Palliative CarePhase 3NCT00494910
Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
A Phase 3 study testing Meaning Centered Group Psychotherapy and Supportive Group Psychotherapy in people with Palliative Care, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- Meaning Centered Group Psychotherapy and Supportive Group Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2007to 5 Mar 2024
- Phase
- Phase 3
- 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
Who may be able to join
- > or = to 21 years of age.
- All patients with stage IV solid tumor cancers; or Stage III solid tumor cancers(excluding breast and prostate cancer) who are receiving ambulatory care at Memorial Sloan-Kettering Cancer Center.
- Able to communicate with an English speaking therapist
- Able to comprehend English to complete study assessments
Who cannot join
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention (i.e., acute psychiatric symptoms which require individual treatment).
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient, in the investigator's judgment, to preclude meaningful informed consent and/or data collection. The Mini Mental State Examination (MMSE) will be used as a cognitive screening tool. Patients with MMSE scores below 20 will be excluded.
- Karnofsky Performance Rating Scale score below 50 or physical limitations or illness severity sufficient to preclude participation in outpatient group 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
Official title: A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. 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. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients.
Read the detailed description
To conduct a randomized controlled trial comparing the efficacy of Meaning-Centered Group Psychotherapy (MCGP) versus a standardized Supportive Group Psychotherapy (SGP) in reducing psychological distress (depression and anxiety), end-of-life despair (hopelessness, desire for hastened death, and suicidal ideation), and improving spiritual well-being and overall quality of life in a sample patients with advanced cancer.
To assess the relative impact of Meaning-Centered Group Psychotherapy on different aspects of spiritual well-being (e.g., a sense of meaning and purpose versus spirituality linked to religious faith).
To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy (e.g., potential mediating and moderating influences such as illness severity, religion and religiosity, level of education, race/ethnicity, level of pre-intervention social support, presence of pain and physical symptom burden).
- Conditions
- Palliative Care
- Being tested
- Meaning Centered Group Psychotherapy, Supportive Group Psychotherapy
- Keywords
- Palliative Care, Terminally Ill, Group Therapy, 07-094
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning Centered Group PsychotherapyBehavioural
this eight-week (1 ½ hour weekly sessions) Session 1 - Concepts of Meaning and Sources of Meaning Session 2 - Cancer and Meaning Session 3 - Meaning and Historical Context of Life Session 4 - Storytelling, Legacy Project (optional) Session 5 - Limitations and Finiteness of Life Session 6 - Responsibility, Creativity, Deeds Session 7 - Experience, Nature, Art, Humor Session 8 - Transitions, Goodbyes, Hopes for the Future
Supportive Group PsychotherapyBehavioural
The eight weekly 1 ½ hour sessions will focus on group discussion on a set of specific themes that emerge for patients coping with cancer. The session themes or topics will include such issues as: the discussion of strategies for coping with medical issues and procedures, communication with health care providers and issues related to family, friends, and occupational life.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Meaning Centered Group Psychotherapy (MCGP) Receives: Behavioral: Meaning Centered Group Psychotherapy |
| 2 | Active comparator | standardized Supportive Group Psychotherapy Receives: Behavioral: Supportive Group Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life).
Measured: 16 weeks
Secondary outcomes (1)
To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study start26 Jun 2007
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
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 Palliative CareStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fordham University
- Responsible party
- Sponsor
- Investigators
- William Breitbart, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494910
- Sponsor's protocol ID
- 07-094
- Status last verified
- Apr 2024
- First submitted
- 29 Jun 2007
- Last updated
- 11 Apr 2024
- Results posted
- No
Publications
Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015 Mar 1;33(7):749-54. doi: 10.1200/JCO.2014.57.2198. Epub 2015 Feb 2.
PubMed 25646186
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
- ClinicalTrials.gov ID
- NCT00494910
- Acronym / sponsor ID
- 07-094
- Conditions
- Palliative Care
- Keywords
- Palliative Care, Terminally Ill, Group Therapy, 07-094
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Fordham University
- Study start
- 26 Jun 2007 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 2 Jul 2007 (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.
The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. 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. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients.
Detailed description
To conduct a randomized controlled trial comparing the efficacy of Meaning-Centered Group Psychotherapy (MCGP) versus a standardized Supportive Group Psychotherapy (SGP) in reducing psychological distress (depression and anxiety), end-of-life despair (hopelessness, desire for hastened death, and suicidal ideation), and improving spiritual well-being and overall quality of life in a sample patients with advanced cancer.
To assess the relative impact of Meaning-Centered Group Psychotherapy on different aspects of spiritual well-being (e.g., a sense of meaning and purpose versus spirituality linked to religious faith).
To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy (e.g., potential mediating and moderating influences such as illness severity, religion and religiosity, level of education, race/ethnicity, level of pre-intervention social support, presence of pain and physical symptom burden).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Meaning Centered Group PsychotherapyMeaning Centered Group Psychotherapy (MCGP) |
| 2 | Active comparator | Behavioral: Supportive Group Psychotherapystandardized Supportive Group Psychotherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > or = to 21 years of age.
- All patients with stage IV solid tumor cancers; or Stage III solid tumor cancers(excluding breast and prostate cancer) who are receiving ambulatory care at Memorial Sloan-Kettering Cancer Center.
- Able to communicate with an English speaking therapist
- Able to comprehend English to complete study assessments
Key exclusion criteria (3 listed)
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention (i.e., acute psychiatric symptoms which require individual treatment).
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient, in the investigator's judgment, to preclude meaningful informed consent and/or data collection. The Mini Mental State Examination (MMSE) will be used as a cognitive screening tool. Patients with MMSE scores below 20 will be excluded.
- Karnofsky Performance Rating Scale score below 50 or physical limitations or illness severity sufficient to preclude participation in outpatient group 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 |
|---|---|---|
| Meaning Centered Group Psychotherapythis eight-week (1 ½ hour weekly sessions) Session 1 - Concepts of Meaning and Sources of Meaning Session 2 - Cancer and Meaning Session 3 - Meaning and Historical Context of Life Session 4 - Storytelling, Legacy Project (optional) Session 5 - Limitations and Finiteness of Life Session 6 - Responsibility, Creativity, Deeds Session 7 - Experience, Nature, Art, Humor Session 8 - Transitions, Goodbyes, Hopes for the Future | Behavioural | 1 |
| Supportive Group PsychotherapyThe eight weekly 1 ½ hour sessions will focus on group discussion on a set of specific themes that emerge for patients coping with cancer. The session themes or topics will include such issues as: the discussion of strategies for coping with medical issues and procedures, communication with health care providers and issues related to family, friends, and occupational life. | Behavioural | 2 |
Primary outcome
The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life).
Time frame: 16 weeks
1 secondary outcome
To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy.
Time frame: 16 weeks
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 11 Apr 2024.
- Derived from this study: PubMed 25646186Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015 Mar 1;33(7):749-54. doi: 10.1200/JCO.2014.57.2198. Epub 2015 Feb 2.
- 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?
A Phase 3 study testing Meaning Centered Group Psychotherapy and Supportive Group Psychotherapy in people with Palliative Care, 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 4 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 11 Apr 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). (time frame: 16 weeks). 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 NCT00494910, 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 11 Apr 2024.