Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
|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|
|Actual 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 ]
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|