Behavioral Intervention for Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
Heartland NCORP, Decatur, IL
Cancer+2 More
Behavioral Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a specific type of behavioral therapy or a different type of behavioral therapy is more effective for reducing insomnia in individuals with cancer.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Malignant Solid Neoplasms
  • Hematopoietic and Lymphoid Cell Neoplasm

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Behavioral Intervention will improve 1 primary outcome and 1 secondary outcome in patients with Cancer. Measurement will happen over the course of Baseline to day 42.

Baseline to day 42
Mean change in Sleep Efficiency assessed via Actigraphy
Mean change in the Insomnia Severity Index (ISI) total score

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Group II (HEAL)
Group I (BBT-CI)

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Behavioral Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Group I (BBT-CI)Patients complete face to face/video sessions with a trained staff member over 60 minutes each on day 0 and day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks). Patients also complete phone sessions over 15 minutes each on day 7, day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks), and days 28 and 35.
Group II (HEAL)Patients complete face to face/video sessions with a trained staff member over 60 minutes each on day 0 and day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks). Patients also complete phone sessions over 15 minutes each on day 7, day 14 (if patient's chemotherapy cycles are separated by 1 or 2 weeks) or day 21 (if patient's chemotherapy cycles are separated by 3 weeks), and days 28 and 35.
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: baseline to day 42
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to day 42 for reporting.

Who is running the study

Principal Investigator
K. M.
Prof. Karen Mustian, Professor
University of Rochester NCORP Research Base

Closest Location

Heartland NCORP - Decatur, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Report problems sleeping that affect your day-to-day activities on the Insomnia Severity Index. show original
You have cancer that is in an early stage, a middle stage, or a more advanced stage. show original
Currently receiving any form of chemotherapy that kills cells, either alone or in combination with other treatments such as biologics and/or antibodies. show original
The person has a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale. show original
Be able to speak, understand and read English to participate in the study assessments and interventions

Patient Q&A Section

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

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

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Approximately 3.2 million persons are expected to be diagnosed with a cancer death each year in America. This represents almost half of all new cancer deaths. More people are likely to develop cancer before death than after death. The median age at diagnosis is 72 yr. There was almost no difference in the age-adjusted incidence rate for blacks and whites in this study. Nearly 16,000 new cases of cancer will be seen in men. About half of these will end in death in the next 10 yr. Cancer can cause a significant percentage of deaths among Hispanic and Asian Americans. The age-adjusted incidence of lung cancer and colon cancer are high among women and Asians.

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What are the signs of cancer?

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Cancer can be difficult to detect until the cancer has spread outside the normal bounds into the surrounding lymph nodes, or through the lymphatic circulation or by hematogenous spread (through the blood) to distant organs. The symptoms that people describe are not always sufficient for medical evaluation to diagnose the cancer. The clinician must first do a physical examination, then a biopsy to make a final diagnosis, and then, whenever possible, treatment in specialist centres.

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What are common treatments for cancer?

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Recent findings, patients had most often undergone cancer treatment for non-muscle-invasive cancer and were most often treated for metastatic disease. This indicates that clinicians may not be well versed on treatment options for their cancer patients. For example, patients who had noncancer-related death or serious illness may be not be receiving active cancer treatment. Also, some patients may be receiving active cancer therapy but may not receive active treatment for their noncancer-related death or serious illness.

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Can cancer be cured?

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The notion of "cure" may be difficult to explain to laypersons. The ambiguity of the term, as the possibility of a full remission of disease, is confusing to the public. The lack of clarity and consensus on this issue is troubling as it impedes meaningful patient-centered discussion and decision-making. It was my task, together with other specialists, to form an expert committee made up of specialists in different fields, to work out and endorse a clear communication structure: A concise, unambiguous description of the options, of cancer in its different stages and its various treatment options (active, palliative, and complementary), with a concise discussion of the pros and cons of each option.

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What is cancer?

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Cancer is a disease that forms when cells grow out of control and become abnormal and malignant. It is often found in the lung, liver, stomach, colon, rectum, pancreas, prostate, breast, skin, brain or lymph nodes. There are many subtypes, but only six are prevalent within the Western world, namely, [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer), breast cancer, colon cancer, cervical cancer, prostate cancer and melanoma. The other cancers have a lower worldwide incidence compared to lung cancer where it can be over 12% of all cancers.

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What causes cancer?

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The exact cause of cancer is unknown, but it is often linked to an increase in exposure to toxins, a lack of exercise, and an unhealthy diet. All of these factors can present in the womb or early development.\n

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What is the primary cause of cancer?

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There is no single overriding cause for cancer — it is a collection of multiple environmental and genetic factors. The strongest environmental factor is radiation and other types of toxins. Genetic factors are also a part of cancer formation; however, they are not the top cause for cancer.

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How serious can cancer be?

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The common misconception is that cancer can cause the patient to go insane as soon as cancer affects them. This is not the case. In some patients, cancer evolves over 10 years and there is a lot of research showing that people affected by cancer feel the same as people who have an illness of the same nature, but unlike the patient with cancer, patients with the same disease feel very intense and are not able to go on vacation or travel. Cancer can be very, very serious and it can be the cause of extreme anxiety levels in the patient.

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What are the common side effects of behavioral intervention?

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Behavioral approaches have several common strategies for reducing cancer relapse, including improving awareness, developing coping skills, modifying unhealthy habits, and modifying the natural environment. However, few studies have investigated the specific side effects of behavioral lifestyle interventions for cancer patients. Findings from a recent study demonstrated that this type of intervention is associated with a variety of side effects.

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Have there been any new discoveries for treating cancer?

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The treatment of cancer and other malignant disease over the past two decades has been guided by an understanding of the biology of cancer, improved therapeutic strategies, and better integration of therapies. Recent advancements in the understanding the etiology of cancer and advances in genetic analysis have produced insights that can be used to improve treatment. summary: Data from a recent study documents the history of advances in cancer research.

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Does cancer run in families?

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There is some evidence that CRC cancer of multiple tumors is associated with a higher frequency of hereditary non-polyposis CRC. However, CRC predisposition has a small magnitude.

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