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.
|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|
- 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 ]
- 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 ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586416
|Contact: Lara Traeger, PhDfirstname.lastname@example.org|
|Contact: Caitlin McCarty, BSemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Lara Traeger, PhD 617-643-4314 firstname.lastname@example.org|
|Contact: Caitlin McCarty, BS email@example.com|
|Principal Investigator: Lara Traeger, PhD|
|Principal Investigator:||Lara Traeger, PhD||Massachusetts General Hospital|