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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00984321
• Other study ID #: 09-116
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Gynecological Cancers
• Lung Cancer
• Lymphoma Cancer
• Prostate Cancer

Intervention

Behavioral:
• group intervention and questionnaires
Group Session will be 90 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient.
• individual phone intervention and questionnaires
Individual phone sessions will be 45 minutes long. Both the group sessions and individual session will be audio recorded. GSPI is a novel, manualized psychoeducational intervention that integrates Folkman's cognitive construct and Erikson's developmental concept of the 7th and 8th stages of life. GSPI consist of 5 weekly sessions. The first 2 sessions will be held on consecutive weeks to help establish rapport and explain therapeutic concepts, and next 3 sessions will be held every other week, giving patients time to utilize the therapeutic concepts and expanding length of contact with the patient.
• expressive writing (arm will not be include in the randomization)
intervention facilitate "reappraisal" through the exploration of past life events and prior successful ways of coping. Preliminary studies examining the efficacy of this writing intervention have shown its' ability to introduce patients to a new and effective coping method that can be utilized during future stressful cancer and aging related events.67 In the sessions, Wwe will explore past life events and ways of coping through manualized writing sessions.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Joan Karnell Cancer Center at Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Joan Karnell Cancer Center at Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence.		2 years
Secondary	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.		2 years

External Links

•   Memorial Sloan Kettering Cancer Center