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NCT ID: NCT03522467 Not yet recruiting - Cancer Clinical Trials

Cannabis Oil for Pain Effectiveness

COPE
Start date: June 2018
Phase: Phase 2
Study type: Interventional

This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.

NCT ID: NCT03520959 Not yet recruiting - Cancer Clinical Trials

Synovate Study for Synovial Sarcoma

Start date: June 2018
Phase: Phase 3
Study type: Interventional

To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.

NCT ID: NCT03518255 Not yet recruiting - Cancer Clinical Trials

e-Natureza Project - Affective Validation of Nature Images for Hospital Use

E-natureza
Start date: May 30, 2018
Phase: N/A
Study type: Interventional

Randomized clinical trial about the evaluation of the use of nature photographs in the positive and negative affects of oncological patients.

NCT ID: NCT03514680 Not yet recruiting - Cancer Clinical Trials

Evaluating a Clinician Support Algorithm to Enhance Implementation of Evidence-Based Chemotherapy-Induced Peripheral Neuropathy Assessment and Management Recommendations

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

This research study is evaluating how well a decision support tool works to improve clinicians' use of recommended chemotherapy-induced peripheral neuropathy (CIPN) assessment and management strategies in participants receiving chemotherapy.

NCT ID: NCT03507491 Not yet recruiting - Cancer Clinical Trials

Nab-paclitaxel in Combination With Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors

Start date: May 2018
Phase: Phase 1
Study type: Interventional

This is a research study for people who have a solid tumor that was not effectively treated by conventional therapy or for which there is no known effective therapy. This is a phase I study of a drug called nab-paclitaxel used together with gemcitabine. Gemcitabine and nab-paclitaxel will be given intravenously, once a week for 3 out of 4 weeks, for a 28-day cycle. The goals of this study are: - To find the highest dose of nab-paclitaxel that can be safely given in combination with gemcitabine without causing severe side effects - To learn what kind of side effects nab-paclitaxel given in combination with gemcitabine can cause - To learn more about the pharmacology (how the body handles the drug) of nab- paclitaxel given in combination with gemcitabine - To evaluate tumor tissue for levels of certain proteins that may help with predicting who will benefit most from treatment with nab-paclitaxel - To determine whether nab-paclitaxel given in combination with gemcitabine is a beneficial treatment for relapsed and/or refractory solid tumors

NCT ID: NCT03506815 Not yet recruiting - Cancer Clinical Trials

Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines

TRIM-Line
Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

Purpose of Pilot Trial To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism(VTE) among cancer patients. Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC. Design: This is a pilot interventional study to be conducted at 3 Canadian Centres. The Ottawa Hospital, QEII Health Science Centre and University of Alberta Hospital. It is an open label randomized controlled trial. Consenting participants, meeting eligibility criteria will be randomized at the time of enrollment to one of two groups. Rivaroxaban 10mg po daily x 90 (+/- 3 ) days OR Standard of Care Participants in the treatment arm will have study drug dispensed at Day 1 and take medication for 90 days. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days) month and 3 months post enrollment. Overall, participants will be followed for 3 months. Adverse events will be collected for the first 90 days. Outcomes The primary feasibility outcome for the pilot study is the number of participants recruited per centre per month. We will obtain baseline details of the patient's type, location and treatment of cancer, comorbidities and medications. Secondary feasibility outcomes of the pilot study will include, consent rates, loss to follow up, adherence to therapy defining 80% or greater medication taken as having good adherence to study drug, proportion of screened patients who meet eligibility criteria.

NCT ID: NCT03494166 Not yet recruiting - Cancer Clinical Trials

Post-chemotherapy Symptom Management SMART

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Sample: The sample will be 344 ethnically diverse (at least 30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression and co-morbid illnesses. Design: The SMART design incorporates two interventions with proven efficacy and addresses heterogeneity of survivors' responses by following the clinical logic of starting with one intervention, assessing its success, and continuing it when effective. High need survivors will be initially randomized to receive 1) weekly symptom assessment with referral for elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a more intensive intervention adding SMSH to Telephone Interpersonal Counselling (TIP-C). After 4 weeks, non-responders to SMSH alone on depression will be re-randomized to continue SMSH for 8 more weeks to allow for symptom resolution, or TIP-C will be added for the remaining 8 weeks. Specific Aims: 1. Test the effects of interventions on summed index of severity of 15 post-chemotherapy symptoms (primary outcome) and symptom-specific responses and times to response (secondary outcomes). Hypothesis 1.Survivors that starts with TIP-C+SMSH versus those that start with SMSH alone created by the first randomization will have better primary and secondary outcomes at weeks 1-13. Hypothesis 2. Among nonresponders to the SMSH alone after 4 weeks, survivors in TIP-C+SMSH as compared to the SMSH alone group created by the second randomization will have better primary and secondary outcomes at weeks 5-13. Hypothesis 3. Self-efficacy and social support will mediate improvements in the primary outcome at week 13. Aim 2. Compare symptom outcomes of intervention sequences against the benchmark low need group. Exploratory Aim. Explore which survivor characteristics are associated with responses to the SMSH alone during weeks 1-4 and optimal symptom outcomes during weeks 1-13. This will allow us to determine tailoring variables to inform decision rules for choosing intervention sequences for individual survivors in the future.

