Quality of Life Interventions for Colon Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Hawaii
Disqualifiers: Over 60 days post-surgery
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial provides colon cancer patients and their caregivers with tablets containing helpful information about the disease and its treatment. Regular support and surveys aim to reduce anxiety, improve communication with doctors, and enhance overall care.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. It seems to focus on providing information and support rather than altering your treatment plan.
What data supports the effectiveness of the treatment Quality of Life Supportive Resources, Supportive Care, Palliative Care, Psychosocial Support, Quality of Life Ted Talks for improving quality of life in colon cancer patients?
Research shows that psychosocial interventions can improve the quality of life for colorectal cancer patients, and supportive care interventions have been linked to better overall well-being. Additionally, palliative care has been shown to help manage symptoms and improve quality of life in advanced cancer patients.
12345Is the Quality of Life Interventions for Colon Cancer treatment safe for humans?
Research on supportive care interventions, such as psychosocial support and decision aids, shows they are generally safe for cancer patients, providing emotional support and helpful information without causing distress.
678910How does the treatment for improving quality of life in colon cancer patients differ from other treatments?
This treatment focuses on psychosocial interventions, which aim to improve the quality of life for colon cancer patients by addressing emotional and social needs, unlike traditional treatments that primarily target the physical aspects of the disease.
15111213Eligibility Criteria
This trial is for adult colon cancer patients and their caregivers in Honolulu County. Patients must be newly diagnosed with stage II-III colon cancer, within 60 days post-surgery, and able to understand and write English. Caregivers can be family or someone the patient identifies as a caregiver.Inclusion Criteria
I am a caregiver living in Honolulu, over 18, speak and write English, and can consent.
Patient: Colon Cancer patients must live in Honolulu County and must identify a patient caregiver. Patients must have newly diagnosed stage II-III colon cancer and be < 60 days from surgical treatment at the time of registration. Adults over age 18. Adequate understanding of English language and must be able to read and write English. Must be able to provide informed consent.
Exclusion Criteria
I had surgery less than 60 days ago.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants and caregivers receive educational materials and support resources via computer tablets to improve quality of life and care coordination.
12 weeks
Weekly check-ins (virtual)
Follow-up
Participants are monitored for changes in quality of life and care coordination perceptions after the intervention.
4 weeks
Participant Groups
The study provides educational resources about colon cancer via tablets to improve quality of life for patients and caregivers. It includes weekly check-ins from the study team, use of information provided on tablets, and completing surveys assessing its impact.
2Treatment groups
Experimental Treatment
Group I: Group AExperimental Treatment1 Intervention
Ted Talks/Educational videos
Group II: Group 1Experimental Treatment1 Intervention
Supportive Care Materials and Resources
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hawaii Cancer Care IncHonolulu, HI
Adventist Health CastleKailua, HI
Hawaii Pacific HealthHonolulu, HI
The Queens Medical CenterHonolulu, HI
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Who Is Running the Clinical Trial?
University of HawaiiLead Sponsor
Alliance for Clinical Trials in OncologyCollaborator
References
An integrated psychological strategy for advanced colorectal cancer patients. [2019]There is evidence regarding the usefulness of psychosocial intervention to improve health related quality of life (HRQOL) in adult cancer patients. The aim of this report is to describe an integrated approach and to evaluate its feasibility in routine clinical practice in 98 advanced colorectal cancer (ACC) patients during chronomodulated chemotherapy.
The role of supportive care in quality of life. [2019]Supportive care interventions are usually given with the intent of improving quality of life. Until recently, however, even studies of palliative interventions have infrequently incorporated some measure of overall benefit. This article reviews those recent supportive care studies that have attempted to measure either quality of life or some benefit other than improvement in a single symptom. Some palliative chemotherapy studies did indeed demonstrate measurable improvement in overall well-being, and some commonly cited supportive approaches were associated with a significant detriment in health-related quality of life.
