ACT). Therapists are instructed to begin treatment with Module 1. Modules 2-5 can then be administered in any order at the discretion of the therapist, based upon what the therapist thinks is most likely to be helpful to the patient. Module 6 is the final session of treatment.
Primary Outcome Measure Information:
Title
Number of individuals who consent to the intervention
Description
This measure will be calculated as a function of those eligible and approached who consented to the intervention. It will be utilized as a metric of feasibility and acceptability.
Time Frame
10 months
Title
Number of sessions that each consented patient attended
Description
This measure will be calculated as a count of sessions that each consented participant attended. It will be utilized as a metric of acceptability of the intervention among consented participants.
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Proficiency in English
Diagnosed with or treated for Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) within the prior 12 months.
Scores of 37.5 on the Lung Cancer Stigma Inventory (LCSI) screening measure
Exclusion Criteria:
Not proficient in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Hamann, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Garland, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Innovative Approach to Reduce Lung Cancer Stigma
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