Symptoms and General Pathology

All Conditions

Recurrence

Fatigue

Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.

Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.

Placebo Administration

Quality-of-Life Assessment

Questionnaire Administration

Waiting List

Sriram Yennu

This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.

PRIMARY OBJECTIVE:

I. To determine the effects of open labeled placebo one tablet twice a day (OLP) compared to waitlist control (WLC) for reducing cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale in fatigued advanced cancer patients at the end of one week.

SECONDARY OBJECTIVES:

I. To determine the preliminary efficacy open labeled placebo (OLP) and WLC on various fatigue dimensions - (Multidimensional Fatigue Symptom Inventory, MFSI-SF), depression (The Center for Epidemiologic Studies - Depression \[CES-D\]), cancer symptoms (Edmonton Symptom Assessment System \[ESAS\]), function and strength (six minute walk test, and 30-sec chair stand test), Global Symptom Evaluation (GSE), and quality of life (Functional Assessment of Cancer Therapy - General \[FACT-G\]) in these advanced cancer patients.

II. To determine effects of OLP on fatigue symptom composite score (ESAS fatigue, pain and depression) at the end of 1st and 4th week.

III. To examine the adherence and safety for the OLP as treatment for cancer related fatigue.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive open labeled placebo orally (PO) twice daily (BID) for 4 weeks in the absence of disease progression.

ARM II: Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.

Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer

Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer

Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups.

Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups. The percentage of patients who report 'better' in each group will be reported. Will also compare the % of patients who report 'somewhat better' to "a great deal better" in each group and report the difference between groups (chi-square tests).

The primary comparison will be using changes in cluster composite scores of sleep disturbance from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.

The primary comparison will be using changes in cluster composite scores of fatigue from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.

The primary comparison will be using changes in cluster composite scores of pain from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.

The primary comparison will be using changes in cluster composite scores of depression from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.

Will use a chi-square to test the difference in adherence between each placebo group versus waitlist control group.

Will calculate the chi-square statistic to test the difference in adverse events between placebo group versus waitlist control group.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Participants attend ECHO telementoring sessions over 1 hour weekly for 13 weeks.

Participants are placed on a wait-list for 13 weeks and then attend ECHO telementoring sessions over 1 hour weekly for 13 weeks.

Communication Intervention

Eduardo Bruera

This trial studies how well the Extension for Community Healthcare Outcomes (ECHO) telementoring intervention works in transforming professional engagement, practice efficiency, and community building through team meetings in diagnostic imaging clinicians. This study may help researchers learn more about the potential benefits of a model for team meetings aimed at bringing physicians together from multiple practice locations when few opportunities exist for meaningful, collegial interactions. It may also help diagnostic imaging clinicians engage more effectively with colleagues at distant sites and become more engaged with their work.

PRIMARY OBJECTIVE:

I. To determine the feasibility of the proposed anti-burnout intervention for faculty at MD Anderson, defined as at least 35/50 of participants each attending at least 9 out of 13 sessions.

SECONDARY OBJECTIVES:

I. To explore any changes in burnout, measured by the Maslach Burnout Inventory (MBI) and Mini-Z surveys.

II. To explore any changes in the self-reported health status of participants, as measured by the RAND Short-Form 36 (SF36) survey.

III. To understand participants' perception of the benefits and usefulness of the intervention, measured by the customized Globalized Perception/Impression of Benefits Survey.

IV. To define methods for improving the intervention, based on participants' feedback following each session.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants attend ECHO telementoring sessions over 1 hour weekly for 13 weeks.

ARM B: Participants are placed on a wait-list for 13 weeks and then attend ECHO telementoring sessions over 1 hour weekly for 13 weeks.

Telementoring Intervention (ECHO) for the Transformation of Professional Engagement, Practice Efficiency, and Community Building Through Team Meetings in Diagnostic Imaging Clinicians

Transforming Professional Engagement, Practice Efficiency, and Community Building Through Team Meetings in a Telementoring Environment

Will be evaluated by attendance records for each session. Will estimate the attendance rate (p = proportion of participants attending at least 9 out of 13 sessions) with 95% confidence intervals.

Nervous System Diseases

Rare Diseases

Chronic Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Participants are linked to online informative videos on chronic pain produced by the Multidisciplinary Pain Centre (Rigshospitalet, DK). Ten video-modules of 2-6 minutes each. 1. Chronic pain development in Denmark, treatment offered at the Centre. 2. How chronic pain can affect life in all its facets. Chronic complex pain explained. 3. Psychological models used to describe affected life domains. The role of dysfunctional thoughts on e.g. anxiety. 4. The connection between pain and factors that can reduce energy level. 5. Pain interference in the familiar dynamic and relations. 6. Information about how to balance activity and rest - and on daily breathing exercises. 7. The Rules and opportunities when health challenges working life e.g. work relocation. 8. The importance of healthy habits regarding eating, sleep, and self-treating. 9. Selection of medication according to the patient's quality of life. 10. Expected side effects of medication and on measures to counteract side effects.

