Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Colonic Neoplasms Clinical Trial

Official title:

Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01586416
• Other study ID #: 1R03CA157200-01A1
• Secondary ID: 1R03CA157200-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2020
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At approximately 12 weeks post-baseline
Primary	Number of participants who withdraw from study after enrollment		At approximately 12 weeks post-baseline
Secondary	Change from baseline in the Hospital Anxiety and Depression Scale		At approximately 12 weeks post-baseline
Secondary	Change from baseline in the Symptom Distress Scale	The 13-item Symptom Distress Scale (SDS)measures physical and psychological symptom-related distress.	At approximately 12 weeks post-baseline
Secondary	Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount		At approximately 24 weeks post-baseline