Trial of Individual Psychosocial Interventions for Cancer Patients

A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor Diseases
• Intervention / Treatment: Behavioral: Individual Meaning-Centered Psychotherapy (IMCP); Behavioral: standard Individual Supportive Psychotherapy (ISP); Behavioral: enhanced usual care (EUC)

• Study Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R)	The Life Attitude Profile-Revised (LAP-R) is a 48-item self-report measure of discovered meaning and purpose in life and the motivation to find meaning and purpose in life. There are 6 subscales: Purpose (8 items, Minimum 8, Maximum 56, Higher is better), Coherence (8 items, Minimum 8, Maximum 56, Higher is better), Life control (8 items, Minimum 8, Maximum 56, Higher is better), Death acceptance (8 items, Minimum 8, Maximum 56, Higher is better), Existential transcendence (16 items, Minimum 16, Maximum 112, Higher is better), Personal Meaning (16 items, Minimum 16, Maximum 112, Higher is better), Goal Seeking (8 items, Minimum 8, Maximum 56, Higher is better): LAP-R total score (48 items, Minimum 72, Maximum 504, Higher is better). The LAP-R total score is derived by summing all subscales.	baseline meaning making measures and again at post-intervention (approximately week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy	The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (SWB) comprises 12 items, each on a 0 ('Not at All') to 4 ('Very Much'). The SWB total score is derived by summing the responses, with a higher score representing high spiritual well-being. The minimum score is 0 and the maximum score is 48.	baseline meaning making measures and again at post-intervention (approximately week 8)
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),	Single Item Scale (SIS) from the McGill Quality of Life Questionnaire (MQOL): The McGill Quality Of Life Questionnaire is a 17-item scale, with each item rated on a scale of 0 to 10, divided into four domains (the Single-Item Scale (SIS), physical symptoms, feelings and thoughts, and social). It is a brief, self-report instrument designed to assess various domains of psychological, spiritual, and physical functioning among terminally ill patients. In this study the SIS from the MQOL was used. For each scale participants rate their current functioning on a scale of 0 to 10, 0 being Very Bad and 10 being Excellent, higher is better.	baseline meaning making measures and again at post-intervention (approximately week 8)
Whether an Enhanced Sense of Meaning "Explains" (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress).	The Schedule of Attitudes towards Hastened Death (SAHD) comprises 20 TRUE/FALSE questions on the presence or absence of attitudes towards hastened death. A scale score is derived by tallying the number of items endorsed. The minimum score is 0 (better, no thoughts on hastened death) and the maxim score is 20 (worst, many thoughts on hastened death).	4 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Fordham University
• Investigators: Principal Investigator: William Breitbart, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Marziliano A, Applebaum A, Moyer A, Pessin H, Rosenfeld B, Breitbart W. The Impact of Matching to Psychotherapy Preference on Engagement in a Randomized Controlled Trial for Patients With Advanced Cancer. Front Psychol. 2021 Feb 24;12:637519. doi: 10.3389/fpsyg.2021.637519. eCollection 2021.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2011
• Primary Completion (Actual): February 22, 2023
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimated): March 25, 2011

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Therapy; Supportive Psychotherapy; 11-021
• Other Study ID Numbers: 11-021