Childhood CancerNCT04328350
Social Experiences of Adolescents and Young Adults With Cancer
An observational study of Childhood Cancer and Social Behavior, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Childhood Cancer, Social Behavior, Social Competence
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
Read more
- 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.
Read the 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.
- Conditions
- Childhood Cancer, Social Behavior, Social Competence
- Medical subject headings
- Neoplasms, Social Behavior, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start12 Oct 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah W. Daniels, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328350
- Sponsor's protocol ID
- CONNECT
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2020
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Experiences of Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT04328350
- Acronym / sponsor ID
- CONNECT
- Conditions
- Childhood Cancer, Social Behavior, Social Competence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (10 listed)
- All Participants
- Age 15 - 22
- Primary oncology diagnosis.
- Reads and speaks English.
- On-Therapy Strata
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inventory of Parent and Peer Attachment (IPPA).
Time frame: Baseline
This is a self-report measure of perceptions of the relationship between an individual and their mother, father and close friends.
UCLA Loneliness Scale.
Time frame: Baseline
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.
Family Management Measure (FMM).
Time frame: Baseline
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.
Self-Perception Profile for Adolescents/Emerging Adults (SPPA/EA).
Time frame: Baseline
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.
NIH Toolbox - Friendship
Time frame: Baseline
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.
11 secondary outcomes
Young Adult Cancer Impact Scale
Time frame: Baseline
Centrality of Events (COE).
Time frame: Baseline
Online Social Support Scale (OSSS).
Time frame: Baseline
Multidimensional Scale of Perceived Social Support (MSPSS).
Time frame: Baseline
Responses to Stress Questionnaire (RSQ)
Time frame: Baseline
PROMIS Profile / Pediatric Profile
Time frame: Baseline
PedsQL - Cancer Specific Module
Time frame: Baseline
PedsQL - Core Module
Time frame: Baseline
Intensity of Treatment (ITR-3).
Time frame: Baseline
Needs Assessment
Time frame: Baseline
Qualitative Interview
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah W. Daniels, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Social Behavior, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Parent and Peer Attachment (IPPA). (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.