Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Fatigue

Breast Neoplasms

Pain, Postoperative

Pain

Breast Diseases

Skin Diseases

Postoperative Complications

Neurologic Manifestations

Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery

Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery

Single session 20 minutes hypnosis session originally developed and tested by Montgomery et al. (2007) in a similar setting. Delivered by an experienced clinical psychologist.

Medical hypnosis

Access to an online platform developed to this study containing video clips and audio files with ACT consistent material

Internet-based Acceptance and Commitment Therapy (iACT)

Single session mindfulness session delivered by audio file

Mindfulness session

Treatment as usual as part of post-surical care

Treatment as Usual (TAU)

Silje E Reme, PhD

Henrik B Jacobsen, PhD

The study aims to investigate whether a combined pre-operative medical hypnosis plus a post-operative internet-based acceptance and commitment intervention are more effective in preventing post-surgical pain and fatigue following breast cancer surgery compared with pre-operative mindfulness plus treatment as usual.

The trial will include 200 patients undergoing breast cancer surgery at Oslo University Hospital. The patients will be randomized into two groups. One group will receive a 20 minute pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a post-surgical internet-based acceptance and commitment intervention. The control group will receive a 20 minute pre-surgical mindfulness session delivered through an audio recording plus treatment as usual. The primary outcomes of the study are quantitative measures of post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples. The study uses a longitudinal design with baseline measures obtained pre-surgery and follow up measures obtained 3 and 12 months post-surgery.

Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.

The intervention group vs. active control group status will be known to the participants and the health care personnel delivering the interventions. However, the investigator, outcome assessor and the additional health care personnel at the unit will be masked to the conditions.

Eligible participants are women (biological sex) diagnosed with breast cancer

Psychological Interventions to Prevent Late Effects in Breast Cancer

Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial

The study protocol, along with the intervention protocols, will all be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, data files involving questionnaire and biomarker data will be made available upon reasonable request. Due to privacy concerns, the complete data files will not be shared online.

Measured through a Numeric Rating Scale (NRS) for pain intensity. The scale ranges from 0-10, anchored by verbal descriptors at either end of the scale where 0 is no pain at all and 10 is the worst possible pain.

Measured through the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F) which is a unidimensional self-report scale to assess fatigue and its impact on daily life. The score range is 0-52 where a higher score indicates better quality of life (i.e. less symptoms and disability)

Measured by a Visual Analogue Scale (VAS) (to replicate a previous hypnosis trial - Montgomery et al 2007). The range is 0-100 where a higher score indicates more intense symptoms.

Immune function is assessed through whole blood samples using the standardized TruCulture system that contains immunogenic stimuli (infected tubes). This test will reveal the induced innate and adaptive immune response in whole blood after stimulation with LPS, by quantifying the release of soluble immune activation products (cytokines, chemokines, soluble receptors etc.) in the supernatant and by measuring the transcription level (mRNA) in the circulating blood (immune) cells.

Usage of psychotropic and pain medication obtained through registry data from the Norwegian Prescription Database at 3 and 12 months follow-up. Number of prescriptions will be summarized and compared between intervention and control group.

Days away from work on sick leave will be measured through registry data

Measured through the Acceptance and Action Questionnaire (AAQ-II). The scale ranges from 7-49, where higher score indicates more psychological inflexibility

Measured through the Hospital Anxiety and Depression Scale (HADS). The total score ranges from 0-42, where a higher score indicates more symptoms

Oslo University Hospital

University of Oslo

Professor

Newly diagnosed breast cancer patients who undergo a mindfulness session before their surgical appointment.

one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient

Mindfulness Session

Katharine Yao, MD

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.

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.

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

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.

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.

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;

Options include by phone, video conference, or in-person

Measurement will be done by looking at the ratio of participants approached versus participants consented to the study.

Measurement will be done by looking at the ratio of participants consented versus participants completed the mindfulness intervention with the teacher.

This will be measured by comparing date the participant consented on the study to the date participant had successfully scheduled their mindfulness session.

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.

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

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)

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.

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;

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)

ratio measured by a formula used in previous studies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Psychological Interventions to Prevent Late Effects in Breast Cancer	NCT04518085	Pain, Postopera... Fatigue Breast Cancer	Medical hypnosi... Internet-based ... Mindfulness ses... Treatment as Us...	18 Years - 70 Years	University of Oslo
The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer	NCT03880799	Breast Cancer Surgery	Mindfulness Ses...	20 Years - 70 Years	NorthShore University HealthSystem
Psychological Interventions to Prevent Late Effects in Breast Cancer	NCT04518085	Pain, Postopera... Fatigue Breast Cancer	Medical hypnosi... Internet-based ... Mindfulness ses... Treatment as Us...	18 Years - 70 Years	University of Oslo

Spots Global Cancer Trial Database for mindfulness session