Geriatric Group Psychoeducational Intervention for Elderly Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
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: August 18, 2014
Last verified: August 2014
  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: 98
Study Start Date: September 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 18, 2014
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:
Prostatic Neoplasms
Breast Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014