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

NCT00984321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Christian Nelson, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-22
Primary Completion
2025-02-12
Completion
2025-02-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00984321 on ClinicalTrials.gov