CancerNCT00133965
Psychosocial Support for Cancer Patients
An observational study of Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Dignity Psychotherapy, Supportive Psychotherapy and Standard Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Apr 2011
- 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: Patients will be recruited from the Pain and Palliative Care Service and Gastrointestinal Service of the Memorial Sloan Kettering Cancer Center.
Who may be able to join
- 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.
Who cannot join
- 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. This information regarding concurrent psychiatric treatment will be collected and utilized as a co-variate in data analysis.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Dignity Psychotherapy, Supportive Psychotherapy, Standard Palliative Care
- Keywords
- Advanced Cancer, Dignity Care, Supportive Care, Quality of Life, Psychotherapy, Palliative Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignity PsychotherapyBehavioural
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.
Supportive PsychotherapyBehavioural
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.
Standard Palliative CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Dignity Psychotherapy Receives: Behavioral: Dignity Psychotherapy | |
| 2 | Supportive Psychotherapy Receives: Behavioral: Supportive Psychotherapy | |
| 3 | Standard Palliative Care Receives: Behavioral: Standard Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7-10 days
Secondary outcomes (3)
To compare the effectiveness of "Dignity Psychotherapy" with "Supportive Psychotherapy" and "Standard Palliative Care" in bolstering the patients' sense of meaning
Measured: 7-10 days
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
Measured: 7-10 days
To compare the bereavement experience of bereaved family members/significant others whose loved ones took part in any one of the three study conditions
Measured: Six to nine months following the death of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Manitoba, Edith Cowan University, Visiting Nurse Service of New York
- Investigators
- William Breitbart, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133965
- Sponsor's protocol ID
- 05-042
- Status last verified
- Apr 2011
- First submitted
- 23 Aug 2005
- Last updated
- 20 Apr 2011
- Results posted
- No
Publications
Chochinov HM, Kristjanson LJ, Breitbart W, McClement S, Hack TF, Hassard T, Harlos M. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol. 2011 Aug;12(8):753-62. doi: 10.1016/S1470-2045(11)70153-X. Epub 2011 Jul 6.
PubMed 21741309
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Support for Cancer Patients
- ClinicalTrials.gov ID
- NCT00133965
- Acronym / sponsor ID
- 05-042
- Conditions
- Cancer
- Keywords
- Advanced Cancer, Dignity Care, Supportive Care, Quality of Life, Psychotherapy, Palliative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Manitoba, Edith Cowan University, Visiting Nurse Service of New York
- Study start
- May 2005
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Aug 2005 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Dignity PsychotherapyDignity Psychotherapy |
| 2 | – | Behavioral: Supportive PsychotherapySupportive Psychotherapy |
| 3 | – | Behavioral: Standard Palliative CareStandard Palliative Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the Pain and Palliative Care Service and Gastrointestinal Service of the Memorial Sloan Kettering Cancer Center.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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. This information regarding concurrent psychiatric treatment will be collected and utilized as a co-variate in data analysis.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dignity PsychotherapyAt 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. | Behavioural | 1 |
| Supportive Psychotherapyyou 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. | Behavioural | 2 |
| Standard Palliative CareIf 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. | Behavioural | 3 |
Primary outcome
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
3 secondary outcomes
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
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
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
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 20 Apr 2011.
- Derived from this study: PubMed 21741309Chochinov HM, Kristjanson LJ, Breitbart W, McClement S, Hack TF, Hassard T, Harlos M. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol. 2011 Aug;12(8):753-62. doi: 10.1016/S1470-2045(11)70153-X. Epub 2011 Jul 6.
- Memorial Sloan-Kettering Cancer CenterLink 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.
William Breitbart, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Cancer, run by Memorial Sloan Kettering Cancer Center 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 5 inclusion and 4 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 20 Apr 2011. 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?
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). 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 NCT00133965, which also lists 1 linked publication.
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 20 Apr 2011.