Social Experiences of Adolescents and Young Adults With Cancer

Participants are being asked to take part in this clinical trial, a type of research study, because investigators want to learn more about the social experiences adolescents and young adults who are being treated or have been treated for cancer.

Primary Objectives

• Describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on treatment status: on versus off therapy.
• In on-therapy patients, describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on developmental stage: high school versus post-high school.

Secondary Objectives

• Assess the social support and peer interaction needs of AYA with cancer as a means of determining stakeholder interest and need for psychosocial interventions targeting social experiences.
• Using qualitative interviews, explore patient perceptions of the impact of cancer on social experiences among AYA, particularly with regards to changes in friendships as a result of the cancer diagnosis and the role of the hospital in helping or hindering friendship maintenance/development.

Exploratory Objectives

• Explore differences in social experience by demographic, disease and treatment factors, including: gender, diagnostic category (brain tumor, leukemia/lymphoma, solid tumor), late effects/symptom burden, and treatment (e.g., treatment intensity, serious medical events).
• Explore associations between perceived impact of cancer and social experience in AYA.
• Explore associations between use of social media and social experience.
• Explore associations between social experiences and overall functioning (quality of life, distress, coping).
• Explore the possibility of subclasses of AYA by using person-centered analyses to empirically derive profiles of social experience.

Study Overview

• Status: Recruiting
• Conditions: Childhood Cancer; Social Behavior; Social Competence

Detailed Description

A mixed-methods design involving questionnaires and interviews will be used to evaluate the study objectives. AYA ages 15 to 22 will be recruited to participate. Two cohorts will be enrolled: AYA who are on-treatment, 2-12 months post-diagnosis; and AYA who are off-therapy 1 to 4 years. AYA will complete questionnaires assessing peer versus family connectedness, peer/romantic competence, coping, distress, social support, and quality of life. A study-specific needs assessment regarding interest in social functioning interventions will also be completed. If a caregiver is available, they will be asked to complete questionnaires regarding family functioning and quality of life. A subset of 50 AYA (30 on-therapy/20 off-therapy) will be interviewed to further explore aspects of peer/family connectedness and intervention interest. Analyses will focus on describing how aspects of social experiences (peer connectedness, social competence, peer versus parent attachment) differ based on treatment status (on versus off therapy) and developmental stage (high school versus post-high school), as well as potential moderators.

Two cohorts of AYA with cancer, ages 15-22, will be identified and recruited for the study: 1) patients on-therapy, 2-12 months from diagnosis; and 2) patients off- therapy 1-4 years, and ≥13 years of age at diagnosis. AYA from all diagnostic groups - brain tumor, solid tumor, leukemia/lymphoma - and developmental periods - high school, post-high school - will be targeted, and care will be taken to ensure a representative sample.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Victoria W. Willard, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Victoria W. Willard, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
      • Principal Investigator: Victoria W. Willard, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

Description

Inclusion Criteria:

• All Participants
• Age 15 - 22
• Primary oncology diagnosis.
• Reads and speaks English.

• On-Therapy Strata

  • 2 - 12 months from diagnosis and receiving cancer-directed therapy.

• Off-Therapy Strata

  • 1 - 4 years post-treatment, diagnosed at ≥13 years of age.
• Caregivers Reads and speaks English
• Consent received from adult participant to contact, as it applies

Exclusion Criteria:

