Geriatric Group Psychoeducational Intervention for Elderly Patients With Cancer
This study is currently recruiting participants.
Verified June 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Joan Karnell Cancer Center at Pennsylvania Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00984321
First received: September 23, 2009
Last updated: June 13, 2013
Last verified: June 2013
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Purpose
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 | Intervention |
|---|---|
|
Breast Cancer Prostate Cancer Lung Cancer Lymphoma Cancer Gynecological Cancers |
Behavioral: group intervention and questionnaires Behavioral: individual phone intervention and questionnaires |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Pilot of a Geriatric Group Psychoeducational Intervention for Elderly Patients With Cancer |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: group intervention and questionnaires
This is a pilot study to examine the feasibility and utility of the Geriatric Specific Psychoeducational Intervention for Elderly Patients (GSPI) with prostate, breast, lung, lymphoma, and gynecological cancers.
|
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.
|
|
Experimental: individual phone intervention and questionnaires
This is a pilot study to examine the feasibility and utility of the Geriatric Specific Psychoeducational Intervention for Elderly Patients (GSPI) with prostate, breast lung, lymphoma, and gynecological cancers.
|
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.
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 at MSKCC
- 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 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 a group-format intervention (e.g., acute psychiatric symptoms which requires individual treatment).
- Actively participating in protocol 07-094 or 11-021
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984321
Contacts
| Contact: Andrew Roth, MD | 646-888-0024 | |
| Contact: Jimmie Holland, MD | 646-888-0026 |
Locations
| 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 Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Contact: Mark Moore, PhD | |
| Principal Investigator: Mark Moore, PhD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Joan Karnell Cancer Center at Pennsylvania Hospital
Investigators
| Principal Investigator: | Andrew Roth, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00984321 History of Changes |
| Other Study ID Numbers: | 09-116 |
| Study First Received: | September 23, 2009 |
| Last Updated: | June 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Geriatric Elderly Psychoeducational Counseling |
Depression Anxiety Intervention 09-116 |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Lymphoma Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013