Development and Testing of a Telephone Triage Decision Support System (TTDSS) for Cancer Patients
This study aimed at testing the technical and clinical feasibility of the Mandarin Version of the electronic patient self-Reporting of Adverseev ents (eRAPID-MV) and the telephone triage decision support system (TTDSS) by testing them on patients with breast and colorectal cancer. The hypothesis of this study was the patients with breast and colorectal cancer who received eRAPID-MV and TTDSS were performing better on patient care outcomes and telephone screening service outcomes than patients who had not received eRAPID-MV and TTDSS. A non-randomized comparison trial was performed in St. Martin De Porres Hospital, Taiwan from July 2022 to April 2023. This study employed a quasi-experimental design to collect data from a treatment induced adverse events (TRAEs) questionnaire, a satisfaction questionnaire, and an interview with patients. It used the system usability scale (SUS) to assess data usability. 136 patients with breast cancer or colorectal cancer were unrolled and distributed in two groups. In Phase I, participants were selected based on convenience sampling and non-randomly assigned to an experimental group (N=68). They received chemotherapy and completed the eRAPID-MV measures-based TRAEs survey every week. The control group (N = 68) received usual care. The program duration was 24 weeks. At the end of the program, the researcher recruited participants from the experimental group based on voluntary recruitment for a single interview to assess their views on the eRAPID-MV system. The interview duration was approximately 20-30 minutes. Both groups completed the pre-test and post-test TRAEs questionnaire. In Phase II, when the TRAEs survey indicated a red light for experimental group, the eRAPID-MV system provided automatic recommendations to the patient to seek emergency medical services, or the patient contacted the case manager to deal with severe TRAEs. Simultaneously, the oncology case manager or oncologist received an alarm reminder immediately. Based on the TRAEs survey indication (red or yellow light) and consultation with the patient via a phone call, the oncology case manager reassessed the patient's TRAEs using TTDSS and scheduled their follow-up appointment accordingly. After 72 hours of intervention in Phase II (TTDSS), the first post-test was performed to assess the immediate effects. The long-term effects were evaluated at the end of the intervention, which lasted 180 days (6 months).
NCT05446051 — Treatment Side Effects
Status: Recruiting
http://inclinicaltrials.com/treatment-side-effects/NCT05446051/
Investigation of the Slimming Myokines as Biomarkers Potential for Some Gastrointestinal (GIS) and Urinarysystem (US) Cancers and on the Effects of Nutritional and Psychology of Concerned Patients
With the project investigators propose, investigators aim to find answers to the following questions: The fact that irisin and atropine are slimming the proteins that cause an increase in weight loss, and the excessive wasting (cachexia) in some types of cancer makes us wondering whether these factors may be cachectic factors for some GIS and US cancers? It is aimed to determine the relationship between irisin, atropine, some cachectic factors (PIF, ZAG), and cytokines (TNF-α, IL-1, IL-6) at tissue and plasma levels in these types of cancer. In addition, will psycho and nutrition education be applied to patients have an effect on cachexia? Experimental approaches to be used to find answers to such questions make this project unique.
NCT05278078 — Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/cancer/NCT05278078/
Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial trial is to identify components of a intervention (CASCADE) to enhance the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2x2 full factorial design, 352 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).
NCT04803604 — Cancer
Status: Recruiting
http://inclinicaltrials.com/cancer/NCT04803604/
Optimizing Neoadjuvant Systemic Treatment for Breast Cancer by Clinical Decision Support System
This study compares two approaches of upfront chemotherapy in breast cancer.
NCT04802941 — Decision Support Systems, Clinical
Status: Recruiting
http://inclinicaltrials.com/decision-support-systems-clinical/NCT04802941/
mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)
The central hypothesis is that use of mIVAA (mobile Inspección Visual con Ácido Acético - Spanish for Visual Inspection with Acetic Acid (VIA)) will increase the proportion of VIA positive women who complete follow-up clinical evaluation compared to VIA positive women in situations in which mIVAA was not used, thus potentially improving cervical cancer treatment and survival rates. The study will collect qualitative and quantitative data to examine the feasibility and preliminary impact of mIVAA on reducing attrition for follow-up clinical evaluations.
NCT04421131 — Cervical Cancer
Status: Completed
http://inclinicaltrials.com/cervical-cancer/NCT04421131/
Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
The purpose of this study is to evaluate the efficacy of the standardized care pathway which provides enhanced supportive care for patients with advanced cancer. A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of applying standardized care pathway to provide enhanced supportive care. A Randomized Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to intervention arm (receiving enhanced supportive care according to the standardized care pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the intervention arm will receive enhanced supportive care consisted of symptom management and coping enhancement counseling for 5 times. Data from advanced cancer patients will be collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm), at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as advanced cancer patients' symptom, coping and quality of life.
NCT04407013 — Advanced Cancer
Status: Recruiting
http://inclinicaltrials.com/advanced-cancer/NCT04407013/
Clinical Application of Preoperative Nutritional Support Package for Liver Cancer
Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection. Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.
NCT04218253 — Liver Neoplasms
Status: Recruiting
http://inclinicaltrials.com/liver-neoplasms/NCT04218253/
Supportive and Survivorship Care Program for Cancer Patients: a Cluster Randomized Controlled Pilot Study Among Breast and Gynaecological Cancer Patients
In Singapore, cancer patients are not consistently assessed for unmet survivorship care needs and systematically identified for subsequent referral to useful care services. To address this gap, a preliminary multidisciplinary program is developed to (i) routinely screen and identify cancer patients with high distress levels, and (ii) provide appropriate care referrals after a systematic review by a supportive care nurse. This study hypothesized that breast and gynecological cancer patients receiving timely screening for distress and appropriate supportive care services will report better improvement in quality of life as compared to non-recipients under usual care. This pilot study then aims to evaluate: (i) The effectiveness of the program on a patient level in improving the quality of life and the symptom burden of patients requiring further supportive services. (ii) The feasibility of the program's implementation on a health-system level among breast and gynaecological cancer patients in the outpatient oncology clinics at a specialty cancer centre.
NCT04014309 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT04014309/
Telephone Support for Advanced Gastrointestinal Cancer Patients and Their Family Caregivers
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, spirituality), and engaging in activities consistent with these values. A total of 40 patient-caregiver dyads were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.
NCT04010227 — Gastrointestinal Neoplasms
Status: Completed
http://inclinicaltrials.com/gastrointestinal-neoplasms/NCT04010227/
Telephone Support for Metastatic Breast Cancer Patients
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in metastatic breast cancer (MBC) cancer patients. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, work), and engaging in activities consistent with these values. A total of 250 patients will be randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Patients in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. A demonstration of ACT's efficacy will lead to dissemination of the intervention and ultimately fulfill an unmet need in the comprehensive care of MBC patients.
NCT03998618 — Metastatic Breast Cancer
Status: Completed
http://inclinicaltrials.com/metastatic-breast-cancer/NCT03998618/