NCT07564960

Brief Summary

This study tests whether clinical interventions to optimize support receptivity lead to improvements in social integration and quality of life (QOL) amongst long-term lung cancer survivors. The feasibility and acceptability of the intervention and assessment procedures will be examined. Thirty long-term lung cancer survivors will be randomized to a support receptivity intervention or an attention-control condition. Our intervention draws on cognitive behavioral therapy (CBT) strategies to reduce social anxiety, improve social awareness, and promote social integration. We will use two novel in vivo sampling methods using a mobile phone platform to assess social engagement and QOL improvements: 1) recording via the Electronically Activated Recorder to capture daily social interactions, and 2) repeated self-report sampling where participants answer questions about their social engagement experiences via their personal cell phone.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2026

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Social supportPsycho-oncologyLung neoplasms

Outcome Measures

Primary Outcomes (2)

  • Feasibility assessed by recruitment and retention rates

    Given the pilot nature of this work, the intervention/study will be deemed feasible if 20% of eligible potential participants approached enroll and 50% of enrolled participants are retained at post-intervention

    Throughout the recruitment period

  • Acceptability assessed by study-specific survey after the intervention

    The intervention/study will be deemed acceptable if, on average, participants report satisfaction with the overall program/study as ≥2 on a 0-4 scale.

    3 weeks - immediately after the intervention

Secondary Outcomes (6)

  • Change in quality of life (QOL) using the SF-36 from baseline to immediately after the intervention.

    3 weeks - immediately after the intervention

  • Change in Perceived Stress using the Perceived Stress Scale (PSS) from baseline to immediately after the intervention

    3 weeks - immediately after the intervention

  • Change in depression using the CES-D scale from baseline to immediately after the intervention

    3 weeks - immediately after the intervention

  • Change in network diversity using the Berkman-Syme Social Network Index (BS-SNI) from baseline to immediately after the intervention

    3 weeks - immediately after the intervention

  • Change in subject loneliness and social isolation using the UCLA-Loneliness Scale from baseline to immediately after the intervention

    3 weeks - immediately after the intervention

  • +1 more secondary outcomes

Study Arms (2)

Social support receptivity training

EXPERIMENTAL

Participants will receive a 3-week, 6 session CBT intervention targeting cognitive awareness of prosocial cues coupled with behavioral activation and social skills training to improve target person social engagement.

Behavioral: Social support receptivity training

Social awareness training

ACTIVE COMPARATOR

Participants receiving a 3-week, 6 session program designed to increase awareness of the social support already available to them.

Behavioral: Social awareness training

Interventions

A 3-week, 6-session CBT intervention that targets cognitive awareness of prosocial cues and leverages behavioral activation and social skills training

Social support receptivity training

A 3-week, 6 session program designed to increase awareness of available social support.

Social awareness training

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18 Years or Older)
  • History of lung cancer
  • at least 12 months since cancer diagnosis
  • fluent in English
  • able to attend virtually or in person sessions at the University of Arizona.

You may not qualify if:

  • Less than 12 months of cancer diagnosis at time of enrollment
  • undergoing treatment for mood or anxiety health issues at time of enrollment
  • unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Mel and Enid Zuckerman College of Public Health

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Scott Carvajal, PhD, MPH

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis Morales-Lozada

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

April 29, 2026

Primary Completion (Estimated)

June 13, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations