Anatomic Stage I Breast Cancer AJCC v8NCT07259304
Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of Southern California at 3 sites in United States.
Trial summary
This longitudinal observational study examines how social health, including social support, social roles, loneliness, social anxiety, and social network characteristics, relates to physical activity, sedentary time, and quality of life among ethnically and racially diverse adolescent and young adult (AYA) cancer… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Medical Device Usage and Evaluation, Quality-of-Life Assessment and Survey Administration
- How many people
- 173 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Nov 2021to 31 Dec 2027
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed and/or treated with cancer between ages 18-39 at University of Southern California (USC) hospitals.
Who may be able to join
- Age 18-39 years at cancer diagnosis.
- Newly diagnosed (within past 3 months) with one of the following cancer types commonly seen in AYAs: testis, breast, thyroid, cervix, colorectal, brain/central nervous system, non Hodgkin lymphoma, uterine, melanoma, bones and joints, ovary, Hodgkin lymphoma, lung, or gastric cancer.
- Stage I-IV for solid tumors (AJCC 8th edition TNM staging) or I-IV for lymphomas (Ann Arbor staging).
- Receiving care at a participating USC affiliated hospital (USC Norris Comprehensive Cancer Center, Keck Hospital of USC, or Los Angeles General Medical Center) or MD Anderson Cancer Center.
- Clinician assessed expected survival greater than 12 months at time of diagnosis.
- Able to complete questionnaires and wear a wrist worn accelerometer.
- English or Spanish speaking.
Who cannot join
- Leukemia (excluded due to longer treatment duration and different care trajectory).
- Primary language other than English or Spanish.
- Cognitive or physical limitations that preclude completion of surveys or wearing an accelerometer.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Los Angeles General Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors: A Longitudinal Study
This longitudinal observational study examines how social health, including social support, social roles, loneliness, social anxiety, and social network characteristics, relates to physical activity, sedentary time, and quality of life among ethnically and racially diverse adolescent and young adult (AYA) cancer patients aged 18-39 years. The study follows participants over four clinically significant timepoints in the first 12 months after diagnosis (baseline near diagnosis, mid treatment, near end of treatment, and 12 month follow up). At each timepoint, patients complete questionnaires and wear a wrist worn accelerometer for one week.
Read the detailed description
PRIMARY OBJECTIVES:
- Characterize trajectories of social health over the course of cancer treatment and into early survivorship; II. Investigate longitudinal and potentially reciprocal associations between social health and activity behaviors (physical activity and sedentary time) and their relationship to quality of life; III. Examine whether gender, race/ethnicity, socioeconomic status, and symptom burden moderate these associations.
OUTLINE:
Patients complete surveys over 40 minutes and wear an actigraph GT3X-BT accelerometer continuously for 7 days at baseline, 3, 6, and 12 months.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Medical Device Usage and Evaluation, Quality-of-Life Assessment, Survey Administration
- Medical subject headings
- Central Nervous System Neoplasms, Hodgkin Disease, Bone Neoplasms, Brain Neoplasms, Testicular Neoplasms, Lymphoma, Non-Hodgkin, Uterine Cervical Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Usage and EvaluationOther
Wear an actigraph GT3X-BT accelerometer
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete survey
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (actigraph, surveys) | Patients complete surveys and wear an actigraph GT3X-BT accelerometer continuously for 7 days at baseline, 3, 6, and 12 months. Receives: Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in social role functioning
Assessed using the PROMIS Ability to Participate in Social Roles and Activities Short Form 4a, which measures limitations in participation in usual social roles and activities due to health (higher scores indicate better participation).
Measured: Baseline up to 1 year
Change in perceived emotional support
Assessed using the PROMIS Emotional Support Short Form 4a, which measures perceived availability of people who provide emotional support, such as care, understanding, and someone to listen (higher scores indicate more emotional support).
Measured: Baseline up to 1 year
Change in perceived informational support
Assessed using the PROMIS Informational Support Short Form 4a, which measures perceived availability of people who provide advice, information, and guidance (higher scores indicate more informational support).
Measured: Baseline up to 1 year
Change in perceived instrumental support
Assessed using the PROMIS Instrumental Support Short Form 4a, which measures perceived availability of people who provide practical help and assistance with tasks (higher scores indicate more instrumental support).
Measured: Baseline up to 1 year
Change in loneliness score
Assessed using the UCLA Loneliness Scale short form, which measures subjective feelings of loneliness and social disconnection (higher scores indicate greater loneliness).
