Clinical trial NCT00984321: A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer
Official title: A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Lung Cancer
Lymphoma Cancer
Gynecological Cancers
Keywords: Geriatric
Elderly
Counseling
Depression
Anxiety
Intervention
Psychoeducational
09-116
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Joan Karnell Cancer Center at Pennsylvania
First posted: 2009-09-25
Enrollment: 107
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine whether psychoeducation counseling for older cancer patients undergoing treatment is feasible and worthwhile. The investigators will test this in a group or individual phone counseling format. 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. This geriatric-specific psychoeducation is intended to help older cancer patients cope with the burden of cancer and aging. The purpose of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety, perception of loneliness and isolation. In addition this counseling aims to improve coping and quality of life (QOL).

Individuals who choose not to take part in the intervention study will be asked if they are willing to participate in a brief refusal sub study. The purpose of the refusal substudy is to compare levels of distress in patients that choose to participate and those that decline. This will yield valuable data that will help us distinguish between patients that decline due to lack of interest in research and those that decline due to high levels of distress. Participation in the refusal sub study consists of completion of 2 brief questionnaires.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of prostate, breast cancer lung, lymphoma, or gynecological.
* Are receiving active treatment (e.g., radiation, hormone, or chemotherapy)or have been receiving treatment in the past 6 months for prostate, breast, lung, lymphoma, or gynecological cancer
* Are 70 years old or older
* Greater than 6-months post diagnosis
* Have a Distress Thermometer score of 4 or greater or

a score of ≥ 6 on the Depression or Anxiety subscale of the HADS

* Have a Karnofsky Performance Rating of 60 or greater
* In the investigator's judgment, participants must have satisfactory cognitive function to provide valid informed consent and participate in Geriatric Specific Psychoeducational Intervention. The Blessed Orientation-Memory-Concentration test (BOMC) will be used as a cognitive screening tool. Patients must have a BOMC score of less than or equal to 11.
* Able to converse, write and read in English. The questionnaires were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require a very lengthy process of reestablishing the reliability and validity and the establishment of norms for these measures. Therefore, participants must be able to communicate in English to complete the questionnaires.

Exclusion Criteria:

* Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention (e.g., acute psychiatric symptoms which requires individual treatment).
* As per self-report or review of the patient's medical record, if the patient is taking anti-depressant medication, fewer than three months on the same dose of anti-depressant medication.
* Actively participating in protocol 07-094 or 11-021

Primary outcomes:
measure: To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence.
timeFrame: 2 years
Secondary outcomes:
measure: To examine the impact of these GSPI in both formats on depressive symptoms, anxiety, demoralization, coping, loneliness and isolation, and spirituality compared to the control group.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Joan Karnell Cancer Center at Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tutino RC, Saracino RM, Kelman J, Schofield EA, Roth AJ, Nelson CJ. Cancer and aging: Reflections for elders- Expressive writing intervention: A pilot study. J Geriatr Oncol. 2022 Jun;13(5):706-714. doi: 10.1016/j.jgo.2022.02.009. Epub 2022 Mar 2.