Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Not Applicable

• Conditions: Colonic Neoplasms
• Interventions: Behavioral: Behavioral Intervention

• Registration Number: NCT01586416
• Lead Sponsor: Massachusetts General Hospital

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Study Start: 2012-12
• Primary Completion: 2014-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Intervention	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.

Primary Outcome Measures

Name	Time	Method
Participant satisfaction with intervention structure, timing and content	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	At approximately 12 weeks post-baseline

Secondary Outcome Measures

Name	Time	Method
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	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	At approximately 24 weeks post-baseline

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States