Innovative Approach to Reduce Lung Cancer Stigma

An Innovative Approach to Reduce Lung Cancer Stigma

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Stigmatization; Stigma, Social; Acceptance Processes; Lung Cancer Stigma
• Intervention / Treatment: Behavioral: ACT-LCS Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: ACT-LCS Therapy; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Heidi Hamann, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2018
• Primary Completion (ACTUAL): July 13, 2020
• Study Completion (ACTUAL): July 13, 2020

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (ACTUAL): November 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Lung cancer; Stigma; Acceptance and commitment therapy; Lung cancer stigma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 29927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No