LymphomaNCT02948413
Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials
An observational study of Lymphoma and Mesothelioma, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: A cancer diagnosis is a threat to life and bodily integrity. This can cause people with cancer to experience traumatic stress. Researchers want to better understand the types of stress and emotional reactions people with cancer experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Mesothelioma, Prostate Cancer
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2016to 22 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is open to all people with or who have been treated for cancer at the NIH CC in Bethesda, Maryland and meet the eligibility criteria.
Who may be able to join
- This study is open to all people with or who have been treated for cancer at the NIH CC in Bethesda, Maryland and meet the following criteria. This is done to provide the richest cross-section possible in this availability sample of patients undergoing or post treatment. Eligibility criteria include participants who are:
- Currently diagnosed or have been diagnosed with one of four types of cancer: leukemia, lymphoma, mesothelioma, and prostate cancer. Patients can have any stage of one of these four types of cancer and can be at any point in the treatment continuum, including active treatment, remission, recurrence, and surveillance or watchful waiting. An oncology diagnosis is considered sufficient for this protocol if it is sufficient for the patient to be enrolled in and actively followed on an oncology protocol at the NIH CC;
- Those who are pregnant are eligible to participate;
- Those who are HIV positive or have been diagnosed with AIDS in addition to carrying an oncology diagnosis are eligible to participate;
- Those who are aged 18 and over, as the research instruments have not been validated in individuals under the age of 18;
- Able to understand and willing to sign a written informed consent document to participate in this study;
- Enrolled in and actively followed on a clinical trial at the NIH CC.
- If applicable, agrees to complete study questionnaires on line.
Who cannot join
- Inability to meet the inclusion criteria;
- Inability to provide informed consent;
- Individuals with limited English proficiency as the research instruments have not been translated into or validated in languages other than English.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Exploring the Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials
Background:
A cancer diagnosis is a threat to life and bodily integrity. This can cause people with cancer to experience traumatic stress. Researchers want to better understand the types of stress and emotional reactions people with cancer experience. They also want to know if the stress people with cancer have had during their life affects their stress related to cancer.
Read more
Objective:
To see if lifetime traumas, along with psychosocial distress, can predict traumatic stress symptoms in people with cancer.
Eligibility:
People ages 18 and older who have had or are currently getting care from the NIH Clinical Center for one of these cancers:
Leukemia
Lymphoma
Mesothelioma
Prostate cancer
Design:
Participants will be screened with name, date of birth, and diagnosis.
Participants will allow access to their medical records.
Participants will complete, online or in person, a demographic sheet and 3 questionnaires:
The PTSD Checklist for DSM-5: This assesses traumatic stress symptoms and takes 5 10
minutes to complete.
The Life Events Checklist for DSM-5: This assesses potentially traumatic life events and
takes about 5 minutes to complete.
The Brief Symptoms Inventory 18: This assesses psychosocial distress and takes about 4
minutes to complete....
Read the detailed description
Background:
- The American College of Surgeons requires accredited cancer hospitals to screen for distress.
- Providers at the NIH CC do not uniformly screen for traumatic stress in oncology patients but have observed innumerable patients with deficits in social functioning, difficulty adhering to treatment, and trouble coping due to oncology related traumatic stress.
- A seminal distress study reported the prevalence of distress for 14 cancer diagnoses was as high as 43.4% with prevalence of distress in the 30% range for the diagnoses covered in this study.
- It has been shown that a cancer diagnosis represents a threat to life and bodily integrity and can create a sense of loss of social and occupational roles, causing one s adaptive capacity to become overwhelmed.
- In oncology patients, the literature reports that symptoms or traumatic stress range from 20% with early stage cancer to 80% in those with recurrent disease.
- The outcome of this study will provide information about traumatic stress, aid in the identification of it, and provide guidance on trauma informed care for this population.
Objectives:
- A descriptive study to explore the relationships between levels of psychosocial distress and levels of traumatic stress symptoms (TSS) in patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.
- We will also describe the relationship between psychosocial distress and TSS in the context of the number of lifetime traumas experienced by patients enrolled on a clinical trial at the NIH for cancer treatment.
