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Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Primary Purpose

Colonic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonic Neoplasms focused on measuring Colonic neoplasms, Older adults, Psychosocial Intervention, Chemotherapy adherence

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Participant satisfaction with intervention structure, timing and content
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

Secondary Outcome Measures

Change from baseline in the Hospital Anxiety and Depression Scale
Change from baseline in the Symptom Distress Scale
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

Full Information

First Posted
April 24, 2012
Last Updated
August 31, 2020
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01586416
Brief Title
Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
Official Title
Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Colonic neoplasms, Older adults, Psychosocial Intervention, Chemotherapy adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Intervention Description
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 Outcome Measure Information:
Title
Participant satisfaction with intervention structure, timing and content
Description
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.
Time Frame
At approximately 12 weeks post-baseline
Title
Number of participants who withdraw from study after enrollment
Time Frame
At approximately 12 weeks post-baseline
Secondary Outcome Measure Information:
Title
Change from baseline in the Hospital Anxiety and Depression Scale
Time Frame
At approximately 12 weeks post-baseline
Title
Change from baseline in the Symptom Distress Scale
Description
The 13-item Symptom Distress Scale (SDS)measures physical and psychological symptom-related distress.
Time Frame
At approximately 12 weeks post-baseline
Title
Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount
Time Frame
At approximately 24 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Traeger, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

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