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Trial Title:
Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
NCT ID:
NCT01586416
Condition:
Colonic Neoplasms
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
Colonic neoplasms
Older adults
Psychosocial Intervention
Chemotherapy adherence
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Intervention
Description:
Two or three one-hour sessions of an individual behavioral intervention led by a
doctoral-level licensed psychologist during the first 12 weeks of chemotherapy.
Intervention addresses modifiable behaviors for managing chemotherapy challenges.
Arm group label:
Behavioral Intervention
Summary:
The purpose of this study is to develop and pilot test a behavioral intervention for
elderly adults in treatment for colon cancer, to enhance their skills for managing the
challenges of completing chemotherapy regimens. The investigators will assess feasibility
and acceptability of the intervention, and explore preliminary efficacy of the
intervention for reducing psychological distress and improving rates of optimal
chemotherapy adherence.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 60 or older
- Verbal fluency in English
- Diagnosis of colon cancer
- Scheduled to initiate chemotherapy treatment for colon cancer
Exclusion Criteria:
- Active, unstable, untreated serious mental illness interfering with ability to
participate
- Cognitive impairment interfering with ability to participate
- Receiving radiotherapy concomitant with chemotherapy
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Start date:
December 2012
Completion date:
December 2020
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01586416
