Fatigue in Breast Cancer Patients Undergoing Radiotherapy-eSMART-MH

Breast Cancer Clinical Trial

Official title:

Fatigue in Breast Cancer Patients Undergoing Radiotherapy-Electronic Self-Management Resource Training for Mental Health (eSMART-MH)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02759549
• Other study ID #: IRB00028295
• Status: Withdrawn
• Phase: N/A
• First received: April 29, 2016
• Last updated: November 11, 2016
• Start date: September 2015

Study information

• Verified date: November 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews.

Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.

Description:

The purpose of this study is to determine if an avatar-based depression self-management intervention (eSMART-MH) once a week for the duration of the participant's radiation treatment will significantly reduce depressive symptoms. Investigators also seek to explore how women with breast cancer describe their mood using prompted and unprompted speech through electronic social media and interviews.

Participants will be randomized into the eSMART-MH group or the theater testing (attention control) group. In addition to the assigned interventions, participants will be asked to complete questionnaires and interviews with the study staff.

Participants will be enrolled within two weeks of radiotherapy. A preliminary depression survey (IDS-SR) will be given to assess depression. There will be a total of three routine study assessments, one within two weeks prior to the beginning of radiotherapy, one the last week of radiotherapy and one 5 - 7 weeks after radiotherapy is completed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients seen in the Emory Breast Center at The Emory Clinic and Emory Midtown Hospital who are treated with curative intent.

• Score of 8 or higher on the Inventory of Depressive Symptomology - Self Reported (IDS-SR) test

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Behavioral:
• eSMART-MH
eSMART-MH (Electronic Self-Management Resource Training for Mental Health) is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programmed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. eSMART-MH will be used once a week throughout the duration of radiation treatment.

Other:
• Mobile Mood Tracking (Mood 24/7)
Public social media data posted by participants will be accessed and downloaded to a computer program. Permission for the study team to access this data is optional.

Behavioral:
• Theater Testing Workshop
The theater testing workshop consists of one to two one-on-one sessions with study staff during which participants will review a computer program for its content and usability, as well as discuss areas for improvement. Participants will also be asked to complete questionnaires and a attend a brief interview regarding any suggested improvements for the computer program.

