CLINICAL TRIAL

CARE for Malignancies

Waitlist Available · 18+ · All Sexes · Boston, MA

This study is evaluating whether a psychological intervention may help improve the quality of life and mood of caregivers of patients undergoing stem cell transplant.

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About the trial for Malignancies

Treatment Groups

This trial involves 2 different treatments. CARE is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CARE
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Standard Transplant Care
OTHER
CARE
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A relative or friend who lives with the patient or who has regular contact with him or her, and is identified as the primary caregiver for the patient's transplant. show original
Adults who will be caregivers for patients undergoing either autologous or allogeneic HCT at MGH are required to attend the HCT consent visit with the patient. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CARE will improve 1 primary outcome and 5 secondary outcomes in patients with Malignancies. Measurement will happen over the course of up to day +90.

Compare caregiver mood (HADS) between the study arms
UP TO DAY +90
We will compare caregiver mood use the Hospital Anxiety and Depression Scale (HADS) at day +30 and day +90 (controlling for baseline values). The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress))
Compare Caregiver QOL (CarGOQOL) between the study arms
UP TO DAY +90
we will compare caregiver QOL as measured by CarGOQOL at day +30 and day +90 after the intervention (adjusting for baseline values)
Compare caregiving burden (CRA) between the study arms
UP TO DAY +90
we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA) at day +30 and day +90 after the intervention (adjusting for baseline values)
Compare caregiver self-efficacy (CASE-t) between the study arms
UP TO DAY +90
We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) at day +30 and day +90 (controlling for baseline values). The scale ranges from 0 to 170 with higher scores indicate higher self efficacy
Compare perceived coping skills (MOCS) between the study arms
UP TO DAY +90
Compare caregiver coping skills using the Measure of Current Status (MOCS) between the study arms. Score ranges from 0-52, with higher scores indicating higher coping skills
Feasibility of the intervention (feasibility description below)
2 YEARS
Feasibility defined if at least 60% of eligible caregivers are enrolled in the study and attend at least 50% of the intervention visits

Who is running the study

Principal Investigator
E. A.
El-Jawahri Areej,M.D., Principal Investigator
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of malignancies?

The most specific signs of malignancy are a lump, a mass, and an abnormal bleeding or bruising. Other symptoms that suggest a malignancy include a rapid progression of symptoms, being more than one year younger than the median for cancer, a family history of cancer, a first cancer before the fifth decade of life, a poor appetite, weight loss, poor bowel habits, nausea, vomiting, and night sweats.

Anonymous Patient Answer

What is malignancies?

A common cancer is skin cancer, which can be caused by environmental rays such as UV rays from the sun and by light tanning beds. Some cancer cases are caused not by environmental factors but are a reflection of a predisposition to cancer. Cancer forms in the colon, lung, breast, skin, liver, brain, thyroid gland, and stomach (the cancerous cells usually develop from tissues of the gastrointestinal tract). Some cancers have a tendency to spread to other body parts including the bones, skin, brain, lymph nodes, liver, and blood vessels. Malignant cancer, like other types, results in cell death through apoptosis and other processes.

Anonymous Patient Answer

What causes malignancies?

A number of genetic, epigenetic and other factors are believed to contribute to most malignancies. It is not unlikely that different types of cancer will result from a combination of factors or conditions. These include a genetic component, environmental conditions and infection with a virus. Clearly there is no one sole cause of any type of cancer.

Anonymous Patient Answer

Can malignancies be cured?

This review of the published literature on malignancies suggests that there is no credible evidence that malignancies--specifically non-cancerous and cancerous-- can be cured or otherwise cured with current treatments.

Anonymous Patient Answer

What is care?

Physicians are still relying on printed medical textbooks to teach a generation of doctors where and how to take care of patients. This is a dangerous approach as many physicians do not take an interest in reading medical texts or being taught how to take care of their patients.

Anonymous Patient Answer

What are common treatments for malignancies?

The treatment of patients with malignant neoplasms has increased dramatically in recent years. Patients are treated using a variety of different therapies, and treatment choices are largely influenced by the specific tumors treated.\n\nThere is a great deal of heterogeneity among the various treatments used. Most cancers are treated with multimodal therapy. Chemotherapy is used more frequently in treating cancer than any other treatment modality. New treatments, including targeted agents, surgery, and immunotherapy, are increasingly used.

Anonymous Patient Answer

How many people get malignancies a year in the United States?

The present study shows that, in most of the U.S, the cancer incidence exceeds the deaths almost fourfold, and that there are 3.3 million new cases per year. If this estimate is correct, there are 531,000 new cases of cancer per year. These values are consistent with data that show that at least two-thirds of cancer deaths are due to lung cancer and colorectal cancer, and that at least two-thirds of bladder cancers are due to tobacco-related cancer.

Anonymous Patient Answer

Have there been any new discoveries for treating malignancies?

A few new drugs for malignancies were either approved in the US or were in late-stage trials during the year 2007. The US Food and Drug Administration approved several new compounds for use in cancer treatment because they showed more promising results than those that were already approved in the United States. However, the majority of these compounds were either approved in different countries outside of the US or were awaiting approval from the US Food and Drug Administration. Another good example is the development of cetuximab. Cetuximab was approved for treating metastatic nonsmall cell lung cancer in 2002.

Anonymous Patient Answer

Is care typically used in combination with any other treatments?

A study is now warranted as to which combinations of modalities used in various patients would be most cost effective and to what extent any reduction in overall costs would be due to the use of these modalities individually.

Anonymous Patient Answer

What is the primary cause of malignancies?

[Cells acquire oncogenic (e.g., fusion oncogene) mutations early in tumorigenesis, and these defects affect most, if not all, of the normal cells, such as fibroblasts, endothelial cells and epithelial cells of the gastrointestinal tract, mammary glands and skin (Fig. 1). The acquisition of such mutations is not a prerequisite for somatic evolution in cancer cells, since almost 60% of cancers are accompanied by a loss of normal-appearing cells, termed hitchhiking. Many cancers are associated with mutations or deletions of long (over 100 kb) chromosome arms containing target tumor suppressor genes (Fig.

Anonymous Patient Answer

What are the latest developments in care for therapeutic use?

Currently no FDA-approved medications are specific for the treatment of CLL. Nevertheless, two medications, obinutuzumab and bortezomib, have undergone Phase II clinical studies. Bortezomib is well tolerated in these studies, and may provide a new way to treat CLL. Additionally, a Phase III clinical study of obinutuzumab has completed enrollment. However, a similar Phase III study comparing bortezomib to standard of care has not yet been published.

Anonymous Patient Answer

Who should consider clinical trials for malignancies?

Recent findings of this study suggest that patient groups who are currently not included in clinical trials should be considered as candidates for clinical trials in the following areas: young, elderly, and women. In addition, patients with metastatic solid tumors should consider the clinical trial option.

Anonymous Patient Answer
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