Trial of Individual Psychosocial Interventions for Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients

Conditions
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Advanced Solid Tumor Diseases

Intervention / Treatment
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* Behavioral: Individual Meaning-Centered Psychotherapy (IMCP)
* Behavioral: standard Individual Supportive Psychotherapy (ISP)
* Behavioral: enhanced usual care (EUC)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individual Meaning-Centered Psychotherapy (IMCP)<br> | Behavioral: Individual Meaning-Centered Psychotherapy (IMCP)<br>* 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<br>|
| standard Individual Supportive Psychotherapy (ISP)<br> | Behavioral: standard Individual Supportive Psychotherapy (ISP)<br>* 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.<br>|
| enhanced usual care (EUC)<br> | Behavioral: enhanced usual care (EUC)<br>* 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.<br>* Other names: • Physical Problems- MSKCC physician or MSKCC Palliative Care Service;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A randomized controlled trial comparing the efficacy of Individual Meaning- Centered Psychotherapy (IMCP), a standardized Individual Supportive Psychotherapy (ISP) and Enhanced Usual Care (EUC) | 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and demographic variables that may correspond to differential responses to Individual Meaning-Centered Psychotherapy | (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). | 4 years | 
| 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), |  | 4 years | 
| Whether an enhanced sense of meaning explains (mediates) improved psychological well-being (i.e., increased quality of life, decreased psychological distress). |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supportive Psychotherapy, Therapy, 11-021