A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:70 - Any
Updated:12/13/2018
Start Date:September 2009
End Date:September 2019
Contact:Andrew Roth, MD
Phone:646-888-0024

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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.


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
We found this trial at
2
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Andrew Roth, MD
Phone: 646-888-0024
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19106
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