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Clinical Trials/NCT01586416
NCT01586416
Unknown
Not Applicable

Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Massachusetts General Hospital1 site in 1 country15 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonic Neoplasms
Sponsor
Massachusetts General Hospital
Enrollment
15
Locations
1
Primary Endpoint
Participant satisfaction with intervention structure, timing and content
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
December 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lara Traeger

Assistant in Psychology

Massachusetts General Hospital

Eligibility 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change from baseline in the Hospital Anxiety and Depression Scale(At approximately 12 weeks post-baseline)
  • Change from baseline in the Symptom Distress Scale(At approximately 12 weeks post-baseline)
  • Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount(At approximately 24 weeks post-baseline)

Study Sites (1)

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