NCT07259304

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Nov 2021Dec 2027

First Submitted

Initial submission to the registry

October 14, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
4 years until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

5.1 years

First QC Date

October 14, 2021

Last Update Submit

July 29, 2026

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Central Nervous System NeoplasmClinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8Clinical Stage IIB Cutaneous Melanoma AJCC v8Clinical Stage IIC Cutaneous Melanoma AJCC v8Clinical Stage III Cutaneous Melanoma AJCC v8Hodgkin LymphomaMalignant Bone NeoplasmMalignant Brain NeoplasmMalignant Solid NeoplasmMalignant Testicular NeoplasmNon-Hodgkin LymphomaPathologic Stage I Cutaneous Melanoma AJCC v8Pathologic Stage IA Cutaneous Melanoma AJCC v8Pathologic Stage IB Cutaneous Melanoma AJCC v8Pathologic Stage IIA Cutaneous Melanoma AJCC v8Pathologic Stage IIB Cutaneous Melanoma AJCC v8Pathologic Stage IIC Cutaneous Melanoma AJCC v8Pathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Stage I Cervical Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Differentiated Thyroid Gland Carcinoma AJCC v8Stage I Ovarian Cancer AJCC v8Stage I Thyroid Gland Medullary Carcinoma AJCC v8Stage I Uterine Corpus Cancer AJCC v8Stage IA Cervical Cancer AJCC v8Stage IA Ovarian Cancer AJCC v8Stage IA Uterine Corpus Cancer AJCC v8Stage IA1 Cervical Cancer AJCC v8Stage IA2 Cervical Cancer AJCC v8Stage IB Cervical Cancer AJCC v8Stage IB Ovarian Cancer AJCC v8Stage IB Uterine Corpus Cancer AJCC v8Stage IB1 Cervical Cancer AJCC v8Stage IB2 Cervical Cancer AJCC v8Stage IC Ovarian Cancer AJCC v8Stage II Cervical Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Ovarian Cancer AJCC v8Stage II Thyroid Gland Medullary Carcinoma AJCC v8Stage II Uterine Corpus Cancer AJCC v8Stage IIA Cervical Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIA Ovarian Cancer AJCC v8Stage IIA1 Cervical Cancer AJCC v8Stage IIA2 Cervical Cancer AJCC v8Stage IIB Cervical Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage III Differentiated Thyroid Gland Carcinoma AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Thyroid Gland Medullary Carcinoma AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Pathologic Stage II Cutaneous Melanoma AJCC v8Stage II Differentiated Thyroid Gland Carcinoma AJCC v8Stage IIB Ovarian Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Cervical Cancer AJCC v8Stage III Colorectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (11)

  • 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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    Baseline up to 1 year

Secondary Outcomes (2)

  • Change in Quality of Life

    Baseline up to 1 year

  • Symptom Burden

    Baseline up to 1 year

Study Arms (1)

Observational (actigraph, surveys)

Patients complete surveys and wear an actigraph GT3X-BT accelerometer continuously for 7 days at baseline, 3, 6, and 12 months.

Other: Medical Device Usage and EvaluationOther: Quality-of-Life AssessmentOther: Survey Administration

Interventions

Wear an actigraph GT3X-BT accelerometer

Observational (actigraph, surveys)

Complete survey

Also known as: Quality of Life Assessment
Observational (actigraph, surveys)

Complete survey

Observational (actigraph, surveys)

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed and/or treated with cancer between ages 18-39 at University of Southern California (USC) hospitals.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsHodgkin DiseaseBone NeoplasmsBrain NeoplasmsTesticular NeoplasmsLymphoma, Non-HodgkinUterine Cervical NeoplasmsColorectal NeoplasmsOvarian NeoplasmsCarcinoma, Medullary

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone DiseasesMusculoskeletal DiseasesBrain DiseasesCentral Nervous System DiseasesEndocrine Gland NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesOvarian DiseasesAdnexal DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • Kimberly Miller, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

December 2, 2025

Study Start

November 24, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations