Clinical trial NCT01323309: Trial of Individual Psychosocial Interventions for Cancer Patients
Official title: A Randomized Controlled Trial of Individual Psychosocial Interventions for Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Solid Tumor Diseases
Keywords: Supportive Psychotherapy
Therapy
11-021
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Fordham University
First posted: 2011-03-25
Enrollment: 346
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Participant Meaning Making Scores Using the Life Attitude Profile-Revised (LAP-R)
timeFrame: baseline meaning making measures and again at post-intervention (approximately week 8)
Secondary outcomes:
measure: Clinical and Demographic Variables That May Correspond to Differential Responses to Individual Meaning-Centered Psychotherapy
timeFrame: baseline meaning making measures and again at post-intervention (approximately week 8)
measure: 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),
timeFrame: baseline meaning making measures and again at post-intervention (approximately week 8)
measure: Whether an Enhanced Sense of Meaning "Explains" (Mediates) Improved Psychological Well-being (i.e., Increased Quality of Life, Decreased Psychological Distress).
timeFrame: 4 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Breitbart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.