Innovative Approach to Reduce Lung Canc… | Clinical Trial

Key information

Conditions

Lung Cancer Stigma Acceptance Processes Behavior Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Social Behavior Social Stigma Stereotyping Stigma, Social Stigmatization Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Cancer Center, Tucson, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT-LCS Therapy

Behavioral

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 outcomes

Number of individuals who consent to the intervention

Time frame: 10 months

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

Time frame: 10 months

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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

An Innovative Approach to Reduce Lung Cancer Stigma

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Nov 23, 2018
Registry last updated: Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed