- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259304
Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors
Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors: A Longitudinal Study
Study Overview
Status
Conditions
- Malignant Solid Neoplasm
- Hodgkin Lymphoma
- 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
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Non-Hodgkin Lymphoma
- Stage III Uterine Corpus Cancer AJCC v8
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
- Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Clinical Stage I Cutaneous Melanoma AJCC v8
- Clinical Stage IA Cutaneous Melanoma AJCC v8
- Clinical Stage IB Cutaneous Melanoma AJCC v8
- Clinical Stage II Cutaneous Melanoma AJCC v8
- Clinical Stage IIA Cutaneous Melanoma AJCC v8
- Clinical Stage IIB Cutaneous Melanoma AJCC v8
- Clinical Stage IIC Cutaneous Melanoma AJCC v8
- Pathologic Stage I Cutaneous Melanoma AJCC v8
- Pathologic Stage IA Cutaneous Melanoma AJCC v8
- Pathologic Stage IB Cutaneous Melanoma AJCC v8
- Pathologic Stage II Cutaneous Melanoma AJCC v8
- Pathologic Stage IIA Cutaneous Melanoma AJCC v8
- Pathologic Stage IIB Cutaneous Melanoma AJCC v8
- Pathologic Stage IIC Cutaneous Melanoma AJCC v8
- Pathologic Stage III Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Stage I Colorectal Cancer AJCC v8
- Stage II Colorectal Cancer AJCC v8
- Stage IIA Colorectal Cancer AJCC v8
- Stage IIB Colorectal Cancer AJCC v8
- Stage IIC Colorectal Cancer AJCC v8
- Stage I Cervical Cancer AJCC v8
- Stage IA Cervical Cancer AJCC v8
- Stage IA1 Cervical Cancer AJCC v8
- Stage IA2 Cervical Cancer AJCC v8
- Stage IB Cervical Cancer AJCC v8
- Stage IB1 Cervical Cancer AJCC v8
- Stage IB2 Cervical Cancer AJCC v8
- Stage II Cervical Cancer AJCC v8
- Stage IIA Cervical Cancer AJCC v8
- Stage IIA1 Cervical Cancer AJCC v8
- Stage IIA2 Cervical Cancer AJCC v8
- Stage IIB Cervical Cancer AJCC v8
- Stage III Cervical Cancer AJCC v8
- Stage IIIA Cervical Cancer AJCC v8
- Stage IIIB Cervical Cancer AJCC v8
- Stage IIIA Uterine Corpus Cancer AJCC v8
- Stage IIIB Uterine Corpus Cancer AJCC v8
- Stage IIIC Uterine Corpus Cancer AJCC v8
- Stage IIIC1 Uterine Corpus Cancer AJCC v8
- Stage IIIC2 Uterine Corpus Cancer AJCC v8
- Malignant Brain Neoplasm
- Stage III Ovarian Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Central Nervous System Neoplasm
- Stage III Differentiated Thyroid Gland Carcinoma AJCC v8
- Stage III Thyroid Gland Medullary Carcinoma AJCC v8
- Stage I Uterine Corpus Cancer AJCC v8
- Stage IA Uterine Corpus Cancer AJCC v8
- Stage IB Uterine Corpus Cancer AJCC v8
- Stage II Uterine Corpus Cancer AJCC v8
- Malignant Testicular Neoplasm
- Stage II Ovarian Cancer AJCC v8
- Stage IIA Ovarian Cancer AJCC v8
- Stage IIB Ovarian Cancer AJCC v8
- Stage I Ovarian Cancer AJCC v8
- Stage IA Ovarian Cancer AJCC v8
- Stage IB Ovarian Cancer AJCC v8
- Stage IC Ovarian Cancer AJCC v8
- Malignant Bone Neoplasm
- Stage I Differentiated Thyroid Gland Carcinoma AJCC v8
- Stage I Thyroid Gland Medullary Carcinoma AJCC v8
- Stage II Differentiated Thyroid Gland Carcinoma AJCC v8
- Stage II Thyroid Gland Medullary Carcinoma AJCC v8
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90033
- Los Angeles General Medical Center
-
-
Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (actigraph, surveys)
Patients complete surveys and wear an actigraph GT3X-BT accelerometer continuously for 7 days at baseline, 3, 6, and 12 months.
|
Complete survey
Wear an actigraph GT3X-BT accelerometer
Complete survey
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
|
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).
|
Baseline up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life
Time Frame: Baseline up to 1 year
|
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).
|
Baseline up to 1 year
|
|
Symptom Burden
Time Frame: Baseline up to 1 year
|
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.
|
Baseline up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kimberly Miller, PhD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Bone Diseases
- Musculoskeletal Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Uterine Diseases
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Colonic Diseases
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Carcinoma
- Uterine Cervical Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Lymphoma
- Nervous System Neoplasms
- Uterine Neoplasms
- Neuroendocrine Tumors
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma, Neuroendocrine
- Testicular Diseases
- Hemic and Lymphatic Diseases
- Colorectal Neoplasms
- Ovarian Neoplasms
- Uterine Cervical Neoplasms
- Lymphoma, Non-Hodgkin
- Hodgkin Disease
- Brain Neoplasms
- Central Nervous System Neoplasms
- Carcinoma, Medullary
- Testicular Neoplasms
- Bone Neoplasms
Other Study ID Numbers
- 0S-20-10 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2021-05723 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R37CA256867 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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