A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT00984321|
Recruitment Status : Recruiting
First Posted : September 25, 2009
Last Update Posted : December 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Prostate Cancer Lung Cancer Lymphoma Cancer Gynecological Cancers||Behavioral: group intervention and questionnaires Behavioral: individual phone intervention and questionnaires Behavioral: expressive writing (arm will not be include in the randomization)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
|Experimental: Psychoeducational Intervention Group||
Behavioral: 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.
|Experimental: Expressive Writing Intervention||
Behavioral: 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.
|Active Comparator: Control Group||
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.
- To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence. [ Time Frame: 2 years ]
- 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. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984321
|Contact: Andrew Roth, MD||646-888-0024|
|Contact: Jimmie Holland, MD||646-888-0026|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Andrew Roth, MD 646-888-0024|
|Principal Investigator: Andrew Roth, MD|
|United States, Pennsylvania|
|Joan Karnell Cancer Center at Pennsylvania||Completed|
|Philadelphia, Pennsylvania, United States, 19106|
|Principal Investigator:||Andrew Roth, MD||Memorial Sloan Kettering Cancer Center|