Trial of Individual Psychosocial Interventions for Cancer Patients
|ClinicalTrials.gov Identifier: NCT01323309|
Recruitment Status : Active, not recruiting
First Posted : March 25, 2011
Last Update Posted : June 12, 2020
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 or disease||Intervention/treatment|
|Advanced Solid Tumor Diseases||Behavioral: Individual Meaning-Centered Psychotherapy (IMCP) Behavioral: standard Individual Supportive Psychotherapy (ISP) Behavioral: enhanced usual care (EUC)|
|Study Type :||Observational|
|Actual Enrollment :||346 participants|
|Official Title:||A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
|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.
- 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 ]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.
- Clinical and demographic variables that may correspond to differential responses to Individual Meaning-Centered Psychotherapy [ Time Frame: 4 years ](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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323309
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||William Breitbart, MD||Memorial Sloan Kettering Cancer Center|