Eligibility:
- Patients receiving treatment at the NIH CC will be recruited from four diagnostic groups: leukemia, lymphoma, mesothelioma, and prostate.
- Inclusion criteria include: diagnosed and treated for one of four types of cancer (patients can have any stage of one of these four types of cancer and can be at any point in the treatment continuum); aged 18 and over; able to understand and willing to sign a written informed consent document to participate in this study; enrolled in a clinical trial and actively followed on at the NIH CC.
Design:
- This study is an exploratory cross-sectional survey design.
- Data from the standardized measures (e.g. BSI-18, LEC-5, and the PCL-5) and demographic and medical history from the medical charts will describe the sample.
- Protocol participation is estimated to take approximately 10-15 minutes per patient.
- To address the primary objective, a backwards stepwise process will be used to identify covariate variables that will be used in the final model. This will allow for the data to present naturally occurring gaps in p-values to inform significance.
- Bi-variate analysis such as t-tests to compare means, time since diagnosis, time since clinical trials participation (e.g. treatment) and demographics, will be used to explore differences and relationships among the main variables and the demographic and illness-related variables.
- Conditions
- Lymphoma, Mesothelioma, Prostate Cancer, Leukemia
- Keywords
- Traumatic Stress, Oncology, Lymphoma, Leukemia
- Medical subject headings
- Lymphoma, Mesothelioma, Prostatic Neoplasms, Leukemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Group of patients with Cancer | Patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traumatic Stress Symptoms
A descriptive study to explore the relationships between levels of psychosocial distress and levels of traumatic stress symptoms (TSS) in patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.
Measured: Single Time Point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start10 Nov 2016
- Primary completion27 Apr 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jennifer D Hendricks, Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948413
- Sponsor's protocol ID
- 170010
- Other IDs
- 17-CC-0010
- Status last verified
- May 2020
- First submitted
- 27 Oct 2016
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gurevich M, Devins GM, Rodin GM. Stress response syndromes and cancer: conceptual and assessment issues. Psychosomatics. 2002 Jul-Aug;43(4):259-81. doi: 10.1176/appi.psy.43.4.259.
PubMed 12189252Cella DF, Mahon SM, Donovan MI. Cancer recurrence as a traumatic event. Behav Med. 1990 Spring;16(1):15-22. doi: 10.1080/08964289.1990.9934587.
PubMed 2322653Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
PubMed 11180574
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials
- ClinicalTrials.gov ID
- NCT02948413
- Acronym / sponsor ID
- 170010
- Conditions
- Lymphoma, Mesothelioma, Prostate Cancer, Leukemia
- Keywords
- Traumatic Stress, Oncology, Lymphoma, Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
A cancer diagnosis is a threat to life and bodily integrity. This can cause people with cancer to experience traumatic stress. Researchers want to better understand the types of stress and emotional reactions people with cancer experience. They also want to know if the stress people with cancer have had during their life affects their stress related to cancer.
Objective:
To see if lifetime traumas, along with psychosocial distress, can predict traumatic stress symptoms in people with cancer.
Eligibility:
People ages 18 and older who have had or are currently getting care from the NIH Clinical Center for one of these cancers:
Leukemia
Lymphoma
Mesothelioma
Prostate cancer
Design:
Participants will be screened with name, date of birth, and diagnosis.
Participants will allow access to their medical records.
Participants will complete, online or in person, a demographic sheet and 3 questionnaires:
The PTSD Checklist for DSM-5: This assesses traumatic stress symptoms and takes 5 10
minutes to complete.
The Life Events Checklist for DSM-5: This assesses potentially traumatic life events and
takes about 5 minutes to complete.
The Brief Symptoms Inventory 18: This assesses psychosocial distress and takes about 4
minutes to complete....
Detailed description
Background:
- The American College of Surgeons requires accredited cancer hospitals to screen for distress.
- Providers at the NIH CC do not uniformly screen for traumatic stress in oncology patients but have observed innumerable patients with deficits in social functioning, difficulty adhering to treatment, and trouble coping due to oncology related traumatic stress.
