Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01586416

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Behavioral: Behavioral Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital
National Cancer Institute (NCI)

Investigators

Principal Investigator: Lara Traeger, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lara Traeger, Assistant in Psychology, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01586416

Other Study ID Numbers:

1R03CA157200-01A1
1R03CA157200-01A1

First Posted:

Apr 26, 2012

Last Update Posted:

Sep 2, 2020

Last Verified:

Aug 1, 2020

Keywords provided by Lara Traeger, Assistant in Psychology, Massachusetts General Hospital

Colonic neoplasms

Older adults

Psychosocial Intervention

Chemotherapy adherence

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Sep 2, 2020