Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depressive Disorder

Depression

Psychotropic Drugs

All Drugs and Chemicals

Fluoxetine

* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.
* Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.

The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values

Behavioral Activation

Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.

Medication Optimization

Benjamin D Kozower, M.D., MPH

Simon Haroutounian, Ph.D., MSc

Kenneth Freedland, Ph.D.

Michael Avidan, MBBCh

Eric Lenze, M.D.

Joanna Abraham, Ph.D.

Katherine Holzer, Ph.D.

Thomas Kannampallil, Ph.D.

J. Philip Miller, Ph.D.

Mary Politi, Ph.D.

Ana Baumann, Ph.D.

Bethany Pennington, PharmD

Katherine Clifton, M.D.

Theresa Cordner

Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.

Study staff responsible for administering ratings throughout the study are blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated. This will allow to determine whether the blinding procedures in the study were effective.

Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery

* 9 item questionnaire with answers ranging from 0=not at all to 3=nearly every day.
* Scores represent: 0-5=mild, 6-10=moderate, 11-15=moderately severe, and 16-20=severe depression.

* 7 item questionnaire with answers ranging from 0=not at all to 3=nearly every day. Total score for the seven items ranges from 0 to 21.
* Scores 0-5=mild anxiety, 6-10=moderate anxiety, 11-15=moderately severe anxiety, and 15-21=severe anxiety.

National Institute of Mental Health (NIMH)

Washington University School of Medicine

Other Dietary Supplements

Amino Acids

Omega 3 Fatty Acid

Arginine

Glutamine

40 patients will be instructed to consume 600 ml of the special "immune-enhancing" formula plus 20 g glutamine (Supportan R + Glutamine plus R, which contain 900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3 fatty acids, in a lower volume due to its higher energy density).

40 patients that do not agree to participate, do not have enough time before the operation, do not tolerate the product and/or drink less than 100 cc/day.

600 ML OF AN ENERGY DENSE DRINK PLUS 20 G GLUTAMINE POWDER (to give 900 Kcal and 80 g protein/day)

SUPPORTAN + GLUTAMINE PLUS

Patients will be assessed and followed, but will receive no special nutritional support before the surgical procedure

NO PREOPERATIVE NUTRITION SUPPORT

María Pía de la Maza, M.D.

Daniel C. Bunout, M.D.

After surgical treatment, numerous trials using early postoperative enteral or parenteral nutritional support have been attempted, in order to reduce morbidity and mortality. Although it is difficult to compare among heterogeneous interventions, most of them have not been successful, a fact generally attributed to the timing of the intervention. On the other hand, nutrients that become "conditionally essential" under certain stressful circumstances, the so called nutraceuticals, have been incorporated into nutritional formulations. Both facts have prompted the idea of pre or perioperative nutrition support, using specific formulations called "immune enhancing" formulas, containing arginine, nucleotides, glutamine and omega3 fatty acids in varying concentrations. The provision of these nutraceuticals prior and early after the surgical, and particularly in oncologic surgery, theoretically permits to obtain adequate circulating and tissue concentrations for the moment when they are most needed. Exclusive postoperative provision of these substances would not be able to replenish depots and provide them for an adequate immune response and wound healing after surgery. However, regarding the preoperative approach, it is still not know which patients benefit more (less or more severely malnourished), which specific nutrient(s) are responsible for the positive effects, and the precise timing these nutrients should be provided. The present study aims to demonstrate that immune-enhancing formulas are superior to standard enteral products in reducing postoperative nutrition-related complications.

HYPOTHESIS:

Patients receiving enteral nutrition support with immune-enhancing formulas (containing higher concentrations of arginine, glutamine and omega 3 fatty acids compared with standard polymeric formulas) during 7 days before a major oncological surgical procedure, have a lower incidence of nutritional-related postoperative complications, compared with patients without preoperative nutritional supplementation or those supplemented with standard formulas.

OBJECTIVES:

* To put in practice a routine nutritional assessment for every patient that is going to be submitted to major digestive oncologic surgery
* In these patients evaluate adherence and tolerance of enteral drinks, comparing immune-enhancing with the standard polymeric formulations, during 7 days prior to surgery
* To compare frequency of postoperative nutrition-related complications (infections, anastomotic leaks and hospital length of stay), among non-supplemented patients and those receiving preoperative immune-enhancing or standard polymeric formulas.

PATIENTS AND METHODS:

Every patient proposed for major elective digestive oncologic surgery will be invited to a nutritional assessment. Exclusion criteria will be emergency surgery or renal failure (serum creatinine over 1.5 mg/dL). Some patients will not accept or will not be able to attend for several reasons, however they will be assessed by the clinical nutritionist the day of admission, before entering the OR, and followed as the other study patients, and will be considered the control group. Nutritional assessment will include clinical story, dietary recall, Global Subjective Assessment (GSA), calculation of percent weight loss respect habitual weight, anthropometric measurements (height, weight, body mass index) and hand grip strength. Functional involvement will be studied by the Karnofsky score. Among laboratory analysis total proteins, albumin, creatinine, BUN and blood cells for lymphocyte count will be included. All data will be registered in a special chart and then emptied in a computational data base.

After the nutritional assessment, both well nourished and undernourished patients will be instructed to consume an enteral drink, orally or by gastrostomy or enteral feeding tube, during 7 days before surgery. Seventy patients will receive 1 lt per day of a standard polymeric formula (Fresubin 22%, which gives 1000 Kcal and 35 g protein, does not contain free aminoacid nor omega fatty acids, and contains glutamine and arginine concentrations of milk proteins. In order to increase protein intake, 50 g /día of Proteinex R will be added in this group). The other 70 patients will be instructed to consume 600 ml of the special immune-enhancing formula plus 20 g glutamine (Supportan R + Glutamine plus R , which contain 900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3 fatty acids, in a lower volume due to its higher energy density). Both products are enriched with essential vitamins and minerals. The enteral formulas will be assigned through randomized computer-generated numbers, in an open way. Patients that do not agree to participate, do not have enough time before the operation, do not tolerate the product and drink less than 100 cc/day will be considered control subjects. The enteral products will be sold to the patients directly at the oncologic clinic, both the same prize, and lower to marketing prizes, due to the participation of Fresenius-Kabi in the protocol. However if the patients does not have the means, will receive it for free. All patients will be instructed to maintain their previous diet, adding the enteral supplement, or completing their requirement by tube feeding with standard or specific formulations (e.g. diabetic formulation).

All patients will be followed during the entire postoperative period, registering days of stay at the critical ward, time of mechanical ventilation, days of fever, infections (wound, intra-abdominal, pulmonary, urinary, etc), anastomotic leaks and time of hospitalization.

The participation of Fresenius-Kabi will consist of:

* Paying the enteral formulas, thus avoiding payment for patients (considering that Fundación Arturo Lopez Perez is a private institution, where patients must pay for their treatment, according to their health insurance, which usually exclude nutritional products).
* Collaboration with data registry (nutritional assessment, adherence to the supplements, postoperative complications, etc.) due to the incorporation of one of their professionals (nutritionist) to the study.

Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology

Preoperative Nutrition Support in Major Oncologic Surgery

Registration of all eventual surgical complication after oncologic surgery, both during hospital stay and after 30 days after hospital discharge

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery	NCT05685511	Older Adults Anxiety Depression Major Surgical ... Major Surgical ...	Behavioral Acti... Medication Opti...	60 Years -	Washington University School of Medicine
Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology	NCT01032512	CANCER	SUPPORTAN + GLU... NO PREOPERATIVE...	- 80 Years	University of Chile

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