[Quality of life at the end of life. Analysis of the quality of life of oncologic patients treated with palliative care. Results of a multicenter observational study (staging)]. [2022]Outcome in palliative care can be defined as patients' quality of life, quality of death and satisfaction with care. In an Italian multicentre prospectic study ('Staging') the quality of life of 571 palliative care patients with advanced cancer disease was assessed since the beginning of palliative care till the end of the study. We analyzed the tissue of quality of life missing data and the possibility to input the missing quality of life evaluation through the quality of life evaluation made by a proxy (doctor, nurse). The greatest functional impairment and an increasing level of some symptoms (fatigue, general malaise, emotional status) were observed during the last two weeks of life, whereas for other symptoms (gastro-intestinal, pain) some degree of control was possible. The quality of life analysis for palliative care patients should consider the different response of different quality of life components to the palliative care intervention.
Surgical perspectives in gastrointestinal disease: a study of quality of life outcomes in esophageal, pancreatic, colon, and rectal cancers. [2019]Outcomes assessment in surgery traditionally has included data regarding peri-operative mortality and morbidity, as well as long-term survival and recurrence in surgical oncology. However, quality of life (QOL) is another important patient-related outcome measure. QOL data can be used to tailor treatment and improve clinical outcomes by detecting physical or psychological problems in patients that otherwise might be overlooked, but which have profound implications for the effective delivery of care. We review several well-validated QOL instruments developed specifically for use in patients with gastrointestinal malignancies, including esophageal, pancreatic and colorectal cancers, and conclude that QOL assessment routinely should be included in clinical trials of novel treatments.
A systematic review of psychosocial interventions for colorectal cancer patients. [2018]A significant minority of colorectal cancer (CRC) patients experience clinically meaningful distress that may warrant intervention. The goal of this systematic review was to assess the impact of psychosocial interventions on quality-of-life and psychosocial outcomes for CRC patients.
Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN). [2019]Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare.
Supportive telephone intervention for patients receiving chemotherapy. A pilot study. [2004]Psychosocial interventions have been shown to improve quality of life (QOL) for many cancer patients. A pilot study was conducted to assess the feasibility of a psychoeducational intervention for cancer patients receiving chemotherapy. Eight patients receiving chemotherapy for colorectal carcinoma participated. The intervention is based on a modification of Interpersonal Therapy. It consisted of four sessions, administered biweekly, using a manual format, by a psychiatric nurse clinician over the telephone. The participants also completed a set of QOL measures by telephone to assess tolerance of the planned assessment. The patients received assistance with treatment-related side effects, reported improved ability to communicate with their physician, and gained an understanding of the stresses they discussed. The patients felt satisfied with the emotional support and medical information provided. A randomized trial is planned to test the intervention for patients participating in a cooperative trial sponsored by the National Cancer Institute.
An Observational Study of Team Management Approach for CapeOX Therapy in Patients with Advanced and Recurrent Colorectal Cancer: SMILE Study (The Study of Metastatic colorectal cancer to investigate the Impact of Learning Effect). [2022]In recent years, CapeOX therapy for patients with colorectal cancer is widely used. We previously reported that a multidisciplinary approach decreases the worsening of adverse events and increases patient satisfaction. In this study, we conducted a multicenter, prospective, observational study to evaluate the incidence of adverse events, health-related quality of life (HRQOL) of the patient, and efficacy of a management (intervention) according to the support system (SMILE study).
A pilot trial of decision aids to give truthful prognostic and treatment information to chemotherapy patients with advanced cancer. [2023]Most cancer patients do not have an explicit discussion about prognosis and treatment despite documented adverse outcomes. Few decision aids have been developed to assist the difficult discussions of palliative management. We developed decision aids for people with advanced in curable breast, colorectal, lung, and hormone-refractory prostate cancers facing first-, second-, third-, and fourth-line chemotherapy. We recruited patients from our urban oncology clinic after gaining the permission of their treating oncologist. We measured knowledge of curability and treatment benefit before and after the intervention. Twenty-six of 27 (96%) patients completed the aids, with ameanage of 63, 56% female, 56% married, 56% African American, and 67% with a high school education or more. Most patients (14/27, 52%) thought a person with their advanced cancer could be cured, which was reduced (to 8/26, 31%, P = 0.15) after the decision aid. Nearly all overestimated the effect of palliative chemotherapy. No distress was noted, and hope did not change. The majority (20/27, 74%) found the information helpful to them, and almost all (25/27, 93%) wanted to share the information with their family and physicians. It is possible to give incurable patients their prognosis, treatment options, and options for improving end-of-life care without causing distress or lack of hope. Almost all find the information helpful and want to share it with doctors and family. Research is needed to test the findings in a larger sample and measure the outcomes of truthful information on quality of life, quality of care, and costs.
