Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Behavioral: Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of participants who withdraw from study after enrollment |  | At approximately 12 weeks post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Hospital Anxiety and Depression Scale |  | At approximately 12 weeks post-baseline | 
| 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 | 
| Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount |  | At approximately 24 weeks post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic neoplasms, Older adults, Psychosocial Intervention, Chemotherapy adherence