Behaviors and Mental Disorders

All Conditions

Depression

Depressive Disorder

Affective Symptoms

Behavioral Symptoms

Patients assigned to the intervention arm will receive 3-6 CALM therapy sessions over 3-6 months delivered by a trained therapist at our center.

CALM

Gary Rodin

Sarah Hales

Chris Lo

Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to alleviate distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was associated with reductions in depressive symptoms and death anxiety and an increase in spiritual wellbeing. The purpose of this study is to assess the feasibility of a large-scale randomized controlled trial (RCT) of CALM and to identify preliminary effects in advanced cancer. This phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month follow-ups. The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes included diagnosis of major depression (SCID), death anxiety, attachment security and spiritual wellbeing. Multilevel regression was used to compare change over time between groups. 60 patients with advanced cancer will be recruited from the Princess Margaret Cancer Centre, Toronto, Canada, and equally randomized into intervention and usual care conditions.

Abstract

Background Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT).

Aims To test trial methodology and assess feasibility of a confirmatory RCT.

Design A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting.

Setting/participants 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre.

Trial registration number NCT02353546.

http://dx.doi.org/10.1136/bmjspcare-2015-000866

CALM Phase 2b Pilot

Managing Cancer and Living Meaningfully (CALM): Phase 2b Pilot Randomized Psychotherapy Trial in Patients With Advanced Cancer

DSM: Diagnostic and Statistical Manual of Mental Disorders (APA, 2000)

Canadian Institutes of Health Research (CIHR)

University Health Network, Toronto

Symptoms and General Pathology

Nausea

Vomiting

Signs and Symptoms, Digestive

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Emetics

Aprepitant

Gabapentin

Fosaprepitant

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.

Aprepitant vs. Gabapentin

Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.

Stanley Cheshire

1. To compare the effectiveness of gabapentin (titrated to300mg TID days -2 to 5) with aprepitant (125mg on day 1 and 80mg on days 2 and 3) in the control of delayed nausea and vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in patients who experienced delayed nausea and/or vomiting during their first cycle of chemotherapy.
2. To evaluate and compare the safety profile associated with each anti-emetic regimen.
3. To assess subject satisfaction with anti-emetic therapy.

The purpose of study is to compare the effectiveness of aprepitant and gabapentin in treating "delayed" (days later) nausea and/or vomiting for patients receiving chemotherapy treatment for cancer. Patients on the study will receive aprepitant or gabapentin in addition to the standard medications used to prevent nausea and vomiting. Aprepitant is approved by the FDA for nausea and vomiting. Gabapentin is approved by the FDA for the treatment of seizures but it may be effective in controlling nausea and vomiting due to chemotherapy. Subjects receiving aprepitant will be receiving a proven treatment for delayed nausea and vomiting, while subjects receiving gabapentin will be receiving a drug that has only shown limited effectiveness.

Patients are eligible for participation in this study because they are going to receive chemotherapy that may cause nausea or vomiting. If patients have delayed nausea or vomiting after the first cycle of treatment, they will be offered a chance to receive additional treatments with their second cycle of chemotherapy. The University of New Mexico Health Sciences Center is sponsoring the study.

The first 40 patients enrolled in the study will participate in the pilot phase of the study. A pilot study is a smaller version of a full study to determine how effective the treatments are. All 40 patients in the pilot phase of the study will come from UNM. If the pilot phase is found to be successful, then the study will continue and approximately 200 patients will eventually be enrolled. The full study will be conducted at the University of New Mexico Cancer Research and Treatment Center (UNM CRTC), the New Mexico VA Healthcare System, and at members of the New Mexico Cancer Care Alliance.

Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting

Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting

New Mexico Cancer Care Alliance

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CALM Phase 2b Pilot	NCT02353546	Depression	CALM	18 Years -	University Health Network, Toronto
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting	NCT00250744	Cancer	Aprepitant vs. ... Aprepitant vs. ...	18 Years -	New Mexico Cancer Care Alliance
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting	NCT00250744	Cancer	Aprepitant vs. ... Aprepitant vs. ...	18 Years -	New Mexico Cancer Care Alliance
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting	NCT00250744	Cancer	Aprepitant vs. ... Aprepitant vs. ...	18 Years -	New Mexico Cancer Care Alliance

Spots Global Cancer Trial Database for pilot trial

Every month we try and update this database with for pilot trial cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pilot trial

Every month we try and update this database with for pilot trial cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pilot trial cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.