Explaining marginal benefits to patients, when "marginal" means additional but not necessarily small. [2010]Patients and their families want us to be realistic, honest, and caring about their prognosis and their options, even when the news is bad. Most oncologists will tell a patient if he is not curable, but not give specific survival information unless prompted. As an example, chemotherapy for pancreas cancer improves survival and does not worsen quality of life, but the impact on lifespan is small. Patients with advanced pancreas cancer have options that increase their average survival by about 16/100 at 1 year, and by about 9 weeks compared with best supportive care, but almost all patients are dead by 24 months. As an example of "marginal benefit" ("marginal" is defined here as more than that offered by the alternative care, not necessarily small or worthless), erlotinib added to gemcitabine compared with gemcitabine alone improves survival by six additional people at 1 year, and an average of 2 weeks, with no survival tail. In addition, the additional drug cost alone can be more than $12,000 a month. We use this clinical practice as a way to describe marginal benefit to patients. Telling patients that they have incurable disease and that treatment is ineffective is hard. Partly as a result, only about a third of cancer patients are told they are going to die, and those who are not told live no longer but have worse medical outcomes, such as dying on a ventilator and less time with hospice. These difficult conversations can be done if the oncologist has the right medical information, the right script, and some decision aids.
The psychiatrist's perspective on quality of life and quality of care in oncology: concepts, symptom management, communication issues. [2019]The important prevalence of psychosocial problems and psychiatric disturbances that have been reported in oncology, underlines the need for comprehensive psychosocial support for cancer patients and their families. Psychosocial support is designed to preserve, restore or enhance quality of life. Quality of life refers not only to psychosocial distress and adjustment-related problems but also to the management of cancer symptoms and treatment side-effects. Psychosocial interventions designed for this purpose should be divided into five categories: prevention, early detection, restoration, support and palliation. Firstly, preventive interventions are designed to avoid the development of predictable morbidity secondary to treatment and/or disease. Secondly, early detection of patients' needs or problems refers to the assumption that early interventions' could have therapeutic results superior to those of delayed support, both for quality of life and survival. Thirdly, restorative interventions refer to actions used when a cure is likely, the aim being the control or elimination of residual cancer disability. Fourthly, supportive rehabilitation is planned to lessen disability related to chronic disease, characterised by cancer illness remission and progression, and to active treatment. Fifthly, palliation is required when curative treatments are likely to no longer be effective, and when maintaining or improving comfort becomes the main goal. Psychological interventions are often multidisciplinary, with a variety of content. The type of psychological intervention ranges from information and education to more sophisticated support programmes including directive (behavioural or cognitive) therapies, or non-directive (dynamic or supportive) therapies. Social interventions usually include financial, household, equipment, and transport assistance depending on individual and family needs and resources. These interventions may be combined with the prescription of pharmacological (psychotropic, analgesic), physical, speech or occupational therapies, especially in rehabilitation programmes. Health care services devoted to delivery of these interventions are hospital, hospice or home-based and organised very differently depending on already available community resources and local practice.
A systematic review of psychosocial interventions to improve quality of life of people with cancer and their family caregivers. [2021]To review the characteristics and effectiveness of psychosocial interventions on quality of life of adult people with cancer and their family caregivers.
Psychosocial Interventions for Patients With Advanced Cancer and Their Families. [2020]Few randomized controlled trials of family-based psychosocial interventions involving patients and at least one other family member have been conducted in the context of advanced cancer. Moreover, existing interventions have largely been stand-alone programs that have not been well integrated into routine palliative and clinical care. Programs that address this gap may not only improve patient and caregiver quality of life (QOL) but also the quality of palliative and supportive care services. The aim of this narrative review is to describe published interventions that have attempted to improve the QOL of advanced cancer patients and their family caregivers (eg, spouses, partners, and other family members) and to describe some of the challenges that make it difficult to implement such programs in clinical settings. Toward that end, the added value that family-based psychosocial interventions can bring to advanced cancer care is first described. Next, the literature on family-based interventions in advanced cancer is reviewed, and different theoretical approaches and outcomes are highlighted. This is followed by a description of some of the health system barriers to supportive family care in advanced cancer care. The article concludes with a synthesis of research findings and proposes directions for future research.