NCT02747160

Brief Summary

The purpose of this study is to examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. This study will also examine whether the intervention has a clinically significant impact on patient anxiety (primary outcome) and depression, distress, and quality of life (secondary outcomes).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

4.1 years

First QC Date

April 12, 2016

Last Update Submit

October 9, 2020

Conditions

AnxietyDepressionQuality of Life

Keywords

CancerAnxietyCognitive behavior therapyElderlyCaregivers

Outcome Measures

Primary Outcomes (3)

  • Intervention feasibility

    Attrition rates

    Post-intervention (6-8 weeks after baseline)

  • Intervention acceptability

    Likert scale ratings of perceived helpfulness and readability of the intervention

    Post-intervention (6-8 weeks after baseline)

  • Patient/caregiver adherence

    Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers

    Post-intervention (6-8 weeks after baseline)

Secondary Outcomes (4)

  • Change in anxiety from baseline to post-intervention

    Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

  • Change in distress from baseline to post-intervention

    Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

  • Emotional health-related quality of life

    Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

  • Change in depression from baseline to post-intervention

    Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

Study Arms (1)

Managing Anxiety from Cancer (MAC)

EXPERIMENTAL

Older adults with cancer and their primary informal caregiver will receive a six-session cognitive-behavior therapy intervention administered over the telephone by a trained study interventionist. The intervention is administered weekly and each session is 45-50 minutes in length. Patients and caregivers will receive the intervention independently and from separate therapists.

Behavioral: Managing Anxiety from Cancer (MAC)

Interventions

Managing Anxiety from Cancer (MAC)BEHAVIORAL

The intervention consists of six telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques (patient only), problem-solving strategies (caregiver only), and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer.

Managing Anxiety from Cancer (MAC)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient age 65 years or older
  • Diagnosis of cancer
  • Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale
  • A primary informal caregiver who is willing and able to participate
  • Patient and caregiver are able to communicate over the telephone
  • Caregiver is age 21 years or older.

You may not qualify if:

  • Patient or caregiver is not fluent in English
  • Patient or caregiver is too weak or cognitively impaired to participate in the intervention
  • Patient or caregiver has received CBT since the patient's cancer diagnosis
  • Patient or caregiver has an active major psychiatric condition such as schizophrenia
  • Patient only experiences anxiety in the context of a specific medical procedure
  • Patient or caregiver endorses active suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionNeoplasms

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Kelly M Trevino, PhD

    Weill Medical College of Cornell University

    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
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 21, 2016

Study Start

June 1, 2016

Primary Completion

July 2, 2020

Study Completion

July 2, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)