NeoplasmsNCT00179387
Mind-Body Program for Cancer Patients
A study testing Mind-Body Psychotherapy Group in people with Neoplasms, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Mind-Body Psychotherapy Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2004to 25 Feb 2016
- Phase
- Interventional
- 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
Who may be able to join
- On Active Treatment for:
- Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III \& IV, or All Other Cancers (ANY stage on treatment)
- Language is English or Spanish
Who cannot join
- Patient is currently attending other support/psychotherapy group
- Significant Cognitive Impairment
- ECOG performance status = 3 or 4
- Current major untreated psychiatric disorder
- Unable to attend intervention in following 8 weeks due to medical or practical restrictions
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients
The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.
Read the detailed description
Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.
- Conditions
- Neoplasms
- Being tested
- Mind-Body Psychotherapy Group
- Keywords
- Neoplasms, Needs Assessment, Adaptation Psychological, Minority Groups, Psychotherapy, Group, Program Evaluation, Spirituality, Spiritual Therapies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Psychotherapy GroupBehavioural
Also called Stress Management Group
Psycho-educational group
Mind-Body Psychotherapy GroupBehavioural
Also called Spiritual Support Group
Spiritual-Existential Group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Psycho-educational / Stress Management group Receives: Behavioral: Mind-Body Psychotherapy Group |
| 2 | Active comparator | Spiritual-Existential Support Group Receives: Behavioral: Mind-Body Psychotherapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy
Measured: baseline to 2 months and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start1 Dec 2004
- Primary completion25 Feb 2016
- Study completion25 Feb 2016
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 NeoplasmsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Alyson Moadel, Ph.D., Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179387
- Sponsor's protocol ID
- 2003-412
- Other IDs
- ACS Research Scholar's Grant
- Status last verified
- May 2023
- First submitted
- 13 Sep 2005
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stein EM, Kolidas E, Moadel A. Do spiritual patients want spiritual interventions?: A qualitative exploration of underserved cancer patients' perspectives on religion and spirituality. Palliat Support Care. 2015 Feb;13(1):19-25. doi: 10.1017/S1478951513000217. Epub 2013 Aug 6.
PubMed 23916058
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients
- ClinicalTrials.gov ID
- NCT00179387
- Acronym / sponsor ID
- 2003-412
- Conditions
- Neoplasms
- Keywords
- Neoplasms, Needs Assessment, Adaptation Psychological, Minority Groups, Psychotherapy, Group, Program Evaluation, Spirituality, Spiritual Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 1 Dec 2004 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 25 Feb 2016 (actual)
- First posted
- 16 Sep 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.
The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.
Detailed description
Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Mind-Body Psychotherapy GroupPsycho-educational / Stress Management group |
| 2 | Active comparator | Behavioral: Mind-Body Psychotherapy GroupSpiritual-Existential Support Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On Active Treatment for:
- Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III \& IV, or All Other Cancers (ANY stage on treatment)
- Language is English or Spanish
Key exclusion criteria (5 listed)
- Patient is currently attending other support/psychotherapy group
- Significant Cognitive Impairment
- ECOG performance status = 3 or 4
- Current major untreated psychiatric disorder
- Unable to attend intervention in following 8 weeks due to medical or practical restrictions
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 |
|---|---|---|
| Mind-Body Psychotherapy GroupAlso: Stress Management GroupPsycho-educational group | Behavioural | 1 |
| Mind-Body Psychotherapy GroupAlso: Spiritual Support GroupSpiritual-Existential Group | Behavioural | 2 |
Primary outcome
Functional Assessment of Cancer Therapy
Time frame: baseline to 2 months and 4 months
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 31 May 2023.
- Derived from this study: PubMed 23916058Stein EM, Kolidas E, Moadel A. Do spiritual patients want spiritual interventions?: A qualitative exploration of underserved cancer patients' perspectives on religion and spirituality. Palliat Support Care. 2015 Feb;13(1):19-25. doi: 10.1017/S1478951513000217. Epub 2013 Aug 6.
- Support programs for cancer patients \& their families in the BronxLink 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.
Alyson Moadel, Ph.D. principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Psychotherapy Group in people with Neoplasms, run by Albert Einstein College of Medicine 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 3 inclusion and 5 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 31 May 2023. 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?
Functional Assessment of Cancer Therapy (time frame: baseline to 2 months and 4 months). 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 NCT00179387, 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 31 May 2023.