Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors

Proportion of screen-eligible patients enrolled by consent

时间窗: Up to 2 years

Descriptive statistics will be used to compute the proportion of screen-eligible patients enrolled by consent. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.

Proportion of patients that complete all (five) study contacts of intervention

时间窗: Up to 2 years

Descriptive statistics will be used to compute proportion of patients that complete all (five) study contacts of the intervention. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.

Acceptability/Relevance of Intervention Sessions

时间窗: Up to 2 years

Will use qualitative interview to assess participants' perceptions of its acceptability/relevance of each of the six study contacts, using a Likert scale 0 to 10 with 0 being not at all satisfied/useful and 10 being completely satisfied/useful and an open ended question to understand why each score was provided. A composite score will be determined, where higher scores equate to higher acceptability/relevance. Descriptive statistics will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate. Qualitative responses will be analyzed for content.

Participation in aspects of protocol

时间窗: Up to 2 years

Will use qualitative interview to assess participants' engagement by review of task completion to participate in aspects of the protocol (as an indicator of participant burden). There are a total of six sessions to complete and seven videos to review. Descriptive statistics will be used to compute the proportion of participant self-reported effectiveness of each intervention via the logs. Completion of tasks indicates greater willingness to participate.

PROMIS Global Health10

时间窗: Baseline up to 1 month post-intervention

The PROMIS Global Health 10 is a well-established measure of health status in cancer survivors. It assesses health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Higher scores indicate better functioning. Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.

Use of proposed self-management strategies and perceived effectiveness

时间窗: Up to 2 years

Will use qualitative interview to assess participants' engagement by review of use of proposed self-management strategies and their perceived effect on quality of life concerns using a Likert scale 0 to 10 with 0 being not at all effective and 10 being most effective. Descriptive statistics will be used to compute the proportion of participant self-reported effectiveness of each intervention via the logs. Qualitative responses will be analyzed for content.

Medical Outcomes Survey Short-Form (SF-36)

时间窗: Baseline up to 1 month post-intervention

The SF-36 is a well-established measure of health status in cancer survivors. SF-36 includes one multi-item scale assessing eight health concepts: limitations in physical activity, social activity, role activity, bodily pain, psychological distress, limitations in social activity due to emotional distress, vitality, and general health perceptions. The scale ranges from 0-100. Higher scores indicate better functioning. Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.

(Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACT-Sp 12)

时间窗: Baseline up to 1 month post-intervention

The FACIT-SP-12 is the most widely used measure of spiritual well-being among those with cancer. Its subscales measure faith, meaning, and peace. Higher scores reflect higher well-being. Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.

MOS Modified Social Support Survey

时间窗: Baseline up to 1 month post-intervention

MOS assesses dimensions of social support with four functional support scales: emotional/informational, tangible, affectionate, and positive social interaction. The scale ranges from 0-100. Higher scores indicate greater social support. Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.

PROMIS Applied Cognition - General Concerns short form (8- item)

时间窗: Baseline up to 1 month post-intervention

This instrument measures working memory, speed of processing, and executive control of cognitive functioning. Higher scores reflect higher perceived cognitive functionality. Will use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.