Trial of Individual Psychosocial Interventions for Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Fordham University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01323309
First received: March 24, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The aim of the study is to compare the benefits of three types of individual treatment programs for cancer patients: Meaning-Centered counseling, Supportive counseling, and Enhanced Usual Care.

We would like to train therapists in administering these types of counseling, so that they have expertise to work on the study. The therapists will administer either the Meaning-Centered counseling or the Supportive counseling, as part of their training.

Many cancer patients use counseling or other resources to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" counseling aims to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" counseling is intended to help the patient cope with cancer by giving them a place to express their feelings and get support. Enhanced Usual Care is intended to offer the patient referrals and resources that are matched to their individual needs in addition to the care they are already receiving at MSKCC.


Condition Intervention
Advanced Solid Tumor Diseases
Behavioral: Individual Meaning-Centered Psychotherapy (IMCP)
Behavioral: standard Individual Supportive Psychotherapy (ISP)
Behavioral: enhanced usual care (EUC)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • A randomized controlled trial comparing the efficacy of Individual Meaning- Centered Psychotherapy (IMCP), a standardized Individual Supportive Psychotherapy (ISP) and Enhanced Usual Care (EUC) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical and demographic variables that may correspond to differential responses to Individual Meaning-Centered Psychotherapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    (e.g., potential moderating influences such as gender, race/ethnicity, religiosity, level of pre-intervention social support, optimism, physical symptom burden, prognostic awareness, and treatment dose).

  • The relative impact of Individual Meaning-Centered Psychotherapy on different aspects of meaning (e.g., purpose, coherence, existential vacuum), as well as on different aspects of spiritual well-being (meaning versus faith), [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Whether an enhanced sense of meaning "explains" (mediates) improved psychological well-being (i.e., increased quality of life, decreased psychological distress). [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 414
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Individual Meaning-Centered Psychotherapy (IMCP) Behavioral: Individual Meaning-Centered Psychotherapy (IMCP)
IMCP is based on the principles of Viktor Frankl's Logotherapy, and is designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives even as they approach the end of life. IMCP is structured as a 7-session (1-hour weekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and advanced cancer. In addition we will be asking patients in the IMCP arm to complete an optional weekly session rating survey
standard Individual Supportive Psychotherapy (ISP) Behavioral: standard Individual Supportive Psychotherapy (ISP)
The ISP intervention utilized as the comparison treatment condition in this study, is adapted from the Supportive Group Psychotherapy manualized intervention developed by David Payne (1997) and adapted by Drs. Kissane, Breitbart and colleagues into the ISP manualized intervention. This intervention is a 7-session individual supportive psychotherapy utilizing an approach to supportive psychotherapy based on models described by Rogers. The essential components of supportive psychotherapy are integrated into this manualized intervention, including: reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis.
enhanced usual care (EUC) Behavioral: enhanced usual care (EUC)
We are therefore including what we refer to as an "enhanced" usual care arm to this randomized controlled trial to address the ethical issues raised by utilizing a usual care condition in a vulnerable advanced cancer population. Participants will receive feedback about their level of distress (based on the DT administered at screening) and given appropriate targeted referrals based on levels of distress and problem areas endorsed. Participants will be given a letter with a list of appropriate referrals.
Other Names:
  • Several referrals may be made based on identified problem areas, using the following guidelines:
  • • "Practical Problems" - Social Work on their disease management team
  • • "Family Problems"- Family Clinic at MSKCC Counseling Center
  • • "Emotional Problems" - MSKCC Counseling Center
  • • "Spiritual/Religious Concern"- Pastoral Care Counseling Services
  • • "Physical Problems"- MSKCC physician or MSKCC Palliative Care Service

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Potential candidates for the study who meet the eligibility criteria of cancer diagnosis and stage will be identified by the research staff and/or participating oncology staff or co-investigators. Study investigators in the Pain & Palliative Care Service the Breast Cancer Medicine Service, the Head & Neck Oncology Service, the Thoracic Medicine Service, the Gastrointestinal Oncology Service, and the Genito-Urinary Oncology Service will serve as liaisons to the Research Staff and help screen and identify potential subjects for the study.

Criteria

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).

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. or Patients with solid tumors with advanced disease receiving ambulatory care at MSKCC who have enrolled in this study, been assigned to the EUC arm, and completed all study requirements including follow-up assessments.

**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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323309

Contacts
Contact: William Breitbart, MD 646-888-0020
Contact: Wendy Lichtenthal, PhD 646-888-4812

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: William Breitbart, MD    646-888-0020      
Contact: Wendy Lichtenthal, PhD    646-888-4812      
Principal Investigator: William Breitbart, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Fordham University
Investigators
Principal Investigator: William Breitbart, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01323309     History of Changes
Other Study ID Numbers: 11-021
Study First Received: March 24, 2011
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Supportive Psychotherapy
Therapy
11-021

ClinicalTrials.gov processed this record on July 23, 2014