NCT ID: NCT03479151 Not yet recruiting - Cancer Clinical Trials

Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU) for Pain Palliation of Bone Metastases

HIFU-Bone
Start date: April 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine whether intra- and post-procedural MR changes are indicative of reduction in pain symptom scores. The trial will recruit a cohort of patients with painful bone metastases, who wish to consider MRgHIFU treatment. These patients will be identified in conjunction with the pain and palliative care teams, as well as clinical and medical oncologists. Patients will undergo MRgHIFU treatment using scanning and treatment planning methods that have been established in the patients treated within the multi-centre study. The treatment response rate for the cohort will be recorded. Intra- and post-procedural imaging metrics will be evaluated for their ability to detect tissue changes, which may be indicative of response. Patients will be followed-up for up to 90 days after treatment, and will attend for repeat imaging and pain review at days 30, 60 and 90 after treatment. Any changes in imaging metrics will be compared between responders and non-responders.

NCT ID: NCT03463941 Not yet recruiting - Obesity Clinical Trials

Peer Support Dyads in Churches

Start date: April 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to explore how working with a partner can influence participation in a church wellness program. There are many different types of church wellness programs. Church members are more likely to participate and achieve goals in these programs when they have peer support. The researcher would like to know what African American men and women think about working with a support partner. This information will help researchers design better church wellness programs. The participants are being asked to take part in this research because the investigators believe that it is helpful to share feelings and thoughts about experiences working with a partner to achieve health goals. This knowledge will be used to create church wellness programs that will help African American men and women prevent disease and live healthier lives.

NCT ID: NCT03461939 Not yet recruiting - Cancer Clinical Trials

ePRIME: Patient-Reported AEs in Early Phase Trials

Start date: June 2018
Phase: N/A
Study type: Observational

New treatments are continually being developed to help patients living with advanced cancer, which require extensive clinical trials before authorisation for standard clinical use. Reporting of adverse events (AE) in this setting is essential to ensure treatment safety and tolerability. The current system for reporting AEs, the Common Toxicity Criteria and Adverse Events (CTCAE) relies on the clinician's interpretation of patient symptoms, but a substantial body of evidence suggests clinicians miss/underestimate AEs experienced by patients. The aim of the overall project is to explore the implementation of an electronic patient-reported outcomes (ePRO) system to gather adverse events data in early phase clinical trials (EPCT) patients. In Phase 1 of this study, through semi-structured interviews, we explored patient, healthcare, and clinical trial staffs' views about collecting electronic patient-reported outcomes in this setting. This work informed the direction of the current pilot. This proof-of-principle feasibility study will explore the feasibility and satisfaction with using an electronic system to remotely self-report AEs whilst on EPCT. The key objectives are to: 1. Evaluate the feasibility of using a secure online method (ePRIME system) to collect PRO-AEs in EPCT patients. 2. Explore patient satisfaction with the use of the ePRIME system to collect PRO AEs in EPCT patients. 3. Monitor the number of notifications for severe AEs generated by the system to address concerns from the interviews that ePROs will lead to increased workload. To this end, a prospective longitudinal pilot will be conducted of the ePRIME system in early phase clinical trial patients in Leeds and Sheffield. A convenience sample of patients enrolled in Phase I or Phase II trials will be recruited. Patients in general oncology and haematology clinics will be included if diagnosed with metastatic or progressive disease and are presently receiving novel agents in an academic early phase clinical trial, such as chemotherapy, targeted agents, or chemo-radiotherapy. Patients will be included in this pilot whether the trial is a test of a novel drug, drug combination, or dose escalation. The study will aim to identify, approach, and consent all eligible patients over a 12 month period. If they are over 18, able to give informed consent, have access to internet via any device, and able to read and understand English. Patients will be approached and consented within 1 month of having been entered in the clinical trial. Patients will not be eligible if they will be on the clinical trial for less than 3 months. Each patient will complete a patient-reported AE checklist at baseline (i.e. time of consent) and then weekly for 12 weeks. At the end of the 12 weeks an end-of-study interview will be conducted to explore patient satisfaction with the system. It is envisaged that this project will provide initial information on the feasibility and acceptability of a novel electronic system to facilitate the collection of patient-reported AEs in early phase trials.