The purpose of the study is to:Translate a mindfulness program into Spanish for Latina patients with breast cancer.Train a community health worker to facilitate the mindfulness program. Determine if this program is culturally acceptable and feasible, and Obtain pilot data on the program's effectiveness in reducing anxiety and depression
Primary aims of this study are to: 1) translate a behavioral health intervention into Spanish, 2) deliver it to a population of Spanish speaking Latina breast cancer patients, and 3) determine acceptability and feasibility. Secondary aims are to gather preliminary data on anxiety, depression and sleep quality pre and post intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
31
6 weekly 2.0 hour video-conferenced group sessions with the following components: 1) short grounding meditation, 2) check in/review of prior weeks practice and symptoms, 3) educational topic, 3) main meditation, 4) reflection on meditation, and 5) action plan formation
Wait list control
Stanford University
Palo Alto, California, United States
Acceptability change across session
The Acceptability scale was developed for this study and is a 5 point Likert scored scale that will be administered after end of each weeks for 6 weeks. There are two questions with scores ranging from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 8 with the higher scores representing greater levels of acceptability. It has 2 additional open ended questions: "What changes did you make in your daily routine as a result of this intervention, if none, why" and "Were there any barriers to making changes you listed on your action plan, if so what were they? The scale takes approximately 5 minutes to complete. Acceptability change will be measured after each session (week 1-6). The mean score with standard deviation for each 6 sessions and acceptability will be reported.
Time frame: End of each week for 6 weeks
Difference in Feasibility
The Feasibility and Satisfaction scale was developed for this study and is a 5 point Likert scored scale that will be administered at at time of completion of intervention or at time of withdraw (if participant withdraws prior to completion of intervention.) Five questions are scored from "strongly disagree" (score 0), "disagree" (score 1), "neutral" (score 2), "agree" (score 3), and "strongly agree" (score 4). Scores range from 0 to 20 with higher scores representing greater levels of feasibility. Differences in Feasibility will be evaluated and reported. There is also 1 open-ended question "What is the optimal number of visits" with continuous numeric score (participants able to write in number of preferred visits) with higher score representing desire for greater number of visits. The scale takes approximately 5-10 minutes to complete
Time frame: Through study completion, an average of 1 year
Differences in Generalized Anxiety Disorder-7 (GAD7) between time points.
The GAD7 is a well validated seven-item self-administered questionnaire used to measure anxiety. It has 7 questions with Likert scores ranging from "not at all" (score 0), "several days" (score 1), "more than half the days" (score 2), and "nearly every day (score 3).Scores range from 0 to 21 with higher scores indicating higher levels of anxiety, and a cutoff of or above 10 representing high likelihood of generalized anxiety disorder. Difference in GAD-7 measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be compared and reported. The scale takes approximately 5-10 minutes to complete
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Time frame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Differences in Center for Epidemiological Studies-Depression (CES-D) between time points.
The CES-D scale is a well validated self-administered questionnaire used to measure depression. The 20 item scale has Likert scores ranging from "rarely or none of the time" (score 0), "some or little of the time" (score 1), "moderate or much of the time" (score 2), and "most or almost all the time" (score 3).Scores range from 0 to 60 with higher scores indicated greater depressive symptoms. A cut off at or above 20 has sensitivity 79% and specificity of 80% for major depression. Difference in CES-D measured at three time points (week 1 and 6 of the intervention and 3 months post intervention) will be reported and compared. The scale takes approximately 5-10 minutes to complete.
Time frame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)
Differences in PROMIS-SD between time points
The Participant Reported Outcomes Measurement Information System (PROMIS) Adult Short Form: Sleep Disturbance (PROMIS-SD), is an 8 item scale measuring overall sleep quality, disturbances, and satisfaction over the past 7 days on 5 point Likert scale with scores ranging from 1 to 5. Raw scores are converted into t scores ranging from 28.9 to 76.5, with higher scores indicating greater sleep disturbance. Exploratory analysis will compare scores at three time points (week 1 and 6 of the intervention and 3 months post intervention). The scale takes approximately 2 minutes to complete 26 and is available in Spanish.
Time frame: Three time points (week 1 and 6 of intervention, and 3 months post intervention.)