• Surgery only treatment plan.
• IQ less than 70 as documented in the medical record.
• Diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., autism, Neurofibromatosis Type 1 (NF1), Down syndrome).
• Inability or unwillingness of research participant or legal - guardian/representative to give written informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AYA who are on treatment 2-12 months post -diagnosis; AYA will complete questionnaires assessing peer versus family connectedness, peer/romantic competence, coping, distress, social support, and quality of life.A study-specific needs assessment regarding interest in social functioning interventions will also be completed. Participants (30 on-therapy) will be interviewed to further explore aspects of peer/family connectedness and intervention interest.
AYA who are off -therapy 1 to 4 years; AYA will complete questionnaires assessing peer versus family connectedness, peer/romantic competence, coping, distress, social support, and quality of life.A study-specific needs assessment regarding interest in social functioning interventions will also be completed. Participants (20 off-therapy) will be interviewed to further explore aspects of peer/family connectedness and intervention interest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inventory of Parent and Peer Attachment (IPPA).	This is a self-report measure of perceptions of the relationship between an individual and their mother, father and close friends.	Baseline
UCLA Loneliness Scale.	This 20-item self-report questionnaire assesses perceptions of peer connectedness over the past month. Items assess feelings of social connectedness, loneliness, and social isolation. Questions are answered on a 4-point Likert scale from "never" to "often," and a total score is calculated.	Baseline
Family Management Measure (FMM).	This is a 53-item measure for parents designed to assess the impact of a child's health condition on the family system. Six subscales are derived, including measures of the child's daily life, the parent's perceived ability to manage the condition, and, for partnered parents, how the parents work together to manage the condition.	Baseline
Self-Perception Profile for Adolescents/Emerging Adults (SPPA/EA).	The SPPA/EA is a self-report measure of self-competence. Multiple constructs are assessed, including social, romantic, physical, and academic competence, as well as global self-worth. Subscales assessing Social Competence, Romantic Competence and Physical Appearance are of primary interest.	Baseline
NIH Toolbox - Friendship	This is a 5- (ages 15-17) or 8-item (ages 18+) self- report questionnaire that assesses aspects of friendship. Questions assess perceived ability to access friend and participation in activities with friends over the past month on a 5-point Likert scale from never to always. Five items are similar across the two age groups. Raw scores are converted to T-scores (M = 50, SD = 10), with higher scores indicative of more perceived friends to interact with.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Young Adult Cancer Impact Scale	This is a 5-item self-report measure that assesses an individual's perception of the impact of cancer on relevant domains: education, social interaction, career goals, romantic relationships and independent living. Items are rated on a 1-10 scale from "did not interfere/affect" to "extremely interfered/affected." The social interaction and romantic relationship items are of primary interest.	Baseline
Centrality of Events (COE).	The COE is a 20-item self-report measure that assesses an individual's perception of the impact that a traumatic or significant event as had on their identity development. Participants will be asked to complete the COE based on their experiences with cancer.	Baseline
Online Social Support Scale (OSSS).	The two part OSSS assesses the role of online apps or websites in an individual's perception of the support they receive from others. In the first part, participants rate the frequency that they use specific online spaces (e.g., Instagram, Twitter, Facebook) to interact with others. Space is also provided for participants to free text additional sites. In the second part, 40 items assess the types of social support individuals receive from these spaces, with four subscales derived: Esteem/Emotional Support, Social Companionship, Informational Support, and Instrumental Support. Oneline Social Support Scale-scores could range from 0 to 160 with higher scores indicating receipt of more support.	Baseline
Multidimensional Scale of Perceived Social Support (MSPSS).	The MSPSS is a 12-item self-report questionnaire that assesses perceived reception of support from important persons - friends, family, and significant other. Questions are answered on 7-item Likert scale from "very strong disagree" to "very strongly agree." Higher scores are indicative of more social support.	Baseline
Responses to Stress Questionnaire (RSQ)	The RSQ is a 57-item self-report questionnaire assessing an individual's coping with an identified stressor. For this study, cancer will be the identified stressor and separate versions of the RSQ are available for those on treatment and off treatment. Responses to Stress Questionnaire - scores range from 0 to 4 with higher scores indicating more use of that coping mechanism	Baseline
PROMIS Profile / Pediatric Profile	Three brief self-report measures will assess symptoms of anxiety, depression, and fatigue over the past 7 days. Measures will be completed by both AYA and their caregivers, with each respondent providing indicators of their own level of distress. Raw scores are converted to T- scores (M = 50, SD = 10) with higher scores indicating greater symptoms.	Baseline
PedsQL - Cancer Specific Module	The PedsQL Cancer Module is a 27-item self-report measure that assesses symptom burden and quality of life as related to cancer-specific factors, including pain, nausea, procedural anxiety, and physical appearance. AYA will complete this measure as an indicator of current cancer- related symptoms. PedsQL - scores range 0 to 100 with higher scores indicating better functioning	Baseline
PedsQL - Core Module	The PedsQL Core Module is a 23-item measure of quality of life, with both self- and proxy-report versions available. Four subscales provide two broad domains - Physical and Psychosocial Functioning - and an overall quality of life score. Raw scores undergo a linear transformation. AYA and their participating caregiver will complete this measure.	Baseline
Intensity of Treatment (ITR-3).	The ITR-3 is a clinician-completed rating form that provides a means of classifying the intensity of pediatric cancer treatment. Four categories are elicited: Least, Moderately, Very, and Most Intensive. This will be completed for each participant using information gathered from the medical record.	Baseline
Needs Assessment	This is a new questionnaire developed specifically for this study. Participants will answer questions about their participation in current hospital activities and events as well as their interest in and feedback on future interventions. It will be analyzed at the individual item level.	Baseline
Qualitative Interview	A subsample of participants will complete an interview to further assess aspects of friendships and intervention interest. Participant responses will be transcribed and analyzed for themes.	Baseline

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Victoria W. Willard, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CONNECT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No