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CompletedNCT00179387Updated May 31, 2023

Mind-Body Program for Cancer Patients

An interventional study of Mind-Body Psychotherapy Group and Mind-Body Psychotherapy Group in Neoplasms, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Dec 2004, registered Sep 2005).
Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Neoplasms

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Keywords

  • Neoplasms
  • Needs Assessment
  • Adaptation Psychological
  • Minority Groups
  • Psychotherapy, Group
  • Program Evaluation
  • Spirituality
  • Spiritual Therapies
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 166 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
166 participants (actual)

Study arms

  • Active comparator
    1

    Psycho-educational / Stress Management group

    Behavioral: Mind-Body Psychotherapy Group

  • Active comparator
    2

    Spiritual-Existential Support Group

    Behavioral: Mind-Body Psychotherapy Group

Interventions

  • BehavioralMind-Body Psychotherapy Group

    Psycho-educational group

    Also known as: Stress Management Group

  • BehavioralMind-Body Psychotherapy Group

    Spiritual-Existential Group

    Also known as: Spiritual Support Group

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What researchers measure

Primary outcomes

  1. Functional Assessment of Cancer Therapy

    Time frame: baseline to 2 months and 4 months

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Study locations

1 site
  • Albert Einstein College of Medicine
    Bronx, New York 10461, United States
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00179387
Lead sponsor
Albert Einstein College of Medicine
Collaborators
American Cancer Society, Inc.
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Dec 1, 2004
Primary completion
Feb 25, 2016
Completion
Feb 25, 2016
Last update
May 31, 2023

Study contacts

Alyson Moadel, Ph.D.
principal investigator · Albert Einstein College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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