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Behavioral Activation for Depression Scale-Short Form (BADS-SF) Score	The BADS-SF is a 9-item self-report measures that assess behavioral activation which captures the domains of activation, avoidance/rumination, work/school impairment, and social impairment. The BADS-SF asks participants to respond to each statement over the past week, including the day in which they complete the measure, on a 0 to 6 likert type scale.The BADS-SF has shown to be significantly associated with depression.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Self-Efficacy for Managing Chronic Disease 6-Item Scale Score	The Self-Efficacy for Managing Chronic Disease questionnaire is a six item self-report scale. This measure asks how confident, on a scale of 1-10, the respondent is in doing certain activities pertaining to self-management. Scores range from 6 to 60. A higher score indicates more confidence.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Pediatric CARE measure 10 questions (PCM 10Q) Score	The PCM 10Q is used to gain the views of children or patients receiving health services. It is a patient-centered measure of relational empathy. It measures patients' experiences of the interpersonal aspects of clinical encounters.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Virtual Support Measure Score	The virtual support questionnaire is a measure of perceived virtual support of the avatars. Participants rate the "virtual support" provided by the avatar healthcare provider and avatar coach separately. The first 12 questions of the Virtual Support Questionnaire ask participants to rate, on a Likert-type format, the avatars on a variety of relational characteristics. Selection options range from (1) "No, not at all" to (5) "Yes, definitely." The last 10 items of the Virtual Support Questionnaire ask respondents to rate, using a Likert-type format, to what degree they agree or disagree with statements about how the avatars understood their experiences. Selection options ranged from (1) "Strongly agree" to (6) "Strongly disagree."	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in The University of California, Los Angeles (UCLA) Loneliness Scale Score	The UCLA Loneliness Scale is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either O ("I often feel this way"),S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). A higher score indicates more feelings of loneliness.This scale has a strong association with depression.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Patient Activation Measure (PAM-13) Score	The PAM-13 is a 13-item measure that assesses the patient's perception of their knowledge, skill, and confidence in self-management behavior. Scores range from 0-100, with a higher score indicating greater patient activation.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Quality of Patient-Provider Interaction Questionnaire (QPPI) Score	The QPPI is a 14-item self-report likert type style questionnaire that assesses from the patient's perspective the quality of the interaction between the patient provider.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Patient Self-Competence Subscale (PSCS) Score	A 16-item five point Likert scale that asks participants to rate items from 5 (important) to 1 (unimportant); a higher score indicates greater perceived self-competence and effective communication with a health care provider.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in FAS Verbal Fluency Test Score	The FAS Verbal Fluency Test task asks respondents to generate words beginning with the letters "F," "A," and "S" within 60 seconds. Adults with depression generate fewer words on the FAS than non-depressed.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in The State Hope Scale Score	The State Hope Scale is a a 6-item self-report scale which measures goal-directed thinking and the "here and now." Respondents are asked to respond to items in relation to what is "going on in your life right now" in response to goal-directed statements on a 1-8 scale.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Emotional Regulation Questionnaire (ERQ) Score	The ERQ is a 20-item scale that asks respondents how they manage and regulate their emotions in response to life events on a 1-7 likert-type scale.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Body Awareness Questionnaire Score	The Body Awareness Questionnaire is a an 18-item measure that asks respondents to rate their sensitivity to normal and non-emotional body processes on a 1-7 likert-type scale.	Baseline, Post Treatment (5-7 weeks)	No
Other	Change in Experiences Questionnaire (EQ) Score	The EQ is a 20 item self-report scale designed to measure decentering and deep thinking.	Baseline, Post Treatment (5-7 weeks)	No
Other	3 Item Functional Health Literacy Quick Screen	The 3 Item Functional Health Literacy Quick Screen is used to detect limited and marginal health literacy skills.	Baseline	No
Other	Tobacco Use Questionnaire	The Tobacco Use Questionnaire is two question self-report about the use of traditional cigarettes, or e-cigarettes, or both and the amount of cigarettes smoked.	Baseline	No
Other	Alcohol Use Disorders Identification Test (AUDIT)	The AUDIT simple brief assessment tool to screen for excessive drinking. The measure consists of 10 questions about recent alcohol use, alcohol dependence symptoms, and alcohol-related problems.	Baseline	No
Other	Adverse Childhood Event (ACE) Questionnaire	An ACE score is a tally of different types of abuse, neglect, and household dysfunction. There are 10 items on the measure; we will ask 9 of these questions, omitting the question about sexual abuse. The ACE Study emphasizes the number rather than categories of ACE that one has been subjected to. The number of the nine items of ACE that one has undergone (0-9) is regarded as the ACE score.	Post last intervention (4 week follow up)	No
Primary	Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score	The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI) Score	The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Perceived Stress Scale (PSS) Score	The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Short Form-36 (SF-36) Health Survey Score	The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score	The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. A score of 24 or more indicates active and substantial exercise benefits. A score of 23 units or less indicates insufficiently active and less substantial exercise benefits.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score	The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Lent Soma Scale Patient Questionnaire Score	The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Multidimensional Fatigue Inventory (MFI) Score	The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in The Centers for Disease Control (CDC) Health-Related Quality of Life-4 (QOL) Questionnaire Score	Quality of Life will be measured by the Center for Disease Control Health Related Quality of Life-4 (CDC HRQOL). This self-report measures quality of life over the last 30 days in the domains of physical and mental health.	Baseline, Post Treatment (5-7 weeks)	No
Secondary	Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score	The FACT-G is a self-reported measure of well being in the past seven days. Scores range from 0 to 27. A higher score indicates worse perception of well being.	Baseline, Post Treatment (5-7 weeks)	No