Memorial Sloan Kettering Cancer Center
New York, 10065, United States
Completed
NCT Number: NCT01323309
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.
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Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Individual Meaning-Centered Psychotherapy (IMCP)
BehavioralIMCP 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)
BehavioralThe 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)
BehavioralWe 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
Primary outcomes
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Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R)
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
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.
Secondary outcomes
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Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy
Time frame: baseline meaning making measures and again at post-intervention (approximately week 8)
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.
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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: baseline meaning making measures and again at post-intervention (approximately week 8)
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.
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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
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).
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- Fordham University
- National Cancer Institute (NCI)
Registry information
Official study title
A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients
Important dates
- Study start
- 2011
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Mar 25, 2011
- Registry last updated
- Jul 1, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.