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临床试验/NCT07259304
NCT07259304进行中(未招募)不适用

Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors: A Longitudinal Study

University of Southern California3 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2021年11月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
118
试验地点
3
主要终点
Change in social role functioning

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Observational (actigraph, surveys)

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

干预措施: Medical Device Usage and Evaluation (Other)

Observational (actigraph, surveys)

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

干预措施: Quality-of-Life Assessment (Other)

Observational (actigraph, surveys)

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

干预措施: Survey Administration (Other)

结局指标

主要结局

Change in social role functioning

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • Change in Quality of Life(Baseline up to 1 year)
  • Symptom Burden(Baseline up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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