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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms||Behavioral: Behavioral Intervention||Phase 1|
|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|
|Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2015|
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.
- 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.
- Number of participants who withdraw from study after enrollment [ Time Frame: At approximately 12 weeks post-baseline ]
- Change from baseline in the Hospital Anxiety and Depression Scale [ Time Frame: At approximately 12 weeks post-baseline ]
- 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.
- Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount [ Time Frame: At approximately 24 weeks post-baseline ]
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 ClinicalTrials.gov identifier (NCT number): NCT01586416
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Lara Traeger, PhD||Massachusetts General Hospital|