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15 studies found for:    patient-reported outcomes (PRO) cancer | lymphoma
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Rank Status Study
1 Completed Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
Intervention:
Phase:
Study Design: Time Perspective: Prospective
Outcome Measures: Evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system;   Evaluate patients understanding of the PROCTCAE item language
Number Enrolled: 1499
Study Start: November 18, 2009
2 Completed Testing a Spanish Version of a Patient Toxicity Questionnaire
Intervention:
Phase:
Study Design: Time Perspective: Prospective
Outcome Measure: Perceptions of the clarity and ease of response to a series of questions
Number Enrolled: 120
Study Start: January 2, 2012
3 Recruiting Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
Interventions: Behavioral: surveys;   Other: Blood draw;   Device: Transvaginal ultrasounds
Phase:
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Outcome Measures: determine the natural history of sexual and reproductive health;   predictors of sexual dysfunction during and after treatment;   impact of treatment on self-reported future pregnancy/reproductive health;   factors that influence decisions regarding fertility preservation;   comparison of sexual function between breast cancer and lymphoma patients
Number Enrolled: 400
Study Start: February 2013
4 Recruiting Biobehavioral Intervention to Enhance Hematopoietic Stem Cell Transplant Recovery
Intervention: Behavioral: Behavioral techniques
Phase:
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Outcome Measures: Ability to recruit patients;   Ability to retain participants;   Ability to collect complete data from participants;   Participant willingness to be randomized and acceptability of the usual care condition;   Satisfaction with and acceptability of the behavioral techniques;   Acceptability of the assessment strategy;   Validity of the assessment strategy;   NIH Patient Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance;   NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue;   NIH Patient Reported Outcomes Measurement Information System (PROMIS) Depression;   Actigraphy indices
Number Enrolled: 48
Study Start: October 2016
5 Completed
Has Results
An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Intervention: Drug: PF-02341066
Phase: Phase 2
Study Design: Allocation: Non-Randomized;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Objective Response Rate;   Percentage of Participants With Adverse Events;   Duration of Response (DR);   Time to Tumor Response (TTR);   Disease Control Rate (DCR);   Progression Free Survival (PFS);   Overall Survival (OS);   Probability of Survival;   Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182;   Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population);   Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population);   QTc Prolongation in Participants;   Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.;   Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores;   Mean Change From Baseline of QLQ-LC13 Scale Scores;   Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK);   Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale
Number Enrolled: 1069
Study Start: January 2010
6 Recruiting Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma (NHL) Unresponsive to Rituximab or a Rituximab-Containing Regimen
Interventions: Drug: Ofatumumab and Bendamustine infusions (Arm A);   Drug: Bendamustine infusion (Arm B)
Phase: Phase 3
Study Design: Allocation: Randomized;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Progression-free-survival following ofatumumab and bendamustine combination therapy;   Clinical benefit, changes in patient reported outcome measures, and pharmacokinetics following ofatumumab and bendamustine combination therapy;   Overall response rate, overall survival, time to and duration of response following ofatumumab and bendamustine combination therapy;   Safety and tolerability of ofatumumab and bendamustine combination therapy
Number Enrolled: 346
Study Start: August 2010
7 Active, not recruiting A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Interventions: Drug: RO5072759;   Drug: chemotherapy;   Drug: rituximab [MabThera/Rituxan]
Phase: Phase 3
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma;   Progression-free survival in the overall study population, investigator-assessed;   Progression-free survival, Independent Review Committee - assessed;   Response (overall response and complete response), investigator-assessed;   Response (overall response and complete response), Independent Review Committee - assessed;   Overall survival;   Event-free survival;   Disease-free survival;   Duration of response;   Time to next anti-lymphoma treatment;   Safety: Incidence of adverse events;   Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire);   Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures)
Number Enrolled: 1401
Study Start: July 2011
8 Active, not recruiting Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy
Interventions: Drug: Doxepin Hydrochloride;   Other: Placebo;   Other: Quality-of-Life Assessment;   Other: Questionnaire Administration
Phase:
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Outcome Measures: Change in mouth pain using a 0 to 10 numerical analogue scale for mouth pain;   Adverse event rates using CTCAE, RTOG and PRO;   Change in mouth pain using crossover analysis;   Incidence of drowsiness;   Incidence of grade 3 or higher adverse events as measured by CTCAE and RTOG adverse event grade scales, and patient-reported outcomes (PRO);   Incidence of stinging or burning;   Incidence of unpleasant taste;   Maximum reported CTCAE grade;   Use of alternative analgesics
