Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

NCT ID: NCT01586416

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Colonic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lara Traeger

Assistant in Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lara Traeger, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R03CA157200-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1R03CA157200-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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