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Recruiting NCT07564960

Social Optimization Study

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Social support receptivity training, Social awareness training.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Feasibility assessed by recruitment and retention rates [Time frame: Throughout the recruitment period]
  • Acceptability assessed by study-specific survey after the intervention [Time frame: 3 weeks - immediately after the intervention]
Secondary outcome measures (6)
  • Change in quality of life (QOL) using the SF-36 from baseline to immediately after the intervention. [Time frame: 3 weeks - immediately after the intervention]
  • Change in Perceived Stress using the Perceived Stress Scale (PSS) from baseline to immediately after the intervention [Time frame: 3 weeks - immediately after the intervention]
  • Change in depression using the CES-D scale from baseline to immediately after the intervention [Time frame: 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 [Time frame: 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 [Time frame: 3 weeks - immediately after the intervention]
  • Change in Multidimensional Scale of Perceived Social Support (MSPSS) scores from baseline to immediately after the intervention [Time frame: 3 weeks - immediately after the intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Arizona Mel and Enid Zuckerman College of Public Health — Tucson

Identifiers

NCT: NCT07564960 · STUDY00007008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