Behavioral Intervention for Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Carcinoma+3 More
Behavioral Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma

Study Summary

This study is evaluating whether an app-based mindfulness intervention may help patients cope with their disease.

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Eligible Conditions

  • Carcinoma
  • Carcinoma, Renal Cell
  • Stage IV Renal Cell Cancer AJCC v8
  • Metastatic Renal Cell Carcinoma ( mRCC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Behavioral Intervention will improve 15 primary outcomes in patients with Carcinoma. Measurement will happen over the course of 3 months.

3 months
Brief Fatigue Inventory (BFI): Fatigue Interferance
Brief Fatigue Inventory (BFI): Fatigue severity
Fear of Cancer Recurrence-7
Feasibility metric 1
Feasibility metric 2
Feasibility metric 3
Feasibility metric 4
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Emotional
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Functional
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Overall
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Physical
Functional Assessment of Chronic Illness Therapy-General (FACT-G): Social/ Family
Mindfulness Attention Awareness Scale (MAAS)
PROMIS Emotional Distress: Anxiety
PROMIS Emotional Distress: Depression

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Device feasibility (app-based mindfulness program)

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Behavioral Intervention is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Device feasibility (app-based mindfulness program)Patients participate in a mindfulness-based program by using the Am app for 20-30 minutes every day, a minimum of 4 days each week over 4 weeks.
App-based mindfulness program
Behavioral
Patients participate in a mindfulness-based program by using the Am app for 20-30 minutes every day, a minimum of 4 days each week over 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2017
Completed Phase 4
~3170

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Sufficiently fluent in English
You have a cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC). show original
Evidence of metastatic disease (including at a minimum computed tomography [CT] of the chest, abdomen and pelvis for staging)
Undergoing immunotherapy
A "moderate" or greater fear of cancer progression, as demonstrated by an Fear of Cancer Recurrence-7 (FCR-7) score of >= 17
A fear of cancer progression, as demonstrated by a Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety score >= 13
You have a smart phone with internet access. show original
You have not participated in an MBCR or MBSR program in the past 5 years. show original
You have not engaged in meditation within the previous year. show original
You are not suffering from current major depressive disorder, bipolar disorder or other psychiatric disorder. show original

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 is carcinoma?

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In developing countries, cancer forms one of the main causes of death. It is estimated that about 1 man out of every 10 dies from cancer in the US, and every 19 in the UK. In fact, most cancer deaths occur in those who have been born in developing countries. The most common form of cancer-related death in developing countries is lung cancer. There are about 40 million new cases of cancer each year and 80 million cancer deaths in the developing world. The numbers of those dying from cancer have almost doubled worldwide during the past 50 years. In developing countries, lung cancer is the most common cancer, second only to cervical cancer.

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What are the signs of carcinoma?

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An increased number of clinical signs was observed in the carcinoma group when compared to the benign group. Thus, many physical signs and symptoms that occur in patients with carcinoma are not only indicative of carcinoma, but also of other benign diseases. Therefore, it is important to remember the signs and symptoms, because they can lead one to misdiagnoses and more invasive treatments, which in turn will increase costs and increase long-term adverse effects.

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Can carcinoma be cured?

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The findings show that with treatment, over 80% of carcinoma patients can be cured. Those who become curettage rejectors on androgen deprivation treatment can regain their erectile function to full potency within two years without further therapy.

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What causes carcinoma?

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The occurrence of carcinoma has been linked to environmental factors such as diet and physical activity. However, the exact cause of carcinoma has yet to be determined.

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

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Carcinoma of the lung is by far the most prevalent cause of cancer death. It accounts for 28,000 cases per year, or 7.2% of all cancer cases. In contrast, carcinoma of the uterine, ovary, and rectum are rarer causes of cancer death. They each account for approximately 3,000 cases per year. Carcinoma of the bladder is associated with relatively high mortality due to it being a tumor closely associated with chronic urinary tract infection. Carcinoma of the colon and rectum, as well as cancers of the breast and thyroid, are important causes of disease-related mortality in the United States.

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What are common treatments for carcinoma?

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Treatments for carcinoma of the upper aerodigestive tract include surgery, chemotherapy, radiation therapy, and targeted therapy. Of these, surgery is the major form of therapy.

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What are the chances of developing carcinoma?

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In a large sample-based cancer registry, we found that the lifetime risk of developing carcinoma in a male and in an female with SLE was approximately 3 - 5% and 7 - 13%, respectively. The prevalence of SLE was about 6% and 7% among men with and without carcinomas, respectively. The age-adjusted lifetime risk of cancer in male SLE patients was 2.4-2.7% and for female patients 8.9-10.3%.

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Is behavioral intervention typically used in combination with any other treatments?

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This preliminary research highlights an area of research that warrants further examination and supports the notion that behavioral interventions (including communication enhancement) are likely to be included in treatment plans for breast cancer and other oncology patients.

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What does behavioral intervention usually treat?

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The behavioral intervention is a safe treatment that can lead to a reduced length of stay, reduced time to recurrence, and improved quality of life in the patients with HCC.

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Who should consider clinical trials for carcinoma?

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It must be highlighted that there are certain groups, both in the United States and abroad, that would be in a position to benefit from randomized, controlled clinical trials, however, these groups will be very few and only a small proportion of all patients with carcinoma will be able to participate in these studies.

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How serious can carcinoma be?

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Cancers and their corresponding symptoms are typically fatal if left untreated. In this review, we report on the management and prognosis of various cancers which have already had an overall positive impact on human life.

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What are the latest developments in behavioral intervention for therapeutic use?

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This report provides an overview of current research and practice in the delivery of behavioral therapy interventions to cancer survivors. Findout more about this topic on [Therapeuticuseresearch.com].

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