- 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 the trajectories of social health in young adult (YA) cancer patients.
II. Investigate the longitudinal associations between social health and activity behaviors in YA cancer patients.
III. Explore the effects of sociodemographic and clinical characteristics on the relationship between social health, activity behaviors, and quality of life.
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 (Estimated)
Contacts and Locations
Study Contact
- Name: Kimberly A Miller, PhD
- Phone Number: 323-865-0674
- Email: kim.miller@med.usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- Recruiting
- USC / Norris Comprehensive Cancer Center
-
Contact:
- Kimberly Miller
- Phone Number: 323-865-0674
- Email: Kim.Miller@med.usc.edu
-
Principal Investigator:
- Kimberly Miller
-
Los Angeles, California, United States, 90033
- Recruiting
- Los Angeles General Medical Center
-
Contact:
- Kimberly Miller
- Phone Number: 323-865-0674
- Email: Kim.Miller@med.usc.edu
-
Principal Investigator:
- Kimberly Miller
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed and/or treated with cancer between ages 18-39 at USC hospitals.
- Cancer types prototypical for adolescents and young adults (AYAs) and cancer stages I-III; select patients with stage IV disease may be eligible, with approval by the principal investigator (PI) and in consultation with the treating clinician.
- Must be within three months of a de novo cancer diagnosis at recruitment and on/indicated for curative therapy (any modality). Patients may continue on adjuvant therapy throughout duration of the study.
- Patients must have anticipated survival of >1-year at time of diagnosis.
Exclusion Criteria:
- Diagnosis of blood malignancies such as leukemias (these cancers have divergent treatment patterns of longer duration than other cancers and are more commonly pediatric cancers). Some early stage lymphomas with favorable prognoses may be eligible, with approval by the PI and in consultation with the treating clinician.
- Primary language other than English or Spanish.
- Inability to complete a survey and/or wear an accelerometer either per the patient or in consultation with the clinician's judgment.
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 |
|---|---|---|
|
Rate of Change in trajectories of social health
Time Frame: Baseline up to 1 year
|
Social health variables include the number, frequency and duration of hospitalizations, specifics of cancer diagnosis (i.e., stage at diagnosis, pertinent histology, recurrence or progression of disease), chemotherapy type, surgery related to cancer diagnosis, radiation field, immunotherapy type, and other relevant therapies related to cancer treatment. Changes in above variables will be measured using latent growth curve models to measure latent intercept (initial level), and the latent slope (rate of change) of social health variables during the course of therapy. |
Baseline up to 1 year
|
|
Rate of Change in trajectories of physical activity
Time Frame: Baseline up to 1 year
|
Changes will be measured using latent growth curve models to measure latent intercept (initial level) and the latent slope (rate of change) of physical activity during the course of therapy.
|
Baseline up to 1 year
|
|
Rate of Change in trajectories of quality of life
Time Frame: Baseline up to 1 year
|
Changes will be measured using latent growth curve models to measure latent intercept (initial level) and the latent slope (rate of change) of quality of life during the course of therapy.
|
Baseline up to 1 year
|
|
Moderation by gender
Time Frame: Up to 1 year
|
Will conduct multi-group analyses by the categories of study moderators (e.g., gender, race/ethnicity, socioeconomic status [SES], health status).
The strengths of group-specific pathways to link social health and activity behaviors to quality of life will be compared using the chi-square (χ2) difference test of model fit.
The log-likelihood values with (versus [vs.] without) the equality constraints on the group-specific pathways to determine if the strength of associations estimated in the models significantly differ by the groups of each moderator (e.g., gender: female vs. male).
|
Up to 1 year
|
|
Moderation effect of race/ethnicity
Time Frame: Up to 1 year
|
Moderation effect is analyzed by the interaction between the independent variable (X), and the moderator variable (Y) in a regression model, where the endpoint is the dependent variable (Z).
Moderation effect is the endpoint itself, indicated by the significance of the interaction term's regression coefficient (B3), which shows how the relationship between X and Y changes depending on the level of Z. 'X' is social health, physical activity, and quality of life.
'Y' is race/ethnicity.
'Z' is moderation effect.
The strengths of group-specific pathways to link social health and activity behaviors to quality of life will be compared using the chi-square (χ2) difference test of model fit.
|
Up to 1 year
|
|
Moderation effect of Socio-Economic Status (SES)
Time Frame: Up to 1 year
|
Moderation effect is analyzed by the interaction between the independent variable (X), and the moderator variable (Y) in a regression model, where the endpoint is the dependent variable (Z).
Moderation effect is the endpoint itself, indicated by the significance of the interaction term's regression coefficient (B3), which shows how the relationship between X and Y changes depending on the level of Z. 'X' is social health, physical activity, and quality of life.
'Y' is socio-economic status.
'Z' is moderation effect.
The strengths of group-specific pathways to link social health and activity behaviors to quality of life will be compared using the chi-square (χ2) difference test of model fit.
|
Up to 1 year
|
|
Moderation effect of health status
Time Frame: Up to 1 year
|
Moderation effect is analyzed by the interaction between the independent variable (X), and the moderator variable (Y) in a regression model, where the endpoint is the dependent variable (Z).
Moderation effect is the endpoint itself, indicated by the significance of the interaction term's regression coefficient (B3), which shows how the relationship between X and Y changes depending on the level of Z. 'X' is social health, physical activity, and quality of life.
'Y' is health status.
'Z' is moderation effect.
The strengths of group-specific pathways to link social health and activity behaviors to quality of life will be compared using the chi-square (χ2) difference test of model fit.
|
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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