Social Optimization Study

Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Social support receptivity training; Behavioral: Social awareness training

Detailed Description

The growing cancer survivorship population. This year, more than 1.77 million Americans will receive a life-altering cancer diagnosis. Fortunately, improvements in early detection and care have led to dramatic increases in survival. Over 18 million Americans or 5.4% of the total U.S. population now identify as cancer survivors with an expected growth to 26 million by 2040. Recognition of these immense changes in survival has led the National Cancer Institute (NCI) to found the Office of Cancer Survivorship (OCS) with a stated goal of "enhancing the quality and length of survival of all persons diagnosed with cancer…" Consistent with its mission, NCI/OCS is prioritizing research that improves the QOL of this growing survivorship population.

Social integration is a critical moderator. Social integration is one potential resilience factor that may be key to improving QOL among cancer survivors. Social integration, the degree of social embeddedness and strength of social ties, is amongst the most robust predictors of a broad range of mental and physical health outcomes. Robust, replicated research documents that people who are more socially integrated experience lower rates of depression, anxiety, and most forms of chronic illness and experience lower age-adjusted disease-specific and all-cause mortality. Decades of research show that interventions to provide more support including via support groups, community events, or provision of supportive persons can improve mental and physical health outcomes. At the same time, the improvements in these outcomes are modest, suggesting that not all relevant factors are accounted for.

Work from our team examining Hispanic advantages in mental and physical health via culturally moderated social integration suggest that support receptivity is a key element of social integration effectiveness. This revelation suggests that social integration is an interactive process not unlike effective neuronal communication. Neuron communication is moderated by both the adequacy of the signal and the sensitivity of the receptor. Both must be effective for transmission to take place. Social integration benefits may work the same way. While nearly all social integration interventions have focused on providing sufficient support, almost no interventions have sought to enhance support receptivity to enhance social integration effects in the context of physical health such as cancer survivorship.

The current goal is to test whether clinical interventions to optimize support receptivity lead to improvements in social integration and QOL amongst cancer survivor populations. A pilot randomized clinical trial is proposed to evaluate feasibility and acceptability of the intervention and assessment procedures, and to explore whether the intervention can improve QOL through optimizing survivors' social receptivity to determine proof-of-concept. We propose to enroll 30 long-term (> 12 months post-treatment) lung cancer survivors randomized to either a support receptivity intervention or attention-control condition. Our intervention draws on the large body of cognitive behavioral therapy (CBT) interventions to reduce social anxiety, improve social awareness, and promote social integration for a wide range of mental health conditions. The proposed 3-week, 6 session CBT intervention specifically targets cognitive awareness of prosocial cues coupled with Behavioral Activation and Social Skills Training to improve target person social engagement. Building on our ongoing, NCI-funded work on social engagement in lung cancer patients, 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 (EAR)17 to capture frequency of daily social interactions, and 2) repeated self-report sampling (ecological momentary assessments) where participants will be prompted to answer questions about their social engagement experiences via their personal cell phone.

The following aims are proposed:

Aim 1: Explore whether a CBT intervention targeting social receptivity can improve QOL in cancer survivors compared to an attention control condition to determine proof-of-concept. Hypothesis: We expect that the intervention will produce improvements via the targeted mechanism with sustained differences at 2 months post.

Aim 2: Explore the degree to which the CBT intervention increases objectively assessed social engagement as a putative mechanism. Hypothesis: We expect to demonstrate proof-of-concept that social engagement is malleable with implications for survivor mental and social health in alignment with NCI survivorship priorities.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis Morales-Lozada; Phone Number: (520) 621-0563; Email: fmoraleslozada@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona Mel and Enid Zuckerman College of Public Health
      • Contact: Francis Morales-Lozada; Phone Number: (520) 621-0563; Email: fmoraleslozada@arizona.edu
      • Principal Investigator: Scott Carvajal, PhD, MPH
      • Sub-Investigator: John Ruiz, PhD
      • Sub-Investigator: Matthias Mel, PhD
      • Sub-Investigator: Linda Garland, MD
      • Sub-Investigator: Rina Fox, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social support receptivity training; 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; A 3-week, 6-session CBT intervention that targets cognitive awareness of prosocial cues and leverages behavioral activation and social skills training
Active Comparator: Social awareness training; Participants receiving a 3-week, 6 session program designed to increase awareness of the social support already available to them.	Behavioral: Social awareness training; A 3-week, 6 session program designed to increase awareness of available social support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life (QOL) using the SF-36 from baseline to immediately after the intervention.	Participants will complete the 36-item SF-36, which evaluates eight health domains-physical functioning, pain, vitality, social functioning, and mental health-covering physical and mental components. Scores on each domain range from 0-100, with higher scores indicating better quality of life (QOL).	3 weeks - immediately after the intervention
Change in Perceived Stress using the Perceived Stress Scale (PSS) from baseline to immediately after the intervention	Participants will complete a 10-item PSS, which evaluates an individual's stress level. Scores range from 0-40, with higher scores indicating higher perceived stress.	3 weeks - immediately after the intervention
Change in depression using the CES-D scale from baseline to immediately after the intervention	Participants will complete a 10-item CES-D, which evaluates an individual's self-reported symptoms of depression. The total score is calculated by totaling all items scored after reversing the positive mood items. Possible range for scores is 0-11 with higher scores representing greater degrees of depressed mood.	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	Participants will complete the BS-SNI, which assesses network diversity, and the number of people in an individual's network.	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	Participants will complete the 10-item UCLA Loneliness Scale, which measures subjective loneliness and social isolation. Higher scores represent higher levels of loneliness.	3 weeks - immediately after the intervention
Change in Multidimensional Scale of Perceived Social Support (MSPSS) scores from baseline to immediately after the intervention	Participants will complete a 12-item MSPSS, which measures an individual's perception of support. A sum through all scores can range from 12-84, with higher scores noting a higher perceived support.	3 weeks - immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Scott Carvajal, PhD, MPH, University of Arizona

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2026
• Primary Completion (Estimated): June 13, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lung neoplasms; Social support; Psycho-oncology
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: STUDY00007008

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