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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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:

  1. Is cancer patients' confrontation with life's finitude related to uncertainty and locus of control?
  2. Are cancer patients' confrontation with life's finitude, uncertainty and locus of control associated with psychosocial well-being and quality of life?
  3. Are there differences in these associations between patients with different forms of cancer?
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.

  1. First posted15 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionMay 2007
  4. Study completionAug 2007

Resources

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)
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 12932481
  • Shaha 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 14964130
  • Shaha 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

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.

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