Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

This study is ongoing, but not recruiting participants.
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: September 21, 2015
Last verified: September 2015

April 24, 2012
September 21, 2015
December 2012
September 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01586416 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Colonic Neoplasms
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.
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.
Intervention: Behavioral: Behavioral Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
December 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01586416
1R03CA157200-01A1, 1R03CA157200-01A1
No
Not Provided
Not Provided
Lara Traeger, Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Lara Traeger, PhD Massachusetts General Hospital
Massachusetts General Hospital
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP