Social Optimization Study
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (18 Years or Older)
History of lung cancer
at least 12 months since cancer diagnosis
fluent in English
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Social support receptivity training
BehavioralA 3-week, 6-session CBT intervention that targets cognitive awareness of prosocial cues and leverages behavioral activation and social skills training
Social awareness training
BehavioralA 3-week, 6 session program designed to increase awareness of available social support.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Social support receptivity trainingExperimental treatment 1 intervention
Group B: Social awareness trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Throughout the recruitment period2
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.
Time frame
3 weeks - immediately after the interventionSecondary outcomes
1
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).
Time frame
3 weeks - immediately after the intervention2
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.
Time frame
3 weeks - immediately after the intervention3
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.
Time frame
3 weeks - immediately after the intervention4
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.
Time frame
3 weeks - immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov