NCT00179387

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2016

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

11.2 years

First QC Date

September 13, 2005

Last Update Submit

May 28, 2023

Conditions

Neoplasms

Keywords

NeoplasmsNeeds AssessmentAdaptation PsychologicalMinority GroupsPsychotherapy, GroupProgram EvaluationSpiritualitySpiritual Therapies

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Cancer Therapy

    baseline to 2 months and 4 months

Study Arms (2)

1

ACTIVE COMPARATOR

Psycho-educational / Stress Management group

Behavioral: Mind-Body Psychotherapy Group

2

ACTIVE COMPARATOR

Spiritual-Existential Support Group

Behavioral: Mind-Body Psychotherapy Group

Interventions

Mind-Body Psychotherapy GroupBEHAVIORAL

Psycho-educational group

Also known as: Stress Management Group
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

    PMID: 23916058DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Alyson Moadel, Ph.D.

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

December 1, 2004

Primary Completion

February 25, 2016

Study Completion

February 25, 2016

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

US(1)