Innovative Approach to Reduce Lung Cancer Stigma

Lung Cancer Clinical Trial

Official title:

An Innovative Approach to Reduce Lung Cancer Stigma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750864
• Other study ID #: 29927
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acceptance Processes
• Lung Cancer
• Lung Cancer Stigma
• Lung Neoplasms
• Stigma, Social
• Stigmatization

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