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Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

This study is not yet open for participant recruitment.
Verified April 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lara Traeger, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01586416
First received: April 24, 2012
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colonic Neoplasms
 Behavioral: Behavioral Intervention
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Participant satisfaction with intervention structure, timing and content [ Time Frame: At approximately 12 weeks post-baseline ] [ Designated as safety issue: No ]
    Participants rate acceptability of structure, timing and content of intervention using Likert-type response scales, and are also invited to provide brief qualitative feedback on opinions about intervention.

  • Number of participants who withdraw from study after enrollment [ Time Frame: At approximately 12 weeks post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the Hospital Anxiety and Depression Scale [ Time Frame: At approximately 12 weeks post-baseline ] [ Designated as safety issue: No ]
  • Change from baseline in the Symptom Distress Scale [ Time Frame: At approximately 12 weeks post-baseline ] [ Designated as safety issue: No ]
    The 13-item Symptom Distress Scale (SDS)measures physical and psychological symptom-related distress.

  • Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount [ Time Frame: At approximately 24 weeks post-baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Behavioral Intervention
    Approximately 8 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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 65 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586416

Contacts
Contact: Lara Traeger, PhD 617-643-4314 ltraeger@partners.org
Contact: Jesse Kosiba, BS 617-724-0637 jkosiba1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Lara Traeger, PhD     617-643-4314     ltraeger@partners.org    
Contact: Jesse Kosiba, BS     617-724-0637     jkosiba1@partners.org    
Principal Investigator: Lara Traeger, PhD            
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lara Traeger, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Lara Traeger, Assistant in Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01586416     History of Changes
Other Study ID Numbers: 1R03CA157200-01A1, 1R03CA157200-01A1
Study First Received: April 24, 2012
Last Updated: April 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Colonic neoplasms
Older adults
Psychosocial Intervention
Chemotherapy adherence

Additional relevant MeSH terms:
Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 17, 2012