Psychosocial Support for Cancer Patients - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00133965

Purpose

This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing 120 patients per site (120x3). The purpose of this study is to compare two types of counseling for cancer patients: "Dignity Psychotherapy" and "Supportive Psychotherapy" as well as "Standard Palliative Care." Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. We, the investigators at Memorial Sloan-Kettering Cancer Center, have developed a type of counseling we call "Dignity Psychotherapy." It is intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall quality of life, despite having cancer. "Supportive Psychotherapy" is another type of counseling intended to help patients feel more at ease and express and reflect on any feelings or concerns they might have about their illness. Both of these types of counseling will be compared to "Standard Palliative Care." We will look at how these types of treatments affect patients' mood, outlook, and quality of life. We also want to see how the type of treatment they receive affects their family members and significant others.

Condition	Intervention
Cancer	Behavioral: Dignity Psychotherapy Behavioral: Supportive Psychotherapy Behavioral: Standard Palliative Care

MedlinePlus related topics: Cancer Palliative Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Psychosocial Support for Cancer Patients

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To establish the efficacy of a new and unique individual, brief intervention called "Dignity Psychotherapy" in enhancing a sense of meaning, purpose and overall well-being for patients with advanced, end stage cancer [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the effectiveness of "Dignity Psychotherapy" with "Supportive Psychotherapy" and "Standard Palliative Care" in bolstering the patients' sense of meaning [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
To explore the impact "Dignity Psychotherapy" has on the bereavement experience of those family members/significant others taking part in this arm of the study protocol [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
To compare the bereavement experience of bereaved family members/significant others whose loved ones took part in any one of the three study conditions [ Time Frame: Six to nine months following the death of the patient ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Dignity Psychotherapy	Behavioral: Dignity Psychotherapy At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires.will also receive three visits by a mental health professional over a period of five to seven days. You will be asked to fill out some brief questionnaires during this session which ask about feelings about your illness, symptoms, emotional reactions, and support you have available. The second meeting will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the Research Staff.The third meeting you will also be asked to fill out several questionnaires,including a specific questionnaire regarding your thoughts about the Dignity Psychotherapy Intervention. Total time commitment for this study should be approximately 120-150 minutes.
2: Active Comparator Supportive Psychotherapy	Behavioral: Supportive Psychotherapy you will receive the standard care you normally would receive, but will also receive three visits by a mental health professional over a period of five to seven days. The initial visit will take approximately 45 minutes. You will be asked to fill out brief questionnaires (described above) during this session.A second contact will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the research staff. During this second session, you will have the opportunity to discuss with a supportive research therapist issues or topics relevant to your experience of coping with cancer.The third and final contact,you will be asked you to fill out questionnaires similar to those you filled out at the beginning of the study. Total time commitment for this study should be approximately 120-150 minutes.
3: Active Comparator Standard Palliative Care	Behavioral: Standard Palliative Care If you are in the "Standard Palliative Care" group you will receive the standard care that is usually provided here at Memorial Hospital. This can include services such as consultations by physicians, nurses and other healthcare professionals. In addition, referrals to community resources and services can also be made. The study period will be between five and seven days. At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires as described above. Total time commitment for this study should be approximately 60-90 minutes.

Detailed Description:

Primary Objective:

To establish the efficacy of a new and unique individual, brief intervention we call "Dignity Psychotherapy" in enhancing a sense of meaning, purpose and overall well-being for patients with advanced, end stage cancer.

Secondary Objectives:

To compare the effectiveness of "Dignity Psychotherapy" with "Supportive Psychotherapy" and "Standard Palliative Care" in bolstering the patients' sense of meaning, purpose, generativity, and overall sense of dignity and quality of life, while lessening hopelessness, sense of being a burden to others, and suffering.
To explore the impact "Dignity Psychotherapy" has on the bereavement experience of those family members/significant others taking part in this arm of the study protocol.
To compare the bereavement experience of bereaved family members/significant others whose loved ones took part in any one of the three study conditions.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient must be at least 18 years of age (because of the nature of "Dignity Psychotherapy," which presumes a relatively advanced level of social and psychological development).
Have a terminal illness (Stage IV with a prognosis of less than 6 months, but expected to live at least 7 to 10 days, i.e. the average length of the protocol)
Must be able to identify a family member/significant other who agrees to participate in the study (in the case of "Dignity Psychotherapy," this family member/significant other will receive the generativity document)
Be able to communicate with an English-speaking therapist (patients who are visually impaired will be offered assistance with the consent forms and surveys)
In the investigator's judgement, participant is cognitively able to provide valid, informed consent.

Exclusion Criteria:

Significant psychiatric disturbance sufficient to preclude participation in a psychotherapeutic intervention (e.g. acute, severe psychiatric symptoms which would require individual treatment and medication management rather than a psychotherapy intervention).
Active psychotic mental disorder (e.g. schizophrenia, acute mania), or marked paranoid ideation. Patients who are on stable regimens of psychotropic medications (e.g. antidepressants for clinical depression) or who are in concurrent individual or group psychotherapy will not be excluded.
Presence of a cognitive disturbance (i.e. delirium or dementia) sufficient to preclude participation in psychotherapy, and/or data collection.
Physical limitations or illness severity sufficient to preclude participation in psychotherapy i.e. < 30 on the Palliative Performance Scale

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133965

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

William Breitbart, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan Kettering Cancer Center ( William Breitbart, MD )
Study ID Numbers:	05-042
Study First Received:	August 23, 2005
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00133965
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Advanced Cancer
Dignity Care
Supportive Care
Quality of Life

Psychotherapy
Palliative Care
Advanced Cancer

Study placed in the following topic categories:

Quality of Life

ClinicalTrials.gov processed this record on January 14, 2009