NCT00984321Completed
A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 23 Sept 2009
- Start date
- 22 Sept 2009
- Primary completion date
- 12 Feb 2025
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Prostate cancer, Lung cancer
- NCT number
- NCT00984321
What you commit to
- Study type: Interventional
- Participants enrolled: 107
- From 22 Sept 2009 to the primary completion date, 12 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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.
Other illness
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention (e.g., acute psychiatric symptoms which requires individual treatment).
Other
- Actively participating in protocol 07-094 or 11-021
Who the study is looking for
- 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.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Joan Karnell Cancer Center at Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.