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A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients


N/A
21 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumor Diseases

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Trial Information

A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients


Inclusion Criteria:



- 21 years of age and older

- Able to communicate and understand English well enough to complete assessments and
intervention**

- Patients solid tumors with advanced disease receiving ambulatory care at MSKCC*.

- Distress Thermometer rating of 4 or greater*

- Patients who do not meet these eligibility criteria may be offered participation
as a training case (See inclusion criteria for Training Cases below).

- The study treatment manual materials and assessments were designed and
validated in English and are not currently available in other languages.
Translation of the intervention and questionnaires into other languages
would require reestablishing the reliability and validity of them.
Therefore, participants must be able to communicate in English

Subject Inclusion Criteria- Training Cases

- 21 years of age and older

- Able to communicate and understand English well enough to complete the intervention**

- Patients with solid tumors with advanced disease receiving ambulatory care at MSKCC
with a Distress Thermometer rating of 3 or less. or Patients with solid tumors who do
not meet eligibility criteria for advanced disease receiving ambulatory care at
MSKCC.

or Patients solid tumors with advanced disease receiving ambulatory care at MSKCC who have
participated in a prior meaning focused intervention study.

Exclusion Criteria:

- In the judgment of the treating physician and/or the consenting professional,
presence of significant cognitive impairment (i.e., delirium or dementia) sufficient
to preclude meaningful informed consent and/or data collection.

- Baseline Karnofsky Performance Rating Scale (KPRS) score below 60 or physical
limitations sufficient to preclude participation in a 7 session outpatient
psychotherapy intervention.

- In the judgment of the consenting professional, severe psychiatric disturbance
sufficient that would preclude participation in the intervention (patients whose
psychiatric disorder is well controlled on medication will be eligible).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

A randomized controlled trial comparing the efficacy of Individual Meaning- Centered Psychotherapy (IMCP), a standardized Individual Supportive Psychotherapy (ISP) and Enhanced Usual Care (EUC)

Outcome Description:

in improving meaning and spiritual well-being and overall quality of life and reducing psychological distress (depression and anxiety, hopelessness and desire for hastened death) in a sample of patients with advanced cancer.

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

William Breitbart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-021

NCT ID:

NCT01323309

Start Date:

March 2011

Completion Date:

March 2015

Related Keywords:

  • Advanced Solid Tumor Diseases
  • Supportive Psychotherapy
  • Therapy
  • 11-021

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021