Lung CancerNCT00364078
Transitoriness in Cancer Patients, Psychosocial Issues in Cancer Care
An observational study of Lung Cancer and Gastrointestinal Cancers, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
Transitoriness can be defined as confrontation with life's finitude. Cancer patients are perceived to experience this confrontation due to their diagnosis. It is perceived to impact cancer patients' ways of coping with the disease situation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer, Gastrointestinal Cancers
- How many people
- 193 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Aug 2007
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Johns Hopkins University Medical Institutions
Who may be able to join
- Lung and gastrointestinal cancer diagnoses at various stages
- Inpatient or outpatient of Johns Hopkins Hospital, Sidney Kimmel Cancer Center, Bayview Medical Center or Greensprings Station
- Ability to read and understand English
- 18 years or older
- Patients have been informed of the serious/terminal nature of their cancer diagnosis
- Physically and mentally fit
- Diverse ethnic background
Who cannot join
- Observable evidence of confusion (researcher will consult with psychiatric liaison nurse if the patient is not oriented to time,place and person).
- Patients who experience pain or other discomforting symptoms
- Receiving hospice care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Transitoriness in Cancer Patients: a Cross-Sectional Study of Uncertainty, Locus of Control, Quality of Life and Existentials Views on Finality of Life in Cancer Patients
Transitoriness can be defined as confrontation with life's finitude. Cancer patients are perceived to experience this confrontation due to their diagnosis. It is perceived to impact cancer patients' ways of coping with the disease situation. In this study, cancer patients' levels of uncertainty, transitoriness and their perceived locus of control are assessed. It is aimed at exploring the association of uncertainty, locus of control, transitoriness and quality of life. If a stronger correlation of one or the other issue with quality of life can be discovered, it will inform the development of an adequate evidence-based nursing intervention to better support patients' coping with the disease.
Read the detailed description
Cancer is the second leading cause of death among individuals in the United States of America (Ries et al., 2000). Gastro-intestinal (GI) cancers account for approximately 253,500 new cases each year in both men and women. Most of the patients with GI cancer have a poor outcome (American Cancer Society., 2005; Ilson, 2001), accounting for approximately 16% of cancer related death in women and 25% of cancer related death in men (American Cancer Society, 2005). Of all cancers, lung cancer is the leading cause for death among men and women (American Cancer Society., 2005).
GI cancer constitutes a disease with intensive medical research focused on the improvement of prevention, early detection and treatment. How patients with GI cancer deal with the diagnosis remains understudied to date. Lung cancer research has focused particularly on smoking and its impact on lung cancer epidemiology. Lung cancer patients' coping strategies have been studied. Issues related to the meaning of life, health and self-care, physical functioning, coping and support have been highlighted as being important in lung cancer patients' dealing with their disease situation (Maliski, Sarna, Evangelista, \& Padilla, 2003; Sharf, Stelljes, \& Gordon, 2005). Similarly, patients' dealing with a diagnosis of breast cancer has been investigated (Andritsch et al., 2004; Badger, Braden, Mishel, \& Longman, 2004; Northouse, Templin, Mood, \& Oberst, 1998). Constructs such as uncertainty and locus control are highly important in coping with the disease situation. Uncertainty has been linked with quality of life (Sammarco, 2001;2003). Evidence also exists that transitoriness, which is the confrontation with the finitude of human life, plays an important role in how individuals cope (Cohen et al., 2004; Shaha \& Cox, 2003). The interrelationship between and among transitoriness, uncertainty and locus of control has yet to be delineated. There is also a need to explore transitoriness more fully as it has mainly been subsumed in concepts such as 'finding meaning in illness' or 'anxiety' (Houldin, 2003). Transitoriness has been linked with patient outcomes such as quality of life (Houldin, 2003). It is necessary to explore the concept of transitoriness to establish its links with uncertainty and locus of control. It is equally important to explore the association of these three concepts together with patients' psycho-social well-being and quality of life. By exploring these associations, the individual's way of coping with the cancer diagnosis will be better understood and lead to the development of nursing interventions to support persons with cancer, especially those with lung and GI cancer.
