Overview

This trial is active, not recruiting.

Condition colonic neoplasms
Treatment behavioral intervention
Phase phase 1
Sponsor Massachusetts General Hospital
Collaborator National Cancer Institute (NCI)
Start date December 2012
End date September 2014
Trial size 15 participants
Trial identifier NCT01586416, 1R03CA157200-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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 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.

Primary Outcomes

Measure
Participant satisfaction with intervention structure, timing and content
time frame: At approximately 12 weeks post-baseline
Number of participants who withdraw from study after enrollment
time frame: At approximately 12 weeks post-baseline

Secondary Outcomes

Measure
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
Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount
time frame: At approximately 24 weeks post-baseline

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
Principal investigator Lara Traeger, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.