Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lara Traeger, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01586416
First received: April 24, 2012
Last updated: March 18, 2014
Last verified: March 2014
  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:


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: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Intervention
Brief behavioral intervention on 2-3 sessions of tailored cognitive-behavioral therapy to support chemotherapy adherence and well-being of patients completing chemotherapy for colon cancer.
Behavioral: Behavioral Intervention
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01586416

Contacts
Contact: Lara Traeger, PhD 617-643-4314 ltraeger@mgh.harvard.edu
Contact: Caitlin McCarty, BS cmmcarty@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lara Traeger, PhD    617-643-4314    ltraeger@mgh.harvard.edu   
Contact: Caitlin McCarty, BS       cmmcarty@mgh.harvard.edu   
Principal Investigator: Lara Traeger, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
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: March 18, 2014
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 August 19, 2014