Innovative Approach to Reduce Lung Cancer Stigma

NCT03750864 | Completed

• 1 other identifier: 29927
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer Stigma; Lung Cancer; Stigma, Social; Stigmatization; Acceptance Processes

Keywords

Lung cancer; Stigma; Lung cancer stigma; Acceptance and commitment therapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

ACT-LCS Therapy

EXPERIMENTAL

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

Interventions

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.

ACT-LCS Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not proficient in English

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (2)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Social Stigma; Stereotyping; Behavior

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Social Behavior

Study Officials

• Heidi Hamann, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Linda Garland, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 23, 2018
• Study Start: October 27, 2018
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)