Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

NCT01586416 | Unknown

• 1 other identifier: 1R03CA157200-01A1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms

Keywords

Colonic neoplasms; Older adults; Psychosocial Intervention; Chemotherapy adherence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change from baseline in the Hospital Anxiety and Depression Scale

  At approximately 12 weeks post-baseline

• Change from baseline in the Symptom Distress Scale

  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

Study Arms (1)

Behavioral Intervention

EXPERIMENTAL

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

Interventions

Behavioral Intervention BEHAVIORAL

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.

Behavioral Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 or older
• Verbal fluency in English
• Diagnosis of colon cancer
• Scheduled to initiate chemotherapy treatment for colon cancer

You may not qualify if:

• Active, unstable, untreated serious mental illness interfering with ability to participate
• Cognitive impairment interfering with ability to participate
• Receiving radiotherapy concomitant with chemotherapy

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lara Traeger, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychology

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 26, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)