The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer

Breast Cancer Clinical Trial

— MEDITATE-BC  

Official title:

The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880799
• Other study ID #: EH18-203
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: January 2021
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the investigators propose to pilot test a brief, mindfulness shared decision making intervention that begins shortly after receiving a diagnosis of breast cancer. A mindfulness instructor will conduct an hour long session with consented participants before the scheduled surgical appointment. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety. To measure this endpoint, participants will complete three surveys via REDCap- at baseline, before surgery, and 6 months postoperatively. Surveys will include questions on quality of life, anxiety, and participant satisfaction with the mindfulness program.

Description:

The primary aim of this study is to identify if a mindfulness intervention is feasible before the participant has their surgical consultation. The secondary aim is to measure the impact of the mindfulness intervention on participant reported outcomes including anxiety, quality of life and decisional satisfaction. Newly diagnosed female breast cancer patients will be contacted over the phone after the patient learns of their diagnosis but prior to their surgical appointment to discuss surgical options. Verbal consent will be obtained over the phone and the participant will be directed to complete an online survey to answer baseline questions on their anxiety and quality of life as well as to provide their contact information and availability in order to schedule a mindfulness session with a certified mindfulness teacher. The participant will then proceed to an hour-long mindfulness exercise geared to help women apply these techniques to the decisional making process. The goal is to empower women to approach their diagnosis and treatment decisions with greater stability and improve their ability to focus on their values and preferences instead of just focusing on the diagnosis. This will be measured by administering patient reported outcomes (PROs) via REDCap online surveys at three timepoints. The first PRO "baseline survey" is administered after the participant enrolls but before the mindfulness session. The second PRO "before surgery survey" is completed after the surgical consultation but prior to the scheduled surgery. The final PRO "6-month survey" is administered 6 months after the surgery to measure quality of life, anxiety, and participant satisfaction with the mindfulness program. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 10, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Females >20 and < 70 years of age

2. History of contralateral breast cancer in the past is acceptable

3. Patients seeking second opinion for diagnosis are eligible

4. Clinical AJCC stage 0-III breast cancer

5. Patients who have an in breast tumor recurrence are eligible

6. English Speaking

7. Willing to fill out surveys required for the study

8. Gene mutation carriers are eligible

9. Neoadjuvant therapy patients are eligible

Exclusion Criteria:

1. AJCC Stage IV breast cancer

2. Unwilling to fill out surveys for the study

3. Patients with a distant recurrence

4. Patients unaware of their diagnosis

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

Intervention

Behavioral:
• Mindfulness Session
one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sepucha K, Ozanne E, Silvia K, Partridge A, Mulley AG Jr. An approach to measuring the quality of breast cancer decisions. Patient Educ Couns. 2007 Feb;65(2):261-9. Epub 2006 Oct 4. — View Citation

Yao K, Belkora J, Bedrosian I, Rosenberg S, Sisco M, Barrera E, Kyrillios A, Tilburt J, Wang C, Rabbitt S, Pesce C, Simovic S, Winchester DJ, Sepucha K. Impact of an In-visit Decision Aid on Patient Knowledge about Contralateral Prophylactic Mastectomy: A Pilot Study. Ann Surg Oncol. 2017 Jan;24(1):91-99. doi: 10.1245/s10434-016-5556-x. Epub 2016 Sep 21. Erratum in: Ann Surg Oncol. 2017 Mar 27;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention.	The number of patients who have successfully completed their mindfulness session with the mindfulness instructor. Zero being not one completion, twenty-five being all have completed the mindfulness session.	1 year
Primary	Acceptability of a mindfulness intervention following the surgical consultation measured by adherence to the follow up session.	The number of patients who have successfully completed their mindfulness follow up session with the mindfulness instructor. Zero being not one completion, twenty-five being all have completed the mindfulness session.	1 year
Primary	Participant feedback via Questionnaire on the usefulness of the mindfulness experience on their emotional management and decision making process.	Two sets of questions asking about level of satisfaction with the mindfulness experience and how it pertains to their treatment decision satisfaction with responses being; 1. Not at all, 2. A little bit, 3. Somewhat, 4. Quite a bit, 5. Very much;	1 year
Primary	Feasibility of a mindfulness intervention prior to the surgical consultation by a single question regarding mode of communication participants prefer.	Options include by phone, video conference, or in-person	1 year
Primary	Feasibility of a mindfulness intervention prior to the surgical consultation by calculating proportion of participants who consent to the study.	Measurement will be done by looking at the ratio of participants approached versus participants consented to the study.	1 year
Primary	Feasibility of a mindfulness intervention prior to the surgical consultation by proportion of participants who have contact with the mindfulness teacher.	Measurement will be done by looking at the ratio of participants consented versus participants completed the mindfulness intervention with the teacher.	1 year
Primary	Feasibility of a mindfulness intervention prior to the surgical consultation by measuring the length of time to schedule the participant with the mindfulness teacher.	This will be measured by comparing date the participant consented on the study to the date participant had successfully scheduled their mindfulness session.	1 year
Primary	Feasibility of a mindfulness intervention prior to the surgical consultation by adherence to the mindfulness excercises.	The mindfulness instructor will conduct a follow-up session with the participant following their surgical consultation and measure the number of times the participant listened to the audio recordings given to them following their mindfulness session but prior to their surgical consultation.	1 year
Secondary	Patient Reported Outcomes on anxiety	using the HOSPITAL ANXIETY AND DEPRESSION SCALE (HADS); multiple choice, 4 point range scale. Examples: a. Most of the time b. A lot of the time c. From time to time, occasionally d. Not at all	2 years
Secondary	Patient Reported Outcomes on fear of recurrence	using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Scale ranging from 1-strongly disagree to 5-strongly agree. Example: Because cancer is unpredictable, I feel I cannot plan for the future. (1 -Strongly Disagree,2- Disagree,3- Not Certain,4- Agree 5-Strongly Agree)	2 years
Secondary	Patient Reported Outcomes on quality of life	utilizing the LINEAR ANALOGUE SELF ASSESSMENT (LASA) scale; Scale ranging from 0-10 with 0-being as bad as it can be, and 10 being as good as it can be. Last question on anxiety is flipped, 0-being no anxiety, and 10-being anxiety is as bad as it can be.	2 years
Secondary	Patient Reported Outcomes on decisional satisfaction	Using the Decisional satisfaction questionnaire. Scale ranges 1-4 with 1-being very dissatisfied, to 4-very satisfied. Example: With your breast area in mind, in the past 2 weeks, how satisfied or dissatisfied have you been with How you look in the mirror clothed? 1-very dissatisfied 2-somewhat dissatisfied 3-somewhat satisfied 4-very satisfied;	2 years
Secondary	Patient Reported Outcomes on mindfulness outcome	using the Mindfulness outcome measures (MeditationHX) Scale Ranges from 1-5 (1-Not at all, 2-A little bit, 3-Somewhat, 4-Quite a bit, 5-Very much) Example: Overall, I am satisfied with my experience participating in this research program (1-Not at all, 2-A little bit, 3-Somewhat, 4-Quite a bit, 5-Very much)	2 years
Secondary	Patient Reported Outcomes and value concordant decision making	ratio measured by a formula used in previous studies	2 years

External Links

•   Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness.