A Randomized Clincial Trial to Evaluate the Effects of an Internett-based Support System for Cancer Patients on Symptom Distress, Depression, and Quality of Life.
Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. The system allows patients to monitor symptoms over time, and provides access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients can ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients. This randomized clinical trial: 1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life, depression and health service use, and secondary outcomes of self-efficacy, social support . We will also analyze: 2. Relationships between primary and secondary outcomes; 3. How patients' symptom distress varies over time; 4. Patients' preferences for participation in decision making about symptom management 5. How patients use WebChoice, such as frequency of use, duration, most used components; 6. How patients' experience WebChoice's usefulness and ease of use; 7. Patterns and content of patients' communication with the cancer nurse and other patients. 325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from throughout Norway through advertisements and invitation letters and the Norwegian Cancer Registry. Patients were randomly assigned to WebChoice or the control group that received usual care. Patients are being followed with 5 repeated measures over 12 months. Data are being collected through questionnaires, from system logs, and from interviews that were conducted in subset of experimental group patients. The primary hypothesis will be tested with Repeated Measures ANCOVA techniques. The other research questions will be answered using various inferential and descriptive techniques and through content analysis of messages and transcripts of patient interviews. This study can make a significant contribution to reduce unnecessary suffering and improve the quality of life for a large group of cancer patients.
NCT00710658 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00710658/
Psychosocial Support for Cancer Patients
This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing 120 patients per site (120x3). The purpose of this study is to compare two types of counseling for cancer patients: "Dignity Psychotherapy" and "Supportive Psychotherapy" as well as "Standard Palliative Care." Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. We, the investigators at Memorial Sloan-Kettering Cancer Center, have developed a type of counseling we call "Dignity Psychotherapy." It is intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall quality of life, despite having cancer. "Supportive Psychotherapy" is another type of counseling intended to help patients feel more at ease and express and reflect on any feelings or concerns they might have about their illness. Both of these types of counseling will be compared to "Standard Palliative Care." We will look at how these types of treatments affect patients' mood, outlook, and quality of life. We also want to see how the type of treatment they receive affects their family members and significant others.
NCT00133965 — Cancer
Status: Completed
http://inclinicaltrials.com/cancer/NCT00133965/
Prospective Epidemiological Study to Expand Knowledge on Efficacy and Safety of a Routine Post-operative Supportive Therapy With the Mistletoe Extract Iscador® Qu Within Oncological Treatment of Colorectal Cancer Stages UICC II-IV
Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with colorectal cancer (Union for International Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only. Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 5 years. Prospective observational confirmation study of previous retrospective cohort study. As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.
NCT01448655 — Colorectal Cancer
Status: Recruiting
http://inclinicaltrials.com/colorectal-cancer/NCT01448655/
Evaluating the Implementation of Head and Neck Cancer E-health Study (ENHANCE): A Hybrid Type 2 Implementation-effectiveness Study to Evaluate a Cancer Support App in Patients With Head and Neck Cancer
The NHS Long Term Plan has an ambition to provide patients with digital services and tools to give them more control over their own health and care. Guy's Cancer Centre in London (UK) is offering patients with head and neck cancer (HNC) the use of a smartphone cancer support app. Few studies have evaluated the best way to implement apps to support patients with cancer, nor explored how they could help patients to self-manage. This is a hybrid implementation-effectiveness study to evaluate the implementation of a cancer-specific self-management app currently being used at Guy's Cancer Centre. The purpose of the study is to assess the following: (1) key implementation outcomes, including acceptability and usability; (2) barriers and facilitators to patients and staff using the app; (3) the effectiveness of the app to support patients to self-manage during treatment for HNC. Eligible participants include patients being treated for HNC, and their oncology clinical team. The study will be conducted at Guy's Cancer Centre, a comprehensive cancer centre in London, UK. The study will employ mixed methods. Data collection will involve questionnaires to measure the acceptability and usability of the app, and routinely collected patient-reported outcome measures. In addition, a sub-sample of participants will take part in semi-structured interviews to explore how the app was used and views about the implementation process. Findings from this study will identify barriers and facilitators to using the app and context about how it may help patients to self-manage their condition. These findings will help to refine ongoing development of digital cancer services. Findings will inform the development of recommendations for the integration of digital health in cancer services that can be shared with Cancer Alliances across the UK.
NCT05785247 — Head and Neck Neoplasms
Status: Recruiting
http://inclinicaltrials.com/head-and-neck-neoplasms/NCT05785247/
Develop and Test the Effects of the 'Computer-Assisted OPD Personalized Supportive Cancer Care Program (COPSCCP)' on Early Stage Lung Cancer Patients
Although there is a relatively better prognosis, the 5-year survival rate for early stage lung cancer (Stage I, II, IIIA) is still relatively low compared to those other types of cancer. These patients might suffer lots from the uncertainty and substantial disease and treatment related physical changes. The investigator aims to (1) Develop and construct the contents, related patient education materials and computerized systems of the three evidence and service-based lung cancer care programs, including (a) Control as usual care (UC+ case manager care, or Control group), and (b) Computer Assisted OPD Personalized Supportive Care Program (UC+COPSCCP or Ex group); and (2) Compare the effects of Ex and care as usual (receiving usual care and case manager care) on self-report quality of life (QOL), physical symptoms, physical function and fear of cancer recurrence (FCR) in newly diagnosed early-stage lung cancer patients. Eligible patients will be newly diagnosed early stage lung cancer patients (patients in stage I, II, & IIIA) who have received surgery. A 2-group randomized control trial (RCT) matching with cancer stages will be conducted. For the COPSCCP, patients will be intervened for 6 months from the first time during hospitalization of receiving surgery or before hospital discharge and then OPD intervention. Each patient will be followed 6 time points for 2 years (will be drop and refer to medical oncology while having recurrence, metastasis or death): baseline (pre-discharge from hospital) and 1, 3, 6, 12, and 24 months after discharge from hospital, T1-T6, respectively. The outcomes indicators will include: psychological variables, physical/disease variables, symptoms, lung function, and recurrence rate during 2 years. The estimated subjects would be 150 for each group, totally 300 subjects recruited in the beginning of the study. Results would be analyzed mainly by GEE and survival analysis. IRB approval will be received before the RCT. The investigator expects to develop and test the supportive cancer care interventions and generalize the interventions into the cancer care system after the study if prove good outcomes.
NCT04506359 — Lung Cancer
Status: Recruiting
http://inclinicaltrials.com/lung-cancer/NCT04506359/
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
The goal of this research study is to conduct an open pilot of a behavioral change intervention called PROstate Cancer Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior change tools and to increase exercise, reduce side effects of androgen deprivation therapy (ADT), and improve quality of life in Black and Hispanic/Latino men with prostate cancer. The name of the intervention used in this research study is: PROWESS (behavioral change intervention)
NCT05755490 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05755490/
Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated: Randomized, Comparative, Prospective Multi-Centre Study
The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of isolation, treated for locally advanced or metastatic cancer.
NCT02829762 — Elderly
Status: Recruiting
http://inclinicaltrials.com/elderly/NCT02829762/
Assessment of Quality of Life and Independence, as Well as Received Social Support in Patients Before and After Surgery for Spinal Cancer
- Evaluation of the quality of life of patients before and after surgery for benign and malignant spinal cancers, assessing whether it depends on the size of the tumor, type of cancer, malignancy and its location - evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, evaluation of what factors influenced patients' different independence - multidimensional assessment of perceived social support of patients before and after surgery for benign and malignant spinal cancers, taking into account three sources of support: significant person, family and friends
NCT06395831 — Spinal Canal Tumors
Status: Recruiting
http://inclinicaltrials.com/spinal-canal-tumors/NCT06395831/
Evaluation of the Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity
Adapted physical activity session with a formed professional is proposed in standard care since 2022 in the immuno-hematological service to all children with newly diagnosed cancer or relapse. The aim of this study is to keep the children in the APA programm during all the treatment lenght. This study aims to evaluate by questionnaires the motivation keys and restraint from children and parents before the APA program starts (at diagnosis or relapse if not previously participating to an APA programm) and after 4 to 6 months of APA programm. The final expected fallout is to enhance children adhesion to long term APA program by implementing tools in current practice to overcome restraints from young patients and their parents
NCT06230016 — Childhood Cancer
Status: Recruiting
http://inclinicaltrials.com/childhood-cancer/NCT06230016/
Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment
NCT06015971 — Sarcopenia
Status: Recruiting
http://inclinicaltrials.com/sarcopenia/NCT06015971/