Measured: Baseline up to 1 year
Change in social anxiety symptoms
Assessed using the Mini Social Phobia Inventory (Mini SPIN), a brief validated measure of social anxiety and fear of social interactions (higher scores indicate greater social anxiety).
Measured: Baseline up to 1 year
Change in social network density
Assessed using a study developed egocentric social network questionnaire in which participants list up to 10 important adult social contacts and indicate which contacts know each other; density is calculated as the proportion of possible ties that are present (higher values indicate a more densely connected network).
Measured: Baseline up to 1 year
Change in proportion of supportive social ties
Assessed using a study developed egocentric social network questionnaire that measures whether each named social contact provides social support and encouragement for physical activity; the outcome is the proportion of social ties providing support (higher values indicate a more supportive network).
Measured: Baseline up to 1 year
Change in frequency of social contact
Assessed using a study developed egocentric social network questionnaire that captures how often participants interact with each named social contact; the outcome is the average reported frequency of contact across alters (higher values indicate more frequent social contact).
Measured: Baseline up to 1 year
Change in total daily physical activity
Assessed using a wrist worn ActiGraph GT3X BT accelerometer worn for 7 consecutive days at each time point. Raw data are converted to monitor independent movement summary (MIMS) units, and total daily physical activity is represented by average daily MIMS units across valid wear days (higher values indicate more physical activity).
Measured: Baseline up to 1 year
Change in total daily sedentary time
Assessed using a wrist worn ActiGraph GT3X BT accelerometer worn for 7 consecutive days at each time point. Sedentary time is calculated from accelerometer data as average minutes per day spent in sedentary behavior (e.g., low movement periods while awake) across valid wear days (higher values indicate more sedentary time).
Measured: Baseline up to 1 year
Secondary outcomes (2)
Change in Quality of Life
Patient reported quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10, assessed at baseline and 12 month follow up. This is a 10-item patient-reported questionnaire measuring general physical, mental, and social health. Most questions use a 1-to-5 point scale. Higher numerical values consistently represent better health or lower symptoms. The survey produces two separate scores: Global Physical Health (GPH) and Global Mental Health (GMH). Raw response values are summed and converted into standardized T-scores where a score of 50 represents the U.S. general population average (standard deviation of 10).
Measured: Baseline up to 1 year
Symptom Burden
Symptom burden assessed using the MD Anderson Symptom Inventory (MDASI) at all four timepoints. This survey is a multi-symptom patient-reported outcome (PRO) measure used to assess the severity of symptoms experienced by patients with cancer and the interference with daily living caused by these symptoms.
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start24 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberly Miller, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259304
- Sponsor's protocol ID
- 0S-20-10
- Other IDs
- NCI-2021-05723, 0S-20-10, P30CA014089, R37CA256867
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT07259304
- Acronym / sponsor ID
- 0S-20-10
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2025 (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.
This longitudinal observational study examines how social health, including social support, social roles, loneliness, social anxiety, and social network characteristics, relates to physical activity, sedentary time, and quality of life among ethnically and racially diverse adolescent and young adult (AYA) cancer patients aged 18-39 years. The study follows participants over four clinically significant timepoints in the first 12 months after diagnosis (baseline near diagnosis, mid treatment, near end of treatment, and 12 month follow up). At each timepoint, patients complete questionnaires and wear a wrist worn accelerometer for one week.
Detailed description
PRIMARY OBJECTIVES:
- Characterize trajectories of social health over the course of cancer treatment and into early survivorship; II. Investigate longitudinal and potentially reciprocal associations between social health and activity behaviors (physical activity and sedentary time) and their relationship to quality of life; III. Examine whether gender, race/ethnicity, socioeconomic status, and symptom burden moderate these associations.
OUTLINE:
Patients complete surveys over 40 minutes and wear an actigraph GT3X-BT accelerometer continuously for 7 days at baseline, 3, 6, and 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (actigraph, surveys) | – | Other: Medical Device Usage and Evaluation, Other: Quality-of-Life Assessment, Other: Survey AdministrationPatients complete surveys and wear an actigraph GT3X-BT accelerometer continuously for 7 days at baseline, 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed and/or treated with cancer between ages 18-39 at University of Southern California (USC) hospitals.
Key inclusion criteria (7 listed)
- Age 18-39 years at cancer diagnosis.
- Newly diagnosed (within past 3 months) with one of the following cancer types commonly seen in AYAs: testis, breast, thyroid, cervix, colorectal, brain/central nervous system, non Hodgkin lymphoma, uterine, melanoma, bones and joints, ovary, Hodgkin lymphoma, lung, or gastric cancer.