- A seminal distress study reported the prevalence of distress for 14 cancer diagnoses was as high as 43.4% with prevalence of distress in the 30% range for the diagnoses covered in this study.
- It has been shown that a cancer diagnosis represents a threat to life and bodily integrity and can create a sense of loss of social and occupational roles, causing one s adaptive capacity to become overwhelmed.
- In oncology patients, the literature reports that symptoms or traumatic stress range from 20% with early stage cancer to 80% in those with recurrent disease.
- The outcome of this study will provide information about traumatic stress, aid in the identification of it, and provide guidance on trauma informed care for this population.
Objectives:
- A descriptive study to explore the relationships between levels of psychosocial distress and levels of traumatic stress symptoms (TSS) in patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.
- We will also describe the relationship between psychosocial distress and TSS in the context of the number of lifetime traumas experienced by patients enrolled on a clinical trial at the NIH for cancer treatment.
Eligibility:
- Patients receiving treatment at the NIH CC will be recruited from four diagnostic groups: leukemia, lymphoma, mesothelioma, and prostate.
- Inclusion criteria include: diagnosed and treated for one of four types of cancer (patients can have any stage of one of these four types of cancer and can be at any point in the treatment continuum); aged 18 and over; able to understand and willing to sign a written informed consent document to participate in this study; enrolled in a clinical trial and actively followed on at the NIH CC.
Design:
- This study is an exploratory cross-sectional survey design.
- Data from the standardized measures (e.g. BSI-18, LEC-5, and the PCL-5) and demographic and medical history from the medical charts will describe the sample.
- Protocol participation is estimated to take approximately 10-15 minutes per patient.
- To address the primary objective, a backwards stepwise process will be used to identify covariate variables that will be used in the final model. This will allow for the data to present naturally occurring gaps in p-values to inform significance.
- Bi-variate analysis such as t-tests to compare means, time since diagnosis, time since clinical trials participation (e.g. treatment) and demographics, will be used to explore differences and relationships among the main variables and the demographic and illness-related variables.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group of patients with Cancer | – | –Patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is open to all people with or who have been treated for cancer at the NIH CC in Bethesda, Maryland and meet the eligibility criteria.
Key inclusion criteria (8 listed)
- This study is open to all people with or who have been treated for cancer at the NIH CC in Bethesda, Maryland and meet the following criteria. This is done to provide the richest cross-section possible in this availability sample of patients undergoing or post treatment. Eligibility criteria include participants who are:
- Currently diagnosed or have been diagnosed with one of four types of cancer: leukemia, lymphoma, mesothelioma, and prostate cancer. Patients can have any stage of one of these four types of cancer and can be at any point in the treatment continuum, including active treatment, remission, recurrence, and surveillance or watchful waiting. An oncology diagnosis is considered sufficient for this protocol if it is sufficient for the patient to be enrolled in and actively followed on an oncology protocol at the NIH CC;
- Those who are pregnant are eligible to participate;
- Those who are HIV positive or have been diagnosed with AIDS in addition to carrying an oncology diagnosis are eligible to participate;
- Those who are aged 18 and over, as the research instruments have not been validated in individuals under the age of 18;
Key exclusion criteria (3 listed)
- Inability to meet the inclusion criteria;
- Inability to provide informed consent;
- Individuals with limited English proficiency as the research instruments have not been translated into or validated in languages other than English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Traumatic Stress Symptoms
Time frame: Single Time Point
A descriptive study to explore the relationships between levels of psychosocial distress and levels of traumatic stress symptoms (TSS) in patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Background: PubMed 12189252Gurevich M, Devins GM, Rodin GM. Stress response syndromes and cancer: conceptual and assessment issues. Psychosomatics. 2002 Jul-Aug;43(4):259-81. doi: 10.1176/appi.psy.43.4.259.
- Background: PubMed 2322653Cella DF, Mahon SM, Donovan MI. Cancer recurrence as a traumatic event. Behav Med. 1990 Spring;16(1):15-22. doi: 10.1080/08964289.1990.9934587.
- Background: PubMed 11180574Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer D Hendricks principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Mesothelioma, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traumatic Stress Symptoms (time frame: Single Time Point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948413, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.