Number Enrolled: 50
Study Start: April 2014
9 Completed Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Intervention: Drug: Panobinostat
Phases: Phase 2 / Phase 3
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Response rate assessed by: visceral disease, lymph nodes, blood,samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease;   Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA);   Responses in index lesions assessed by lesion measurements with photographic supporting documentation;   Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes;   Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation;   Pharmacokinetic (PK) profile of LBH589
Number Enrolled: 139
Study Start: January 2007
10 Not yet recruiting Negative Pressure Wound Therapy in Groin Dissection
Intervention: Device: PICO™
Phase:
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Time to wound healing;   Wound infection As defined by Comprehensive Complication Index (CCI);   Lymphoedema (Limb volume measurements);   Need for further surgical interventions to achieve wound healing;   Scar appearance (POSAS);   Patient reported outcomes (qualitative interview)
Number Enrolled: 22
Study Start: July 2015
11 Withdrawn R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL
Interventions: Drug: R-CHOP;   Radiation: Radiotherapy
Phase: Phase 3
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: To compare 3-year event-free survival;   To evaluate and compare OS between the two arms;   To evaluate and compare the ORR and CR rate;   To evaluate and compare disease-free survival (DFS);   To evaluate treatment-failure pattern;   Number of Participants with Adverse Events in each arm;   To assess patient-reported outcomes (PROs) in both arms;   A role of interim PET after 3 cycles of R-CHOP chemotherapy: correlation with PFS and OS
Number Enrolled: 0
Study Start:
12 Active, not recruiting A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Interventions: Drug: Ibrutinib;   Drug: Bendamustine hydrochloride;   Drug: Rituximab;   Drug: Placebo
Phase: Phase 3
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Outcome Measures: Progression-free survival;   Number of participants with adverse events;   Overall response rate;   Overall survival;   Rate of minimal residual disease (MRD)-negative remissions;   Number of participants with improvement in hematologic values;   Number of participants with improvement in disease-related symptoms;   Number of participants with improvement in patient-reported outcome scores;   Plasma concentrations of ibrutinib;   Plasma concentrations of bendamustine;   Plasma concentrations of rituximab;   Number of participants with biomarkers related to B-cell receptors
Number Enrolled: 580
Study Start: September 2012
13 Active, not recruiting Determine Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell ALL
Intervention: Genetic: Single dose of CTL019
Phase: Phase 2
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Overall remission rate (ORR) = CR + CRi;   Percentage of patients who achieve best overall response (BOR) or CR or CRi with an MRD negative bone marrow by central analysis using qPCR;   Percentage of patients who achieve CR or CRi at month 6 without SCT between CTL019 infusion and Month 6 response assessment.;   Duration of remission (DOR);   Percentage of patients who achieve CR or CRi with minimal residual disease negative bone marrow;   Relapse-free survival;   Event-free survival;   Overall survival;   Response at Day 28 +/- 4 days;   Impact of baseline tumor burden on response;   Percentage of patient who achieve CR or CRi and then proceed to SCT while in remission before Month 6 response assessment;   Quality of response using MRD disease assessments before treatment at day 28 +/-4 days after treatment using central assessments by qPCR and before SCT by local assessment (flow or PCR);   Safety of CTL019 therapy;   Characterize in vivo cellular PK profile of CTL019 cells in target tissues;   Prevalence and incidence of immunogenicity to CTL019;   Effects of CTL019 therapy on Patient Reported Outcomes;   Derivation of a score to predict cytokine release syndrome;   Describe the profile of soluable immune factors that may be key to cytokine release syndrome;   Describe levels of B and T cells (blood and bone marrow) prior to and following CTL019 infusion for safety monitoring
Number Enrolled: 72
Study Start: April 2015
14 Recruiting Study to Evaluate Efficacy and Safety of MOR208 With Idelalisib in R/R CLL/SLL Patients Pretreated With BTKi (COSMOS)
Interventions: Biological: MOR00208;   Drug: idelalisib
Phase: Phase 2
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Outcome Measures: Overall response rate (ORR);   Progression-free survival (PFS);   Overall survival (OS);   Time to progression (TTP);   Time to treatment failure (TTF);   Time to response (TTR);   Duration of response (DOR);   Lymph node response (LR);   Incidence and severity of adverse events (AEs);   Anti-MOR00208 antibody formation;   Maximum Plasma Concentration (Cmax) of MOR00208;   Patient-reported outcomes on the QLQ-C30 questionnaire
Number Enrolled: 120
Study Start: November 2016
15 Active, not recruiting Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter's Syndrome
Intervention: Drug: Ofatumumab
Phase: Phase 2
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Outcome Measures: Objective response;   Overall survival;   Progression free survival;   Duration of response;   Time to next DLBCL therapy;   Reduction in Tumour Size;   Patient reported outcomes;   Safety
Number Enrolled: 35
Study Start: April 2011

Study has passed its completion date and status has not been verified in more than two years.