- Stage I-IV for solid tumors (AJCC 8th edition TNM staging) or I-IV for lymphomas (Ann Arbor staging).
- Receiving care at a participating USC affiliated hospital (USC Norris Comprehensive Cancer Center, Keck Hospital of USC, or Los Angeles General Medical Center) or MD Anderson Cancer Center.
- Clinician assessed expected survival greater than 12 months at time of diagnosis.
Key exclusion criteria (3 listed)
- Leukemia (excluded due to longer treatment duration and different care trajectory).
- Primary language other than English or Spanish.
- Cognitive or physical limitations that preclude completion of surveys or wearing an accelerometer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Usage and EvaluationWear an actigraph GT3X-BT accelerometer | Other | Observational (actigraph, surveys) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete survey | Other | Observational (actigraph, surveys) |
| Survey AdministrationComplete survey | Other | Observational (actigraph, surveys) |
Primary outcome
Change in social role functioning
Time frame: Baseline up to 1 year
Assessed using the PROMIS Ability to Participate in Social Roles and Activities Short Form 4a, which measures limitations in participation in usual social roles and activities due to health (higher scores indicate better participation).
Change in perceived emotional support
Time frame: Baseline up to 1 year
Assessed using the PROMIS Emotional Support Short Form 4a, which measures perceived availability of people who provide emotional support, such as care, understanding, and someone to listen (higher scores indicate more emotional support).
Change in perceived informational support
Time frame: Baseline up to 1 year
Assessed using the PROMIS Informational Support Short Form 4a, which measures perceived availability of people who provide advice, information, and guidance (higher scores indicate more informational support).
Change in perceived instrumental support
Time frame: Baseline up to 1 year
Assessed using the PROMIS Instrumental Support Short Form 4a, which measures perceived availability of people who provide practical help and assistance with tasks (higher scores indicate more instrumental support).
Change in loneliness score
Time frame: Baseline up to 1 year
Assessed using the UCLA Loneliness Scale short form, which measures subjective feelings of loneliness and social disconnection (higher scores indicate greater loneliness).
Change in social anxiety symptoms
Time frame: Baseline up to 1 year
Assessed using the Mini Social Phobia Inventory (Mini SPIN), a brief validated measure of social anxiety and fear of social interactions (higher scores indicate greater social anxiety).
Change in social network density
Time frame: Baseline up to 1 year
Assessed using a study developed egocentric social network questionnaire in which participants list up to 10 important adult social contacts and indicate which contacts know each other; density is calculated as the proportion of possible ties that are present (higher values indicate a more densely connected network).
Change in proportion of supportive social ties
Time frame: Baseline up to 1 year
Assessed using a study developed egocentric social network questionnaire that measures whether each named social contact provides social support and encouragement for physical activity; the outcome is the proportion of social ties providing support (higher values indicate a more supportive network).
Change in frequency of social contact
Time frame: Baseline up to 1 year
Assessed using a study developed egocentric social network questionnaire that captures how often participants interact with each named social contact; the outcome is the average reported frequency of contact across alters (higher values indicate more frequent social contact).
Change in total daily physical activity
Time frame: Baseline up to 1 year
Assessed using a wrist worn ActiGraph GT3X BT accelerometer worn for 7 consecutive days at each time point. Raw data are converted to monitor independent movement summary (MIMS) units, and total daily physical activity is represented by average daily MIMS units across valid wear days (higher values indicate more physical activity).
Change in total daily sedentary time
Time frame: Baseline up to 1 year
Assessed using a wrist worn ActiGraph GT3X BT accelerometer worn for 7 consecutive days at each time point. Sedentary time is calculated from accelerometer data as average minutes per day spent in sedentary behavior (e.g., low movement periods while awake) across valid wear days (higher values indicate more sedentary time).
2 secondary outcomes
Change in Quality of Life
Time frame: Baseline up to 1 year
Symptom Burden
Time frame: Baseline up to 1 year
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 5 Oct 2026.
Related trials for Anatomic Stage I Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
RecruitingPhase 2
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Recruiting
Researching the Effect of Exercise on Cancer
Breast Cancer, Prostate Cancer
RecruitingPhase 1/2
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
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.
Kimberly Miller, PhD principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of Southern California at 3 sites 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 7 inclusion and 3 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change in social role functioning (time frame: Baseline up to 1 year). The study lists 11 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 5 Oct 2026.