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Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01586416
Recruitment Status : Unknown
Verified September 2015 by Lara Traeger, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2012
Last Update Posted : September 23, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lara Traeger, 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.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Behavioral: Behavioral Intervention Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 : December 2012
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : December 2015

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.

Primary Outcome Measures :
  1. 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.

  2. Number of participants who withdraw from study after enrollment [ Time Frame: At approximately 12 weeks post-baseline ]

Secondary Outcome Measures :
  1. Change from baseline in the Hospital Anxiety and Depression Scale [ Time Frame: At approximately 12 weeks post-baseline ]
  2. Change from baseline in the Symptom Distress Scale [ Time Frame: At approximately 12 weeks post-baseline ]
    The 13-item Symptom Distress Scale (SDS)measures physical and psychological symptom-related distress.

  3. Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount [ Time Frame: At approximately 24 weeks post-baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01586416

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
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Principal Investigator: Lara Traeger, PhD Massachusetts General Hospital

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Responsible Party: Lara Traeger, Assistant in Psychology, Massachusetts General Hospital Identifier: NCT01586416     History of Changes
Other Study ID Numbers: 1R03CA157200-01A1 ( U.S. NIH Grant/Contract )
1R03CA157200-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Lara Traeger, Massachusetts General Hospital:
Colonic neoplasms
Older adults
Psychosocial Intervention
Chemotherapy adherence

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases