Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01586416

Enrollment

Registered

2012-04-26

Start date

2012-12-31

Completion date

2020-12-31

Last updated

2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms

Keywords

Colonic neoplasms, Older adults, Psychosocial Intervention, Chemotherapy adherence

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.

Interventions

BEHAVIORALBehavioral 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Participant satisfaction with intervention structure, timing and content	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	At approximately 12 weeks post-baseline	—

Secondary

Measure	Time frame	Description
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	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	At approximately 24 weeks post-baseline	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026