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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03750864
Other study ID # 29927
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 27, 2018
Est. completion date July 13, 2020

Study information

Verified date July 2022
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a feasibility study examining the feasibility and acceptability of a novel psychotherapy intervention on lung cancer patients who are experiencing stigma.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 13, 2020
Est. primary completion date July 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
ACT-LCS Therapy
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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Arizona Cancer Center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 months
Primary 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. 10 months
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