Clinical trial NCT00133965: Psychosocial Support for Cancer Patients
Official title: Psychosocial Support for Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Advanced Cancer
Dignity Care
Supportive Care
Quality of Life
Psychotherapy
Palliative Care
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Manitoba
name: Edith Cowan University
name: Visiting Nurse Service of New York
First posted: 2005-08-24
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Pain and Palliative Care Service and Gastrointestinal Service of the Memorial Sloan Kettering Cancer Center.

Brief summary: This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing 120 patients per site (120x3). The purpose of this study is to compare two types of counseling for cancer patients: "Dignity Psychotherapy" and "Supportive Psychotherapy" as well as "Standard Palliative Care." Many cancer patients seek counseling 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. We, the investigators at Memorial Sloan-Kettering Cancer Center, have developed a type of counseling we call "Dignity Psychotherapy." It is intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall quality of life, despite having cancer. "Supportive Psychotherapy" is another type of counseling intended to help patients feel more at ease and express and reflect on any feelings or concerns they might have about their illness. Both of these types of counseling will be compared to "Standard Palliative Care." We will look at how these types of treatments affect patients' mood, outlook, and quality of life. We also want to see how the type of treatment they receive affects their family members and significant others.

Detailed description: Primary Objective:

* To establish the efficacy of a new and unique individual, brief intervention we call "Dignity Psychotherapy" in enhancing a sense of meaning, purpose and overall well-being for patients with advanced, end stage cancer.

Secondary Objectives:

* To compare the effectiveness of "Dignity Psychotherapy" with "Supportive Psychotherapy" and "Standard Palliative Care" in bolstering the patients' sense of meaning, purpose, generativity, and overall sense of dignity and quality of life, while lessening hopelessness, sense of being a burden to others, and suffering.
* To explore the impact "Dignity Psychotherapy" has on the bereavement experience of those family members/significant others taking part in this arm of the study protocol.
* To compare the bereavement experience of bereaved family members/significant others whose loved ones took part in any one of the three study conditions.

Eligibility criteria: Inclusion Criteria:

* The patient must be at least 18 years of age (because of the nature of "Dignity Psychotherapy," which presumes a relatively advanced level of social and psychological development).
* Have a terminal illness (Stage IV with a prognosis of less than 6 months, but expected to live at least 7 to 10 days, i.e. the average length of the protocol)
* Must be able to identify a family member/significant other who agrees to participate in the study (in the case of "Dignity Psychotherapy," this family member/significant other will receive the generativity document)
* Be able to communicate with an English-speaking therapist (patients who are visually impaired will be offered assistance with the consent forms and surveys)
* In the investigator's judgement, participant is cognitively able to provide valid, informed consent.

Exclusion Criteria:

* Significant psychiatric disturbance sufficient to preclude participation in a psychotherapeutic intervention (e.g. acute, severe psychiatric symptoms which would require individual treatment and medication management rather than a psychotherapy intervention).
* Active psychotic mental disorder (e.g. schizophrenia, acute mania), or marked paranoid ideation. Patients who are on stable regimens of psychotropic medications (e.g. antidepressants for clinical depression) or who are in concurrent individual or group psychotherapy will not be excluded. This information regarding concurrent psychiatric treatment will be collected and utilized as a co-variate in data analysis.
* Presence of a cognitive disturbance (i.e. delirium or dementia) sufficient to preclude participation in psychotherapy, and/or data collection.
* Physical limitations or illness severity sufficient to preclude participation in psychotherapy

Primary outcomes:
measure: To establish the efficacy of a new and unique individual, brief intervention called "Dignity Psychotherapy" in enhancing a sense of meaning, purpose and overall well-being for patients with advanced, end stage cancer
timeFrame: 7-10 days
Secondary outcomes:
measure: To compare the effectiveness of "Dignity Psychotherapy" with "Supportive Psychotherapy" and "Standard Palliative Care" in bolstering the patients' sense of meaning
timeFrame: 7-10 days
measure: To explore the impact "Dignity Psychotherapy" has on the bereavement experience of those family members/significant others taking part in this arm of the study protocol
timeFrame: 7-10 days
measure: To compare the bereavement experience of bereaved family members/significant others whose loved ones took part in any one of the three study conditions
timeFrame: Six to nine months following the death of the patient
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: Chochinov HM, Kristjanson LJ, Breitbart W, McClement S, Hack TF, Hassard T, Harlos M. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol. 2011 Aug;12(8):753-62. doi: 10.1016/S1470-2045(11)70153-X. Epub 2011 Jul 6.