Clinical Trial: Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Brief 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.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

  • Participant satisfaction with intervention structure, timing and content [ Time Frame: At approximately 12 weeks post-baseline ]
    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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in the Hospital Anxiety and Depression Scale [ Time Frame: At approximately 12 weeks post-baseline ]
  • Change from baseline in the Symptom Distress Scale [ Time Frame: At approximately 12 weeks post-baseline ]
    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 ]


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: April 24, 2012
Date Started: December 2012
Date Completion: December 2015
Last Updated: September 21, 2015
Last Verified: September 2015