It will then be possible a) to explore the concept of transitoriness by describing its interrelationship with uncertainty and locus of control, and b) to investigate the association among transitoriness, uncertainty, locus of control, psycho-social well-being and quality of life. The following research questions will be addressed in the study:
- Is cancer patients' confrontation with life's finitude related to uncertainty and locus of control?
- Are cancer patients' confrontation with life's finitude, uncertainty and locus of control associated with psychosocial well-being and quality of life?
- Are there differences in these associations between patients with different forms of cancer?
- Conditions
- Lung Cancer, Gastrointestinal Cancers
- Keywords
- Cross-sectional correlational study, Uncertainty, Locus of Control, Quality of life, Transitoriness, Cancer care
- Medical subject headings
- Lung Neoplasms, Gastrointestinal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cancer League, Johns Hopkins University
- Investigators
- Anne E Belcher, PhD, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364078
- Sponsor's protocol ID
- J0601
- Other IDs
- BIL OCS 01532-03-2004, Dorothy Evans Lyne Fund
- Status last verified
- May 2008
- First submitted
- 14 Aug 2006
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Shaha M, Cox CL. The omnipresence of cancer. Eur J Oncol Nurs. 2003 Sep;7(3):191-6. doi: 10.1016/s1462-3889(03)00026-7.
PubMed 12932481Shaha M. [Life with intestinal cancer. A phenomenologic-empirical study]. Pflege. 2003 Dec;16(6):323-30. doi: 10.1024/1012-5302.16.6.323. German.
PubMed 14964130Shaha M, Cox C, Porrett T, Hall A.The omnipresence of cancer and its practice implications for colorectal cancer. Cancer Nursing Practice, 5(4): 35 - 39, 2006
Shaha M, Cox CL, Talman K, Kelly D. Uncertainty in breast, prostate, and colorectal cancer: implications for supportive care. J Nurs Scholarsh. 2008;40(1):60-7. doi: 10.1111/j.1547-5069.2007.00207.x.
PubMed 18302593
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitoriness in Cancer Patients: a Cross-Sectional Study of Uncertainty, Locus of Control, Quality of Life and Existentials Views on Finality of Life in Cancer Patients
- ClinicalTrials.gov ID
- NCT00364078
- Acronym / sponsor ID
- J0601
- Conditions
- Lung Cancer, Gastrointestinal Cancers
- Keywords
- Cross-sectional correlational study, Uncertainty, Locus of Control, Quality of life, Transitoriness, Cancer care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Swiss Cancer League, Johns Hopkins University
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Aug 2006 (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.
Transitoriness can be defined as confrontation with life's finitude. Cancer patients are perceived to experience this confrontation due to their diagnosis. It is perceived to impact cancer patients' ways of coping with the disease situation. In this study, cancer patients' levels of uncertainty, transitoriness and their perceived locus of control are assessed. It is aimed at exploring the association of uncertainty, locus of control, transitoriness and quality of life. If a stronger correlation of one or the other issue with quality of life can be discovered, it will inform the development of an adequate evidence-based nursing intervention to better support patients' coping with the disease.
Detailed description
Cancer is the second leading cause of death among individuals in the United States of America (Ries et al., 2000). Gastro-intestinal (GI) cancers account for approximately 253,500 new cases each year in both men and women. Most of the patients with GI cancer have a poor outcome (American Cancer Society., 2005; Ilson, 2001), accounting for approximately 16% of cancer related death in women and 25% of cancer related death in men (American Cancer Society, 2005). Of all cancers, lung cancer is the leading cause for death among men and women (American Cancer Society., 2005).
GI cancer constitutes a disease with intensive medical research focused on the improvement of prevention, early detection and treatment. How patients with GI cancer deal with the diagnosis remains understudied to date. Lung cancer research has focused particularly on smoking and its impact on lung cancer epidemiology. Lung cancer patients' coping strategies have been studied. Issues related to the meaning of life, health and self-care, physical functioning, coping and support have been highlighted as being important in lung cancer patients' dealing with their disease situation (Maliski, Sarna, Evangelista, \& Padilla, 2003; Sharf, Stelljes, \& Gordon, 2005). Similarly, patients' dealing with a diagnosis of breast cancer has been investigated (Andritsch et al., 2004; Badger, Braden, Mishel, \& Longman, 2004; Northouse, Templin, Mood, \& Oberst, 1998). Constructs such as uncertainty and locus control are highly important in coping with the disease situation. Uncertainty has been linked with quality of life (Sammarco, 2001;2003). Evidence also exists that transitoriness, which is the confrontation with the finitude of human life, plays an important role in how individuals cope (Cohen et al., 2004; Shaha \& Cox, 2003). The interrelationship between and among transitoriness, uncertainty and locus of control has yet to be delineated. There is also a need to explore transitoriness more fully as it has mainly been subsumed in concepts such as 'finding meaning in illness' or 'anxiety' (Houldin, 2003). Transitoriness has been linked with patient outcomes such as quality of life (Houldin, 2003). It is necessary to explore the concept of transitoriness to establish its links with uncertainty and locus of control. It is equally important to explore the association of these three concepts together with patients' psycho-social well-being and quality of life. By exploring these associations, the individual's way of coping with the cancer diagnosis will be better understood and lead to the development of nursing interventions to support persons with cancer, especially those with lung and GI cancer.
It will then be possible a) to explore the concept of transitoriness by describing its interrelationship with uncertainty and locus of control, and b) to investigate the association among transitoriness, uncertainty, locus of control, psycho-social well-being and quality of life. The following research questions will be addressed in the study:
- Is cancer patients' confrontation with life's finitude related to uncertainty and locus of control?
- Are cancer patients' confrontation with life's finitude, uncertainty and locus of control associated with psychosocial well-being and quality of life?
- Are there differences in these associations between patients with different forms of cancer?
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Johns Hopkins University Medical Institutions
Key inclusion criteria (7 listed)
- Lung and gastrointestinal cancer diagnoses at various stages
- Inpatient or outpatient of Johns Hopkins Hospital, Sidney Kimmel Cancer Center, Bayview Medical Center or Greensprings Station
- Ability to read and understand English
- 18 years or older
- Patients have been informed of the serious/terminal nature of their cancer diagnosis
Key exclusion criteria (3 listed)
- Observable evidence of confusion (researcher will consult with psychiatric liaison nurse if the patient is not oriented to time,place and person).
- Patients who experience pain or other discomforting symptoms
- Receiving hospice care
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
Not reported in the source record.
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 21 May 2008.
- Background: PubMed 12932481Shaha M, Cox CL. The omnipresence of cancer. Eur J Oncol Nurs. 2003 Sep;7(3):191-6. doi: 10.1016/s1462-3889(03)00026-7.
- Background: PubMed 14964130Shaha M. [Life with intestinal cancer. A phenomenologic-empirical study]. Pflege. 2003 Dec;16(6):323-30. doi: 10.1024/1012-5302.16.6.323. German.
- BackgroundShaha M, Cox C, Porrett T, Hall A.The omnipresence of cancer and its practice implications for colorectal cancer. Cancer Nursing Practice, 5(4): 35 - 39, 2006
- Background: PubMed 18302593Shaha M, Cox CL, Talman K, Kelly D. Uncertainty in breast, prostate, and colorectal cancer: implications for supportive care. J Nurs Scholarsh. 2008;40(1):60-7. doi: 10.1111/j.1547-5069.2007.00207.x.
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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.
Anne E Belcher, PhD principal investigator
Johns Hopkins School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Gastrointestinal Cancers, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites 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 7 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 21 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00364078, which also lists 4 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 21 May 2008.