Lymphoma, Non-HodgkinPhase 2NCT00067288
Meaning-Centered Psychotherapy in Advanced Cancer
A Phase 2 study testing Meaning-Centered Group Psychotherapy and Standard Supportive Group Psychotherapy in people with Lymphoma, Non-Hodgkin and Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the limitations of their cancer illness. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Neoplasms
- What is being tested?
- Meaning-Centered Group Psychotherapy and Standard Supportive Group Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Mar 2006
- Phase
- Phase 2
- 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
- 21 years of age or older;
- English speaking;
- Stage III or IV solid-tumor or Non-Hodgkin's Lymphoma;
- Receiving ambulatory care at Memorial Sloan-Kettering Cancer Center in New York City;
Who cannot join
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention;
- Presence of cognitive impairment disorder, such as delirium or dementia that is sufficient, in the investigator's opinion, to preclude meaningful participation and/or informed consent;
- Karnofsky Performance Rating Scale 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 Institute for Cancer Research
New York, New York, 10021
About this study
We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the limitations of their cancer illness. This project's overall aim is to explore the feasibility and efficacy of this new and unique psychotherapy intervention for advanced cancer patients in enhancing psychological and spiritual well-being and quality of life by comparing it with a standard supportive group psychotherapy.
Read the detailed description
As per Brief Summary
- Conditions
- Lymphoma, Non-Hodgkin, Neoplasms
- Being tested
- Meaning-Centered Group Psychotherapy, Standard Supportive Group Psychotherapy
- Keywords
- Stage 3 cancer;, Stage 4 cancer;, solid tumor cancer;, Non-Hodgkin's Lymphoma;, solid tumors;, end-stage cancer;, group psychotherapy;, psychotherapy;, emotional support;, support groups
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Centered Group PsychotherapyBehavioural
Standard Supportive Group PsychotherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2003 (estimated)
- Study startMay 2002
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- William Breitbart, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterChristopher Gibson, PhD, Project Coordinator Memorial Sloan-Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067288
- Sponsor's protocol ID
- R21AT001031-01
- Other IDs
- Breitbart
- Status last verified
- Aug 2006
- First submitted
- 14 Aug 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meaning-Centered Psychotherapy in Advanced Cancer
- ClinicalTrials.gov ID
- NCT00067288
- Acronym / sponsor ID
- R21AT001031-01
- Conditions
- Lymphoma, Non-Hodgkin, Neoplasms
- Keywords
- Stage 3 cancer;, Stage 4 cancer;, solid tumor cancer;, Non-Hodgkin's Lymphoma;, solid tumors;, end-stage cancer;, group psychotherapy;, psychotherapy;
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- May 2002
- Study completion
- Mar 2006
- First posted
- 15 Aug 2003 (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.
We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the limitations of their cancer illness. This project's overall aim is to explore the feasibility and efficacy of this new and unique psychotherapy intervention for advanced cancer patients in enhancing psychological and spiritual well-being and quality of life by comparing it with a standard supportive group psychotherapy.
Detailed description
As per Brief Summary
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 years of age or older;
- English speaking;
- Stage III or IV solid-tumor or Non-Hodgkin's Lymphoma;
- Receiving ambulatory care at Memorial Sloan-Kettering Cancer Center in New York City;
Key exclusion criteria (3 listed)
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention;
- Presence of cognitive impairment disorder, such as delirium or dementia that is sufficient, in the investigator's opinion, to preclude meaningful participation and/or informed consent;
- Karnofsky Performance Rating Scale 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 Psychotherapy | Behavioural | – |
| Standard Supportive Group Psychotherapy | Behavioural | – |
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 18 Aug 2006.
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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
Christopher Gibson, PhD
Project Coordinator 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 2 study testing Meaning-Centered Group Psychotherapy and Standard Supportive Group Psychotherapy in people with Lymphoma, Non-Hodgkin and Neoplasms, run by National Center for Complementary and Integrative Health (NCCIH) 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 18 Aug 2006. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
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 18 Aug 2006.