Participants will attend a single-session, 2-hour online group class. The program has two main components: didactics and skills acquisition. Participants will learn about pain self-regulation and self-management. The program content includes strategies to empower individuals with chronic non-cancer pain as following: 1) the identification of unhelpful thought patterns in the moment, 2) regulation of cognition and emotion, including thought reframing and mindset, 3) how to decrease physiological hyperarousal using relaxation techniques (binaural relaxation audio file for diaphragmatic breathing and progressive muscle relaxation), and 4) establishing self-soothing actions. At the end of the class, participants will develop a self-tailored plan for implementing these skills/strategies in daily life to use behaviors that modulate attention and counteract helplessness (Darnall et al 2014). The online class will be delivered by a nurse certified in the ER.

Participants in the control group will not receive any of the interventions. This project will not interfere with any current or future pain treatment. After the end of collecting data, the Multidisciplinary Pain Centre will eventually make available the videos that compose VP to all patients.

Educational videos with 10 modules with information about pain.

Educational Video-based Pain Program

Empowered Relief Program

Geana Kurita, PhD

Suzanne Herling, PhD

Geana Kurita, PHD.

Suzanne Herling, PHD

The development of alternative methods to address simple clinical needs and easy interventions of self-application are desired in the pre-habilitation period (waiting list). To our knowledge that are very few studies regarding interventions for patients in waiting list for specialized treatment of chronic non-cancer pain (CNCP) and they do not include cognitive-behavioural programs. This project is based on the hypothesis that educational and cognitive-behavioural interventions help to reduce deleterious effects of pain on some areas of patient's life. Therefore, the goal is to test two different interventions to help patients to self-manage their pain and avoid worsening in the pre-clinical period.

It is a randomized controlled trial for application and assessment of two interventions: an educational Video-based Pain Program (VP) and Empowered Relief Program (ER). The primary purpose of our study is to investigate the effect of ER and VP on the Pain Catastrophizing Score in people with CNCP who are waiting for Multidisciplinary pain treatment. The secondary aim is to analyse the effects on other patient reported outcomes such as pain intensity, pain interference in daily activities, pain catastrophizing, pain acceptance, quality of life, mood, perceived change on over-all pain status, as well as consumption of pain medicine and usage of healthcare services. The effects of the two interventions will be compared with each other and a control group.

Randomized controlled trial for application and assessment of the two interventions. Patients waiting for multidisciplinary pain treatment at Rigshospitalet and Herlev/Gentofte Hospital will be invited to participate and randomly assigned to one of three arms (1:1:1): VP group, ER group or control group (no intervention). Assessments will occur at baseline, 2 months, 6 months, and 12 months after the intervention.

Statistical analysis of data will be blinded.

Pre-habilitation Interventions to Empower Patients With Chronic Pain

One general question about satisfaction with the intervention used (6-point scale) and additional comments.

Pain catastrophizing in the last 24 hours; Pain Catastrophizing Score

Brief Pain Inventory to measure pain intensity and interference on general activity, mood, walking ability, work, social relations, sleep, and enjoyment of life with other.

Chronic Pain Acceptance Questionnaire to assess engagement in activity (despite pain), pain willingness, and total pain acceptance score.

The Measure Yourself Medical Outcome Profile (MYMOP 2), which measures effects on patient self generated outcome on physical, emotional, or social symptoms/problems. It is problem-specific and includes general wellbeing.

RAND 36-Item Short Form Health Survey version 1.0 to assess physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.

General Anxiety Disorder - 7 (GAD-7) is commonly used as a measure of general anxiety severity.

Patient Health Questionnaires scale (PHQ-9) can help track a patient's overall depression severity as well as track the improvement of specific symptoms with treatment.

Medication used (type and quantity), the number of times that he/she used the health care system because of chronic pain problem and treatment received (pharmacologic, surgical, rehabilitation, etc.), and number of absent days at work because of pain.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer	NCT03927885	Advanced Malign... Metastatic Mali... Recurrent Malig...	Placebo Adminis... Quality-of-Life... Questionnaire A... Waiting List	18 Years -	M.D. Anderson Cancer Center
Telementoring Intervention (ECHO) for the Transformation of Professional Engagement, Practice Efficiency, and Community Building Through Team Meetings in Diagnostic Imaging Clinicians	NCT04196972	Hematopoietic a... Malignant Solid...	Communication I... Questionnaire A... Waiting List	18 Years -	M.D. Anderson Cancer Center
Pre-habilitation Interventions to Empower Patients With Chronic Pain	NCT05178082	Chronic Non-Can...	Educational Vid... Empowered Relie...	18 Years -	Rigshospitalet, Denmark

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